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Efficacy, Safety and Tolerability of Sexelaxin When Added to Standard Therapy in AHF (RELAX-AHF-ASIA)

Primary Purpose

Acute Heart Failure

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Serelaxin

Placebo

Standard of CareTherapy

About this trial

This is an interventional treatment trial for Acute Heart Failure focused on measuring Serelaxin,, WHF,, Likert Scale,, RELAX-AHF-ASIA,, RLX030,, AHF,, acute heart failure

Eligibility Criteria

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

Inclusion Criteria:

Male or female ≥ 18 years of age, with body weight ≤160 kg
Hospitalized for AHF; AHF is defined as including all of the following measured at any time between presentation (including the emergency department and outpatient clinic) and at the end of screening:
- Persistent dyspnea at rest or with minimal exertion at screening and at the time of randomization
- Pulmonary congestion on chest radiograph
- Brain natriuretic peptide (BNP) ≥500 pg/mL or NT-proBNP ≥2,000 pg/mL
Systolic BP ≥125 mmHg at the start and at the end of screening
Able to be randomized within 16 hours from presentation to the hospital, including the emergency department and outpatient clinic
Received intravenous furosemide of at least 40 mg total (or equivalent) at any time between presentation (this includes outpatient clinic, ambulance, or hospital including emergency department) and the start of screening for the study for the treatment of the current acute HF episode
Renal impairment defined as an estimate glomerular filtration rate using the between presentation and randomization of ≥ 25 and ≤75mL/min/1.73m2, calculated using the Modification of Diet in Renal Disease formula (or modified sMDRD formula according to specific ethnic groups and local practice guidelines).

Exclusion Criteria:

Dyspnea primarily due to non-cardiac causes
Temperature >38.5°C (oral or equivalent), sepsis, active and clinically significant infection requiring IV anti-microbial treatment or known presence or evidence of Human Immunodeficiency Virus (HIV) infection (based on history and/or clinical findings, including laboratory results obtained during screening period).
Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment
*Patients with systolic blood pressure >180 mmHg at the end of screening
AHF due to significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate <45 beats per minute, or atrial fibrillation/flutter with sustained ventricular response of >130 beats per minute
Hepatic disease unrelated to Heart Failure etiology and as determined by any one of the following: AST and/or ALT values exceeding 3 X ULN and/or bilirubin > 1.5 X ULN at screening or history of hepatic encephalopathy, esophageal varices, or portacaval shunt, or a diagnosis of cirrhosis by any means, or evidence of chronic Hepatitis B (presence of hepatitis B surface antigen production: positive HBsAg), or chronic Hepatitis C infection (presence of Hepatitis C genetic replication: positive Hepatitis C viral RNA, based on history and/or clinical findings, including laboratory results obtained during screening period).
*Significant uncorrected left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area <1.0 cm2 or mean gradient >50 mmHg on prior or current echocardiogram), and severe mitral stenosis
History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past year with a life expectancy less than 1 year

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Serelaxin

Arm Description

Patients will receive continuous intravenous infusion of matching placebo serelaxin for 48 hours.

Patients will receive continuous intravenous infusion of serelaxin(30 µg/kg/day) for 48 hours.

Outcomes

Primary Outcome Measures

Percentage of Patients With a Clinical Composite Endpoint of Treatment Success, Treatment Failure, or no Change.

The trichotomous clinical composite endpoint of treatment success, treatment failure, or no change. Treatment success defined as improvement of dyspnea by Likert scale and at least 2 points improvement by at least 2 physician assessed signs and symptoms (orthopnea, rales edema, and jugular venous pulse) at Day 2; treatment failure defined as worsening heart failure, death, or re-hospitalization due to heart failure or renal failure through Day 5; no change defined as neither the criteria for treatment success nor the criteria for treatment failure was met through Day 5.

Secondary Outcome Measures

Time to WHF

Results are given in terms of number of participants with at least one worsening heart failure (WHF) event through day 5 (pre-defined timeframe).

