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Evaluate the Safety and Efficacy of 48-Hour Infusions of HNO (Nitroxyl) Donor in Hospitalized Patients With Heart Failure (STANDUP AHF)

Primary Purpose

Heart Failure

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

HNO Donor

Placebo

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Actively being hospitalized for acute decompensated heart failure
At least 1 administration of IV diuretic for the current episode
Be randomized within 18 hours of first dose of IV diuretic for current episode for Part 1 Cohort 1, or 48 hours for first dose for Part II Cohort II
Have shortness of breath at rest or with minimal exertion after administration of 1 dose of IV diuretic
Have history of heart failure and a left ventricular ejection fraction (LVEF) ≤ 40%

Exclusion Criteria:

Systolic blood pressure <105mm Hg or >160mm Hg or heart rate <50 or >130 bpm
Have an active infection requiring IV anti-microbial treatment
Be hospitalized with acute coronary syndrome, coronary revascularization or acute myocardial infarction during the previous 90 days prior to screening
Have a history of a cerebral vascular accident (CVA or stroke) or of a transient ischemic attack (TIA) during the previous 90 days prior to screening
Suspected acute lung disease (e.g pneumonia or asthma) or severe chronic lung disease (e.g. severe chronic obstructive pulmonary disease, or pulmonary fibrosis)

Other protocol defined inclusion/exclusion criteria could apply

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Part 1 Cohort 1 HNO Donor

Placebo Part 1 Cohort 1

Part 2 Cohort 2 HNO Donor- low dose

Part 2 Cohort 2 HNO Donor- high dose

Placebo Part 2 Cohort 2

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion

Percentage of participants with clinically relevant hypotension, defined by systolic blood pressure (SBP) < 90 mm Hg (confirmed by a repeated value < 90 mm Hg) or symptoms of hypotension, up to 6 hours after the end of study drug infusion

Secondary Outcome Measures

Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32

Assess the effect of BMS-986231 on NT-proBNP (N-terminal prohormone of brain natriuretic peptide)

Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72

Endpoint was measured by the area under the curve (AUC) of the 11-point Numerical Rating Scale (NRS) obtained at baseline, and Hours 6, 12, 24, 48, and 72. Participants were asked to report their absolute current severity of dyspnea on an 11-point numerical rating scale (NRS; range 0 to 10). The numerical rating scale (NRS) was used to assess the degree of dyspnea (breathlessness), measured using an 11-point scale provided by the Sponsor. A score of 0 represents "I am not breathless at all" and 10 represents "I am the most breathless I can possibly imagine".

Percentage of Participants With Symptomatic Hypotension up to 6 Hours After the End of Study Drug Infusion

The percentage of participants experiencing symptoms of hypotension up to 6 hours post-treatment was reported for each arm.

Percentage of Participants With SBP < 90 mm Hg (Confirmed by a Repeated Value)

The percentage of participants experiencing SBP < 90 mm Hg (confirmed by a repeated value) up to 6 hours post-treatment was reported for each arm.

Number of Participants With a Serious Adverse Events (SAE) Assessed up to Day 32

Number of participants who experienced an in-study SAE. Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 Included serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment.

Number of Participants Who Discontinued Due to Hypotension

Number of participants who discontinued study treatment due to hypotension. Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Hypotension defined as systolic blood pressure (SBP) < 90 mmHg.

Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure

Number of participants who discontinued study treatment, experienced a down-titration (dose reduction) or dose interruption due to decreased blood pressure/hypotension are reported below. Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. If the participant experienced systolic blood pressure (SBP) < 95 mm Hg, without symptoms related to hypotension, the measurement was repeated within 15 minutes. If the SBP remained < 95 mm Hg, the dose reduction occurred.

Number of Participants With an Adverse Event (AE) Assessed up to 120 Hours

Number of participants who experienced an in-study AE. Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment.

Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182

Number of participants who died (all- cause and CV related) through Day 182. Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 CV=Cardiovascular

Change in Troponin T From Baseline to Hour 24, 48, and 72

Baseline = Last non-missing result with a collection date-time less than or on the date-time of the start of infusion of study drug

Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology

Number of participants who experienced an in-study Hematology marked laboratory abnormality (reported in > 5% of total participants). Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0

Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry

Number of participants who experienced an in-study Chemistry marked laboratory abnormality (reported in > 5% of total participants). Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0

Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis

Number of participants who experienced an in-study Urinalysis marked laboratory abnormality (reported in > 5% of total participants). Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0

Change in Vital Signs From Baseline to 120 Hours - Blood Pressure

The change in baseline for vital signs was reported for each arm.

Change in Vital Signs From Baseline to 120 Hours - Heart Rate

The change in baseline for vital signs was reported for each arm.

Change in Vital Signs From Baseline to 120 Hours - Respiratory Rate

The change in baseline for vital signs was reported for each arm.

Change in Vital Signs From Baseline to 120 Hours - Temperature

The change in baseline for vital signs was reported for each arm.

Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - Mean Heart Rate

The change in baseline for ECGs was reported for each arm.

Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration

The change in baseline for ECGs was reported for each arm.

Change in Physical Measurements From Baseline to 120 Hours

The change in baseline for physical measurements was reported for each arm.

Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^9 Cells/L

The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.

Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - g/L

The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.

Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L

The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.

Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L

The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.

Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mg/dL

The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.

Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^12 c/L

The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.

Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Protein (Nmol/L)

The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.

Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Creatinine (µmol/L)

The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.

Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Cystatin (mg/L)

The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.

Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Potassium Excretion

The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.

Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Sodium Excretion

The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.

Full Information

NCT ID

NCT03016325

First Posted

January 9, 2017

Last Updated

December 11, 2020

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT03016325

Brief Title

Evaluate the Safety and Efficacy of 48-Hour Infusions of HNO (Nitroxyl) Donor in Hospitalized Patients With Heart Failure

Acronym

STANDUP AHF

Official Title

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Ranging, Phase 2b Study of the Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of BMS-986231 in Hospitalized Patients With Heart Failure and Impaired Systolic Function

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

January 13, 2017 (Actual)

Primary Completion Date

June 23, 2019 (Actual)

Study Completion Date

November 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A Study to Evaluate Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of HNO Donor in Hospitalized Patients with Heart Failure and Impaired Systolic Function

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

329 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1 Cohort 1 HNO Donor

Arm Type

Experimental

Arm Title

Placebo Part 1 Cohort 1

Arm Type

Placebo Comparator

Arm Title

Part 2 Cohort 2 HNO Donor- low dose

Arm Type

Experimental

Arm Title

Part 2 Cohort 2 HNO Donor- high dose

Arm Type

Experimental

Arm Title

Placebo Part 2 Cohort 2

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

HNO Donor

Other Intervention Name(s)

BMS-986231

Intervention Description

Infusion

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Infusion

Primary Outcome Measure Information:

Title

Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion

Description

Time Frame

From start of infusion up to 6 hours post end of infusion

Secondary Outcome Measure Information:

Title

Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32

Description

Assess the effect of BMS-986231 on NT-proBNP (N-terminal prohormone of brain natriuretic peptide)

Time Frame

0, 24, 48, 72, 120 hour or discharge; Day 32

Title

Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72

Description

Time Frame

Hours 6, 12, 24, 48, and 72

Title

Percentage of Participants With Symptomatic Hypotension up to 6 Hours After the End of Study Drug Infusion

Description

The percentage of participants experiencing symptoms of hypotension up to 6 hours post-treatment was reported for each arm.

Time Frame

From start of infusion up to 6 hours post end of infusion

Title

Percentage of Participants With SBP < 90 mm Hg (Confirmed by a Repeated Value)

Description

The percentage of participants experiencing SBP < 90 mm Hg (confirmed by a repeated value) up to 6 hours post-treatment was reported for each arm.