Time to CV Death

analysis of time to CEC CV death through day 180 : results are given in terms of number of participants with CV death event through day 180 (pre-defined timeframe).

Time to All-cause Death

Results are given in terms of number of participants with all cause death event through day 180 (pre-defined timeframe).

Time to Moderate or Marked Improvements in Dyspnea by Likert Scale, Expressed in Days

Time to event is computed as the number of days from randomization to moderate or marked improvements in dyspnea by Likert scale

Dyspnea by VAS-AUC Changes

Change from baseline in Dyspena by VAS-AUC through Day 5, expressed in mm-hours

Length of Intensive Care Unit (ICU) and/or Coronary Care Unit (CCU) Stay for the Index AHF Hospitalization

Length of stay will be defined as the hospitalization discharge date and the time minus the baseline date and time plus 1 day

Renal Dysfunction and Prevention of Worsening of Renal Function

number of participants with renal dysfunction or in-hospital worsening of renal function through Day 5

Time to Re-hospitalization Due to Heart Failure and Renal Impairment

Time to event is computed as the number of days from randomization to re-hospitalization due to Heart Failure and renal impairment

Time to CV Death or Re-hospitalization Due to Heart Failure/ Renal Failure

Results are given in terms of number of participants with CV death or at least one re-hospitalization due to Heart Failure through day 180 (pre-defined timeframe).

Time to In-hospital Worsening Heart Failure Through Day 5

Results are given in terms of number of participants with at least one in-hospital worsening heart failure through day 5 (pre-defined timeframe). In-hospital worsening heart failure is defined by symptoms only, signs only, and both symptoms and signs.

Use of Loop Diuretic and Vasoactive Agents

Number of patients reported with use of loop diuretic and vasoactive agents from randomization through Day 5

Change From Baseline in Cardio-renal Biomarkers

Number of Patients Reported With Total Adverse Events, Serious Adverse Events and Death.

To evaluate the safety and tolerability of intravenous serelaxin in AHF patients, number of patients with total adverse events, serious adverse events and death will be analyzed.

Full Information

NCT ID

NCT02007720

First Posted

November 20, 2013

Last Updated

June 12, 2019

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02007720

Brief Title

Efficacy, Safety and Tolerability of Sexelaxin When Added to Standard Therapy in AHF

Acronym

RELAX-AHF-ASIA

Official Title

A Multicenter, Randomized, Double-blind, Placebo Controlled Phase III Study to Evaluate the Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in Acute Heart Failure Patients

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Terminated

Why Stopped

Study was terminated based on results from pivotal adult AHF study CRLX030A2301

Study Start Date

March 12, 2014 (Actual)

Primary Completion Date

March 27, 2017 (Actual)

Study Completion Date

June 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of the study was to evaluate the efficacy, safety and tolerability of intravenous infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF) patients.

6. Conditions and Keywords

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

Acute Heart Failure

Keywords

Serelaxin,, WHF,, Likert Scale,, RELAX-AHF-ASIA,, RLX030,, AHF,, acute heart failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

876 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Patients will receive continuous intravenous infusion of matching placebo serelaxin for 48 hours.

Arm Title

Serelaxin

Arm Type

Experimental

Arm Description

Patients will receive continuous intravenous infusion of serelaxin(30 µg/kg/day) for 48 hours.

Intervention Type

Drug

Intervention Name(s)

Serelaxin

Intervention Description

Intravenous infusion

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Intravenous infusion

Intervention Type

Other

Intervention Name(s)

Standard of CareTherapy

Intervention Description

This treatment can include but is not limited to intravenous and/or oral diuretics, ACE inhibitors/angiotensin receptor antagonists, β blockers, and aldosterone receptor antagonists, etc.

Primary Outcome Measure Information:

Title

Percentage of Patients With a Clinical Composite Endpoint of Treatment Success, Treatment Failure, or no Change.

Description

Time Frame

through day 5

Secondary Outcome Measure Information:

Title

Time to WHF

Description

Results are given in terms of number of participants with at least one worsening heart failure (WHF) event through day 5 (pre-defined timeframe).