Time Frame

From start of infusion up to 6 hours post end of infusion

Title

Number of Participants With a Serious Adverse Events (SAE) Assessed up to Day 32

Description

Time Frame

32 days

Title

Number of Participants Who Discontinued Due to Hypotension

Description

Time Frame

up to 120 hours (for AEs); up to 32 days (for SAEs)

Title

Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure

Description

Time Frame

up to 120 hours (for AEs); up to 32 days (for SAEs)

Title

Number of Participants With an Adverse Event (AE) Assessed up to 120 Hours

Description

Time Frame

up to 120 hours

Title

Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182

Description

Number of participants who died (all- cause and CV related) through Day 182. Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 CV=Cardiovascular

Time Frame

through 182 days

Title

Change in Troponin T From Baseline to Hour 24, 48, and 72

Description

Baseline = Last non-missing result with a collection date-time less than or on the date-time of the start of infusion of study drug

Time Frame

from baseline to Hour 24, 48, and 72

Title

Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology

Description

Time Frame

to 120 hours

Title

Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry

Description

Time Frame

to 120 hours

Title

Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis

Description

Time Frame

to 120 hours

Title

Change in Vital Signs From Baseline to 120 Hours - Blood Pressure

Description

The change in baseline for vital signs was reported for each arm.

Time Frame

to 120 hours

Title

Change in Vital Signs From Baseline to 120 Hours - Heart Rate

Description

The change in baseline for vital signs was reported for each arm.

Time Frame

to 120 hours

Title

Change in Vital Signs From Baseline to 120 Hours - Respiratory Rate

Description

The change in baseline for vital signs was reported for each arm.

Time Frame

to 120 hours

Title

Change in Vital Signs From Baseline to 120 Hours - Temperature

Description

The change in baseline for vital signs was reported for each arm.

Time Frame

to 120 hours

Title

Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - Mean Heart Rate

Description

The change in baseline for ECGs was reported for each arm.

Time Frame

to 120 hours

Title

Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration

Description

The change in baseline for ECGs was reported for each arm.

Time Frame

to 120 hours

Title

Change in Physical Measurements From Baseline to 120 Hours

Description

The change in baseline for physical measurements was reported for each arm.

Time Frame

to 120 hours

Title

Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^9 Cells/L

Description

The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.

Time Frame

to 120 hours

Title

Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - g/L

Description

The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.

Time Frame

to 120 hours

Title

Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L

Description

The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.

Time Frame

to 120 hours

Title

Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L

Description

The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.

Time Frame

to 120 hours

Title

Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mg/dL

Description

The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.

Time Frame

to 120 hours

Title

Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^12 c/L

Description

The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.

Time Frame

to 120 hours

Title

Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Protein (Nmol/L)

Description

The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.

Time Frame

to 120 hours

Title

Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Creatinine (µmol/L)

Description

The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.

Time Frame

to 120 hours

Title

Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Cystatin (mg/L)

Description

The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.

Time Frame

to 120 hours

Title

Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Potassium Excretion

Description

The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.

Time Frame

to 120 hours

Title

Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Sodium Excretion

Description

The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.

Time Frame

to 120 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Actively being hospitalized for acute decompensated heart failure At least 1 administration of IV diuretic for the current episode Be randomized within 18 hours of first dose of IV diuretic for current episode for Part 1 Cohort 1, or 48 hours for first dose for Part II Cohort II Have shortness of breath at rest or with minimal exertion after administration of 1 dose of IV diuretic Have history of heart failure and a left ventricular ejection fraction (LVEF) ≤ 40% Exclusion Criteria: Systolic blood pressure <105mm Hg or >160mm Hg or heart rate <50 or >130 bpm Have an active infection requiring IV anti-microbial treatment Be hospitalized with acute coronary syndrome, coronary revascularization or acute myocardial infarction during the previous 90 days prior to screening Have a history of a cerebral vascular accident (CVA or stroke) or of a transient ischemic attack (TIA) during the previous 90 days prior to screening Suspected acute lung disease (e.g pneumonia or asthma) or severe chronic lung disease (e.g. severe chronic obstructive pulmonary disease, or pulmonary fibrosis) Other protocol defined inclusion/exclusion criteria could apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

University of Arizona Sarver Heart Center

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Facility Name

Tampa General Hospital

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Facility Name

Emory University

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Indiana University Health Methodist Hospital

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

University of Maryland Medical Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

DMC Detroit Receiving Hospital

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Harper University Hospital

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Henry Ford Health System

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Sinai Grace Hospital

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48235

Country

United States

Facility Name

Saint Louis University

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Washington University

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

University of North Carolina at Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

University of Cincinnati

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

Facility Name

Wexner Medical Center at The Ohio State University

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Thomas Jefferson University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Medical University of South Carolina - PPDS

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

University of Texas Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

Ben Taub General Hospital

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

University of Utah Medical Center

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

University of Virginia Health System

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Facility Name

Local Institution

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1428ART

Country

Argentina

Facility Name

Local Institution

City

Rosario

State/Province

Santa FE

ZIP/Postal Code

Santa Fe, 2000

Country

Argentina

Facility Name

Local Institution

City

Buenos Aires

Country

Argentina

Facility Name

Local Institution

City

Cordoba

ZIP/Postal Code

5000

Country

Argentina

Facility Name

Local Institution

City

Cordoba

ZIP/Postal Code

X5000AAX

Country

Argentina

Facility Name

Local Institution

City

Cordoba

ZIP/Postal Code

X5000EPU

Country

Argentina

Facility Name

Local Institution

City

Cordoba

ZIP/Postal Code

X5000JHQ

Country

Argentina

Facility Name

Local Institution

City

Cordoba

Country

Argentina

Facility Name

Local Institution

City

Corrientes

ZIP/Postal Code

3400

Country

Argentina

Facility Name

Local Institution

City

Santa Fe

ZIP/Postal Code

3000

Country

Argentina

Facility Name

Local Institution

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2R3

Country

Canada

Facility Name

Local Institution

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 4S9

Country

Canada

Facility Name

Local Institution

City

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

Facility Name

Local Institution

City

Brno

ZIP/Postal Code

625 00

Country

Czechia

Facility Name

Local Institution

City

Brno

ZIP/Postal Code

656 91

Country

Czechia

Facility Name

Local Institution

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Local Institution

City

Plzen-Bory

ZIP/Postal Code

305 99

Country

Czechia

Facility Name

Local Institution

City

Prague

ZIP/Postal Code

12808

Country

Czechia

Facility Name

Local Institution

City

Praha 4

ZIP/Postal Code

140 21

Country

Czechia

Facility Name

Local Institution

City

Slany

ZIP/Postal Code

274 01

Country

Czechia

Facility Name

Local Institution

City

Besancon

ZIP/Postal Code

25000

Country

France

Facility Name

Local Institution

City

Beziers

ZIP/Postal Code

34500

Country

France

Facility Name

Local Institution

City

Bobigny

ZIP/Postal Code

93009

Country

France

Facility Name

Local Institution

City

Creteil

Country

France

Facility Name