Time Frame

Through Day 5

Title

Time to CV Death

Description

analysis of time to CEC CV death through day 180 : results are given in terms of number of participants with CV death event through day 180 (pre-defined timeframe).

Time Frame

Through Day 180

Title

Time to All-cause Death

Description

Results are given in terms of number of participants with all cause death event through day 180 (pre-defined timeframe).

Time Frame

Through Day 180

Title

Time to Moderate or Marked Improvements in Dyspnea by Likert Scale, Expressed in Days

Description

Time to event is computed as the number of days from randomization to moderate or marked improvements in dyspnea by Likert scale

Time Frame

Through Day 5

Title

Dyspnea by VAS-AUC Changes

Description

Change from baseline in Dyspena by VAS-AUC through Day 5, expressed in mm-hours

Time Frame

Through Day 5

Title

Length of Intensive Care Unit (ICU) and/or Coronary Care Unit (CCU) Stay for the Index AHF Hospitalization

Description

Length of stay will be defined as the hospitalization discharge date and the time minus the baseline date and time plus 1 day

Time Frame

Up to day 30

Title

Renal Dysfunction and Prevention of Worsening of Renal Function

Description

number of participants with renal dysfunction or in-hospital worsening of renal function through Day 5

Time Frame

Through Day 5

Title

Time to Re-hospitalization Due to Heart Failure and Renal Impairment

Description

Time to event is computed as the number of days from randomization to re-hospitalization due to Heart Failure and renal impairment

Time Frame

Through Day 180

Title

Time to CV Death or Re-hospitalization Due to Heart Failure/ Renal Failure

Description

Results are given in terms of number of participants with CV death or at least one re-hospitalization due to Heart Failure through day 180 (pre-defined timeframe).

Time Frame

Through Day 180

Title

Time to In-hospital Worsening Heart Failure Through Day 5

Description

Time Frame

Through Day 5

Title

Use of Loop Diuretic and Vasoactive Agents

Description

Number of patients reported with use of loop diuretic and vasoactive agents from randomization through Day 5

Time Frame

Through Day 5

Title

Change From Baseline in Cardio-renal Biomarkers

Time Frame

Day 2 and Day 5

Title

Number of Patients Reported With Total Adverse Events, Serious Adverse Events and Death.

Description

To evaluate the safety and tolerability of intravenous serelaxin in AHF patients, number of patients with total adverse events, serious adverse events and death will be analyzed.

Time Frame

For the safety evaluation, all adverse events will be collected from signing of the informed consent form through Day 5 for non-serious AEs and through Day 14 for serious AEs.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female ≥ 18 years of age, with body weight ≤160 kg Hospitalized for AHF; AHF is defined as including all of the following measured at any time between presentation (including the emergency department and outpatient clinic) and at the end of screening: Persistent dyspnea at rest or with minimal exertion at screening and at the time of randomization Pulmonary congestion on chest radiograph Brain natriuretic peptide (BNP) ≥500 pg/mL or NT-proBNP ≥2,000 pg/mL Systolic BP ≥125 mmHg at the start and at the end of screening Able to be randomized within 16 hours from presentation to the hospital, including the emergency department and outpatient clinic Received intravenous furosemide of at least 40 mg total (or equivalent) at any time between presentation (this includes outpatient clinic, ambulance, or hospital including emergency department) and the start of screening for the study for the treatment of the current acute HF episode Renal impairment defined as an estimate glomerular filtration rate using the between presentation and randomization of ≥ 25 and ≤75mL/min/1.73m2, calculated using the Modification of Diet in Renal Disease formula (or modified sMDRD formula according to specific ethnic groups and local practice guidelines). Exclusion Criteria: Dyspnea primarily due to non-cardiac causes Temperature >38.5°C (oral or equivalent), sepsis, active and clinically significant infection requiring IV anti-microbial treatment or known presence or evidence of Human Immunodeficiency Virus (HIV) infection (based on history and/or clinical findings, including laboratory results obtained during screening period). Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment *Patients with systolic blood pressure >180 mmHg at the end of screening AHF due to significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate <45 beats per minute, or atrial fibrillation/flutter with sustained ventricular response of >130 beats per minute Hepatic disease unrelated to Heart Failure etiology and as determined by any one of the following: AST and/or ALT values exceeding 3 X ULN and/or bilirubin > 1.5 X ULN at screening or history of hepatic encephalopathy, esophageal varices, or portacaval shunt, or a diagnosis of cirrhosis by any means, or evidence of chronic Hepatitis B (presence of hepatitis B surface antigen production: positive HBsAg), or chronic Hepatitis C infection (presence of Hepatitis C genetic replication: positive Hepatitis C viral RNA, based on history and/or clinical findings, including laboratory results obtained during screening period). *Significant uncorrected left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area <1.0 cm2 or mean gradient >50 mmHg on prior or current echocardiogram), and severe mitral stenosis History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past year with a life expectancy less than 1 year

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100037

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100039

Country

China

Facility Name

Novartis Investigative Site

City

Lanzhou

State/Province

Gansu

ZIP/Postal Code

730030

Country

China

Facility Name

Novartis Investigative Site

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

51000

Country

China

Facility Name

Novartis Investigative Site

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510515

Country

China

Facility Name

Novartis Investigative Site

City

Suzhou

State/Province

Jiangsu

ZIP/Postal Code

215006

Country

China

Facility Name

Novartis Investigative Site

City

Yangzhou

State/Province

Jiangsu

Country

China

Facility Name

Novartis Investigative Site

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110000

Country

China

Facility Name

Novartis Investigative Site

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110003

Country

China

Facility Name

Novartis Investigative Site

City

Jinshan

State/Province

Shanghai

ZIP/Postal Code

201508

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

Novartis Investigative Site

City

Xian

State/Province

Shanxi

ZIP/Postal Code

710061

Country

China

Facility Name

Novartis Investigative Site

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300121

Country

China

Facility Name

Novartis Investigative Site

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310013

Country

China

Facility Name

Novartis Investigative Site

City

Wenzhou

State/Province

Zhejiang

ZIP/Postal Code

325000

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100050

Country

China

Facility Name

Novartis Investigative Site

City

Chongqing

ZIP/Postal Code

400037

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai City

Country

China

Facility Name

Novartis Investigative Site

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110029

Country

India

Facility Name

Novartis Investigative Site

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380054

Country

India

Facility Name

Novartis Investigative Site

City

Vadodara

State/Province

Gujarat

ZIP/Postal Code

390022

Country

India

Facility Name

Novartis Investigative Site

City

Nagpur

State/Province

Maharashtra

ZIP/Postal Code

440010

Country

India

Facility Name

Novartis Investigative Site

City

Nagpur

State/Province

Maharashtra

ZIP/Postal Code

440012

Country

India

Facility Name

Novartis Investigative Site

City

Chennai

State/Province

Tamil Nadu

ZIP/Postal Code

600101

Country

India

Facility Name

Novartis Investigative Site

City

Hyderabad

State/Province

Telangana

ZIP/Postal Code

500082

Country

India

Facility Name

Novartis Investigative Site

City

Rajasthan

ZIP/Postal Code

334003

Country

India

Facility Name

Novartis Investigative Site

City

Nagakute-city

State/Province

Aichi

ZIP/Postal Code

480-1195

Country

Japan

Facility Name

Novartis Investigative Site

City

Seto-city

State/Province

Aichi

ZIP/Postal Code

489-8642

Country

Japan

Facility Name

Novartis Investigative Site

City

Kamogawa-city

State/Province

Chiba

ZIP/Postal Code

2968602

Country

Japan

Facility Name

Novartis Investigative Site

City

Saijo-city

State/Province

Ehime

ZIP/Postal Code

793-0027

Country

Japan

Facility Name

Novartis Investigative Site

City

Chikushino-city

State/Province

Fukuka

ZIP/Postal Code

818-8516

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukuoka-city

State/Province

Fukuoka

ZIP/Postal Code

810-0001

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukuoka-city

State/Province

Fukuoka

ZIP/Postal Code

811-0213

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukuoka-city

State/Province

Fukuoka

ZIP/Postal Code

815-8588

Country

Japan

Facility Name

Novartis Investigative Site

City

Iizuka-city

State/Province

Fukuoka

ZIP/Postal Code

820-8505

Country

Japan

Facility Name

Novartis Investigative Site

City

Kurume-city

State/Province

Fukuoka

ZIP/Postal Code

830-8543

Country

Japan

Facility Name

Novartis Investigative Site

City

Kurume-city

State/Province

Fukuoka

ZIP/Postal Code

830-8577

Country

Japan

Facility Name

Novartis Investigative Site

City

Ogaki-city

State/Province

Gifu

ZIP/Postal Code

503-8502

Country

Japan

Facility Name

Novartis Investigative Site

City

Kushiro-city

State/Province

Hokkaido

ZIP/Postal Code

085-0062

Country

Japan

Facility Name

Novartis Investigative Site

City

Sapporo-city

State/Province

Hokkaido

ZIP/Postal Code

006-8555

Country

Japan

Facility Name

Novartis Investigative Site

City

Amagasaki city

State/Province

Hyogo

ZIP/Postal Code

660 8550

Country

Japan

Facility Name

Novartis Investigative Site

City

Kobe-City

State/Province

Hyogo

ZIP/Postal Code

654-0155

Country

Japan

Facility Name

Novartis Investigative Site

City

Mito-city

State/Province

Ibaraki

ZIP/Postal Code

311-4198

Country

Japan

Facility Name

Novartis Investigative Site

City

Kanazawa

State/Province

Ishikawa

ZIP/Postal Code

920 8650

Country

Japan

Facility Name

Novartis Investigative Site

City

Kanonji-city

State/Province

Kagawa

ZIP/Postal Code

769-1695

Country

Japan

Facility Name

Novartis Investigative Site

City

Takamatsu city

State/Province

Kagawa

ZIP/Postal Code

760 8557

Country

Japan

Facility Name

Novartis Investigative Site

City

Kawasaki-city

State/Province

Kanagawa

ZIP/Postal Code

211-8533

Country

Japan

Facility Name

Novartis Investigative Site

City

Yokohama city

State/Province

Kanagawa

ZIP/Postal Code

232 0024

Country

Japan

Facility Name

Novartis Investigative Site

City

Yokohama-city

State/Province

Kanagawa

ZIP/Postal Code

227-8501

Country

Japan

Facility Name

Novartis Investigative Site

City

Yokohama-city

State/Province

Kanagawa

ZIP/Postal Code

231-8682

Country

Japan

Facility Name

Novartis Investigative Site

City

Yokohama-city

State/Province

Kanagawa

ZIP/Postal Code

236 0051

Country

Japan

Facility Name

Novartis Investigative Site

City

Kochi city

State/Province

Kochi

ZIP/Postal Code

781 8555

Country

Japan

Facility Name

Novartis Investigative Site

City

Kumamoto-city

State/Province

Kumamoto

ZIP/Postal Code

861-4193

Country

Japan

Facility Name

Novartis Investigative Site

City

Yatsushiro-city

State/Province

Kumamoto

ZIP/Postal Code

866-8660

Country

Japan

Facility Name

Novartis Investigative Site

City

Kyoto-city

State/Province

Kyoto

ZIP/Postal Code

607-8062

Country

Japan

Facility Name

Novartis Investigative Site

City

Uji-city

State/Province

Kyoto

ZIP/Postal Code

611-0042

Country

Japan

Facility Name

Novartis Investigative Site

City

Sendai-city

State/Province

Miyagi

ZIP/Postal Code

981-3133

Country

Japan

Facility Name

Novartis Investigative Site

City

Nakano-city

State/Province

Nagano

ZIP/Postal Code

383-8505

Country

Japan

Facility Name

Novartis Investigative Site

City

Saku-city

State/Province

Nagano

ZIP/Postal Code

3850051

Country

Japan

Facility Name

Novartis Investigative Site

City

Ueda-city

State/Province

Nagano

ZIP/Postal Code

386-8610

Country

Japan

Facility Name

Novartis Investigative Site

City

Niigata-city

State/Province

Niigata

ZIP/Postal Code

950-1197

Country

Japan

Facility Name

Novartis Investigative Site

City

Osaka-city

State/Province

Osaka

ZIP/Postal Code

540-0006

Country

Japan

Facility Name

Novartis Investigative Site

City

Kawaguchi-city

State/Province

Saitama

ZIP/Postal Code

333-0842

Country

Japan

Facility Name

Novartis Investigative Site

City

Sayama-city

State/Province

Saitama

ZIP/Postal Code

350-1323

Country

Japan

Facility Name

Novartis Investigative Site

City

Wako-city

State/Province

Saitama

ZIP/Postal Code

351-0102

Country

Japan

Facility Name

Novartis Investigative Site

City

Kusatsu city

State/Province

Shiga

ZIP/Postal Code

525 8585

Country

Japan

Facility Name

Novartis Investigative Site

City

Hamamatsu-city

State/Province

Shizuoka

ZIP/Postal Code

430-8558

Country

Japan

Facility Name

Novartis Investigative Site

City

Kakegawa-city

State/Province

Shizuoka

ZIP/Postal Code

436-8555

Country

Japan

Facility Name

Novartis Investigative Site

City

Akishima-city

State/Province

Tokyo

ZIP/Postal Code

196-0003

Country

Japan

Facility Name

Novartis Investigative Site

City

Chuo ku

State/Province

Tokyo

ZIP/Postal Code

104-8560

Country

Japan

Facility Name

Novartis Investigative Site

City

Hachioji-city

State/Province

Tokyo

ZIP/Postal Code

192-0918

Country

Japan

Facility Name

Novartis Investigative Site

City

Itabashi-ku

State/Province

Tokyo

ZIP/Postal Code

173-8610

Country

Japan

Facility Name

Novartis Investigative Site

City

Musashino-city

State/Province

Tokyo

ZIP/Postal Code

180-8610

Country

Japan

Facility Name

Novartis Investigative Site

City

Shinagawa ku

State/Province

Tokyo

ZIP/Postal Code

141 8625

Country

Japan

Facility Name

Novartis Investigative Site

City

Shinagawa-ku

State/Province

Tokyo

ZIP/Postal Code

142-8666

Country

Japan

Facility Name

Novartis Investigative Site

City

Tanabe-city

State/Province

Wakayama

ZIP/Postal Code

646-8558

Country

Japan

Facility Name

Novartis Investigative Site

City

Osaka

ZIP/Postal Code

534-0021

Country

Japan

Facility Name

Novartis Investigative Site

City

Saitama

ZIP/Postal Code

330 8503

Country

Japan

Facility Name

Novartis Investigative Site

City

Amman

State/Province

JOR

ZIP/Postal Code

11152

Country

Jordan

Facility Name

Novartis Investigative Site

City

Amman

ZIP/Postal Code

11183

Country

Jordan

Facility Name

Novartis Investigative Site

City

Amman

ZIP/Postal Code

11184

Country

Jordan

Facility Name

Novartis Investigative Site

City

Gyeonggi do

State/Province

Bucheon Si

ZIP/Postal Code

422-711

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Cheongju si

State/Province

Chungcheongbuk Do

ZIP/Postal Code

28644

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Wonju

State/Province

Gangwon-do

ZIP/Postal Code

26427

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Bundang Gu

State/Province

Gyeonggi Do

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

08308

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Seocho Gu

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Busan

ZIP/Postal Code

602739

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Gwangju

ZIP/Postal Code

61469

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Incheon

ZIP/Postal Code

405 760

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

02841

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Ashrafieh

ZIP/Postal Code

166830

Country

Lebanon

Facility Name

Novartis Investigative Site

City

Beirut

ZIP/Postal Code

1107 2020

Country

Lebanon

Facility Name

Novartis Investigative Site

City

Beirut

Country

Lebanon

Facility Name

Novartis Investigative Site

City

Hazmieh

ZIP/Postal Code

470

Country

Lebanon

Facility Name

Novartis Investigative Site

City

Kuala Lumpur

State/Province

MYS

ZIP/Postal Code

56000

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Kota Kinabalu

State/Province

Sabah

ZIP/Postal Code

88300

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Kuching

State/Province

Sarawak

ZIP/Postal Code

94300

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Kuala Lumpur

State/Province

Selangor Darul Ehsan

ZIP/Postal Code

43000

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Sungai Buloh

State/Province

Selangor Darul Ehsan

ZIP/Postal Code

47000

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Kuala Lumpur

ZIP/Postal Code

50400

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Kuala Lumpur

ZIP/Postal Code

59100

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Quezon City

State/Province

Manila

ZIP/Postal Code

1100

Country

Philippines

Facility Name

Novartis Investigative Site

City

Manila

State/Province

Metro Manila

ZIP/Postal Code

1000

Country

Philippines

Facility Name

Novartis Investigative Site

City

Makati City

ZIP/Postal Code

1229

Country

Philippines

Facility Name

Novartis Investigative Site

City

Manila

ZIP/Postal Code

1003

Country

Philippines

Facility Name

Novartis Investigative Site

City

Pasig City

ZIP/Postal Code

1605

Country

Philippines

Facility Name

Novartis Investigative Site

City

Quezon City

ZIP/Postal Code

1102

Country

Philippines

Facility Name

Novartis Investigative Site

City

Quezon City

ZIP/Postal Code

1113

Country

Philippines

Facility Name

Novartis Investigative Site

City

San Juan City

ZIP/Postal Code

1500

Country

Philippines

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

117549

Country

Singapore

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

169609

Country

Singapore

Facility Name

Novartis Investigative Site

City

Changhua

ZIP/Postal Code

50006

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Kaohsiung City

ZIP/Postal Code

83301

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Kaohsiung

ZIP/Postal Code

80756

Country

Taiwan

Facility Name

Novartis Investigative Site

City

New Taipei

ZIP/Postal Code

22060

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

10449

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taoyuan

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Yilan

ZIP/Postal Code

26058

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Songkhla

State/Province

Hat Yai

ZIP/Postal Code

90110

Country

Thailand

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Novartis Investigative Site

City

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

Facility Name

Novartis Investigative Site

City

Muang

ZIP/Postal Code

40002

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

35184572

Citation

Grand J, Miger K, Sajadieh A, Kober L, Torp-Pedersen C, Ertl G, Lopez-Sendon J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Blood Pressure Drops During Hospitalization for Acute Heart Failure Treated With Serelaxin: A Patient-Level Analysis of 4 Randomized Controlled Trials. Circ Heart Fail. 2022 Apr;15(4):e009199. doi: 10.1161/CIRCHEARTFAILURE.121.009199. Epub 2022 Feb 21.

Results Reference

derived

PubMed Identifier

34514815

Citation

Grand J, Miger K, Sajadieh A, Kober L, Torp-Pedersen C, Ertl G, Lopez-Sendon J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Systolic Blood Pressure and Outcome in Patients Admitted With Acute Heart Failure: An Analysis of Individual Patient Data From 4 Randomized Clinical Trials. J Am Heart Assoc. 2021 Sep 21;10(18):e022288. doi: 10.1161/JAHA.121.022288. Epub 2021 Sep 13.

Results Reference

derived

Learn more about this trial

Efficacy, Safety and Tolerability of Sexelaxin When Added to Standard Therapy in AHF

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Efficacy, Safety and Tolerability of Sexelaxin When Added to Standard Therapy in AHF (RELAX-AHF-ASIA)

Acute Heart Failure

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

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