Local Institution

City

Evreux

ZIP/Postal Code

27015

Country

France

Facility Name

Local Institution

City

La Tronche

ZIP/Postal Code

38700

Country

France

Facility Name

Local Institution

City

Paris Cedex 10

ZIP/Postal Code

75475

Country

France

Facility Name

Local Institution

City

Paris

ZIP/Postal Code

75013

Country

France

Facility Name

Local Institution

City

Bad Nauheim

ZIP/Postal Code

61231

Country

Germany

Facility Name

Local Institution

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Local Institution

City

Gottingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Local Institution

City

Greifswald

Country

Germany

Facility Name

Local Institution

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Local Institution

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Local Institution

City

Homburg

ZIP/Postal Code

66421

Country

Germany

Facility Name

Local Institution

City

Ludwigshafen

ZIP/Postal Code

67063

Country

Germany

Facility Name

Local Institution

City

Mainz

Country

Germany

Facility Name

Local Institution

City

Regensburg

ZIP/Postal Code

935053

Country

Germany

Facility Name

Local Institution

City

Athens, Attiki

ZIP/Postal Code

11527

Country

Greece

Facility Name

Local Institution

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

Local Institution

City

Athens

ZIP/Postal Code

12464

Country

Greece

Facility Name

Local Institution

City

Athens

ZIP/Postal Code

14233

Country

Greece

Facility Name

Local Institution

City

Ioannina

ZIP/Postal Code

45500

Country

Greece

Facility Name

Local Institution

City

Kallithea

ZIP/Postal Code

17674

Country

Greece

Facility Name

Local Institution

City

Larisa

ZIP/Postal Code

41110

Country

Greece

Facility Name

Local Institution

City

Thessaloniki

ZIP/Postal Code

54636

Country

Greece

Facility Name

Local Institution

City

Brescia

ZIP/Postal Code

25123

Country

Italy

Facility Name

Local Institution

City

Ferrara

ZIP/Postal Code

44121

Country

Italy

Facility Name

Local Institution

City

Foggia

ZIP/Postal Code

71121

Country

Italy

Facility Name

Local Institution

City

Nagoya-shi

State/Province

Aichi

ZIP/Postal Code

4678602

Country

Japan

Facility Name

Local Institution

City

Seto

State/Province

Aichi

ZIP/Postal Code

489-0065

Country

Japan

Facility Name

Local Institution

City

Fukushima-shi

State/Province

Fukushima

ZIP/Postal Code

9601295

Country

Japan

Facility Name

Local Institution

City

Sapporo-shi

State/Province

Hokkaido

ZIP/Postal Code

0608648

Country

Japan

Facility Name

Local Institution

City

Amagasaki

State/Province

Hyogo

ZIP/Postal Code

6608550

Country

Japan

Facility Name

Local Institution

City

Sagamihara-shi

State/Province

Kanagawa

ZIP/Postal Code

2520375

Country

Japan

Facility Name

Local Institution

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

227-8501

Country

Japan

Facility Name

Local Institution

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

232-0024

Country

Japan

Facility Name

Local Institution

City

Okayama-shi

State/Province

Okayama

ZIP/Postal Code

7008558

Country

Japan

Facility Name

Local Institution

City

Suita-shi

State/Province

Osaka

Country

Japan

Facility Name

Local Institution

City

Kawaguchi

State/Province

Saitama

ZIP/Postal Code

333-0842

Country

Japan

Facility Name

Local Institution

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

1138431

Country

Japan

Facility Name

Local Institution

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

1138603

Country

Japan

Facility Name

Local Institution

City

Itabashi-ku

State/Province

Tokyo

ZIP/Postal Code

1738610

Country

Japan

Facility Name

Local Institution

City

Osaka

ZIP/Postal Code

558-8558

Country

Japan

Facility Name

Local Institution

City

Tokyo

ZIP/Postal Code

113-8655

Country

Japan

Facility Name

Local Institution

City

Tokyo

ZIP/Postal Code

162-8655

Country

Japan

Facility Name

Local Institution

City

Amersfoort

ZIP/Postal Code

3818 ES

Country

Netherlands

Facility Name

Local Institution

City

Deventer

ZIP/Postal Code

7416 SE

Country

Netherlands

Facility Name

Local Institution

City

Hardenberg

ZIP/Postal Code

7772 SE

Country

Netherlands

Facility Name

Local Institution

City

Leeuwarden

ZIP/Postal Code

8934 AD

Country

Netherlands

Facility Name

Local Institution

City

Bialystok

ZIP/Postal Code

15-276

Country

Poland

Facility Name

Local Institution

City

Katowice

ZIP/Postal Code

40-635

Country

Poland

Facility Name

Local Institution

City

Krakow

ZIP/Postal Code

31-202

Country

Poland

Facility Name

Local Institution

City

Lodz

ZIP/Postal Code

91-347

Country

Poland

Facility Name

Local Institution

City

Lodz

ZIP/Postal Code

92-213

Country

Poland

Facility Name

Local Institution

City

Warszawa

ZIP/Postal Code

04-628

Country

Poland

Facility Name

Local Institution

City

Wroclaw

ZIP/Postal Code

50-981

Country

Poland

Facility Name

Local Institution

City

Wroclaw

ZIP/Postal Code

54-049

Country

Poland

Facility Name

Local Institution

City

Zamosc

ZIP/Postal Code

22-400

Country

Poland

Facility Name

Local Institution

City

Alicante

ZIP/Postal Code

03010

Country

Spain

Facility Name

Local Institution

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Local Institution

City

Barcelona

ZIP/Postal Code

8035

Country

Spain

Facility Name

Local Institution

City

L'Hospitalet de Llobregat

ZIP/Postal Code

08907

Country

Spain

Facility Name

Local Institution

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Local Institution

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Local Institution

City

Sant Joan Despi

ZIP/Postal Code

08970

Country

Spain

Facility Name

Local Institution

City

Santiago De Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

Local Institution

City

Belfast

ZIP/Postal Code

BT16 1RH

Country

United Kingdom

Facility Name

Local Institution

City

Blackpool

ZIP/Postal Code

FY3 8NR

Country

United Kingdom

Facility Name

Local Institution

City

Glasgow

ZIP/Postal Code

G4 0SF

Country

United Kingdom

Facility Name

Local Institution

City

Glasgow

ZIP/Postal Code

G51 4TF

Country

United Kingdom

Facility Name

Local Institution

City

London

ZIP/Postal Code

SW17 0QT

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

33248986

Citation

Felker GM, McMurray JJV, Cleland JG, O'Connor CM, Teerlink JR, Voors AA, Belohlavek J, Bohm M, Borentain M, Bueno H, Cole RT, DeSouza MM, Ezekowitz JA, Filippatos G, Lang NN, Kessler PD, Martinez FA, Mebazaa A, Metra M, Mosterd A, Pang PS, Ponikowski P, Sato N, Seiffert D, Ye J. Effects of a Novel Nitroxyl Donor in Acute Heart Failure: The STAND-UP AHF Study. JACC Heart Fail. 2021 Feb;9(2):146-157. doi: 10.1016/j.jchf.2020.10.012. Epub 2020 Nov 25.

Results Reference

derived

PubMed Identifier

30703258

Citation

Cowart D, Venuti RP, Lynch K, Guptill JT, Noveck RJ, Foo SY. A Phase 1 Randomized Study of Single Intravenous Infusions of the Novel Nitroxyl Donor BMS-986231 in Healthy Volunteers. J Clin Pharmacol. 2019 May;59(5):717-730. doi: 10.1002/jcph.1364. Epub 2019 Jan 31.

Results Reference

derived

Links:

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Description

BMS Clinical Trial Information

URL

https://www.bmsstudyconnect.com/s/US/English/USenHome

Description

BMS Clinical Trial Patient Recruiting

URL

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

Description

FDA Safety Alerts and Recalls

Learn more about this trial

Evaluate the Safety and Efficacy of 48-Hour Infusions of HNO (Nitroxyl) Donor in Hospitalized Patients With Heart Failure

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Evaluate the Safety and Efficacy of 48-Hour Infusions of HNO (Nitroxyl) Donor in Hospitalized Patients With Heart Failure (STANDUP AHF)

Heart Failure

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial