Back to results

A Study Evaluating Biomarkers in Participants With Heart Failure (MK-0000-344)

Primary Purpose

Heart Failure

Status

Withdrawn

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Blood Draw

Loop Diuretic Withdrawal/Salt Load

About this trial

This is an interventional diagnostic trial for Heart Failure

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

female of reproductive potential must demonstrate non-pregnant state, and agree to use two acceptable methods of birth control
postmenopausal or surgically sterile female
have a Body Mass Index (BMI) >= 18 and =< 35 kg/m^2, inclusive
healthy participants are in general good health
participants with HF have no untreated, significant health issue from other co-morbidities, e.g. uncontrolled hypertension
is willing to undergo echocardiography, CMR, and other study assessments
participants with HF have a diagnosis of cardiomyopathy, and slight to moderate limitation of physical activity, but are comfortable at rest
participants with HF are on a stable medical therapy for HF for two weeks prior to start of Part 1
participants with HF are on a stable diuretic regimen of >= 40 mg/day furosemide or >= 10 mg/day torsemide for at least 2 weeks prior to start of Part 1

Exclusion Criteria:

has any clinically significant, uncontrolled renal, endocrine (except Type II Diabetes), neurological, hepatic, immunological or inflammatory disease
has a history of cancer (malignancy)
had major surgery or donated/lost approximately 500 mL of blood within 4 weeks prior to screening
participated in another investigational trial within 4 weeks prior to screening
excepting permitted medications, uses prescription, or non-prescription drugs or herbal remedies 2 weeks prior to enrollment until completion of trial
takes medications that affect BNP levels within 30 days prior to screening
undergoes high-intensity physical exercise from 1 week prior to pretrial visit until completion of trial
has implanted or embedded metal objects in body that in response to a magnetic field could cause injury
suffers from claustrophobia making them unable to undergo CMR scanning
consumes alcohol for 7 days prior to screening until completion of study
consumes excessive amounts of caffeinated beverages
uses cannabis regularly, or any illicit drugs, or has a history of drug (including alcohol) abuse within prior 12 months

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Healthy

Mild/moderate heart failure (HF)

Severe HF

Arm Description

Part 1: Blood is obtained from healthy participants on 3 consecutive days, and participants undergo Cardiac Magnetic Resonance Imaging (CMR) and two-dimensional speckle tracking echocardiography (2DSTE) on one of those 3 days.

Part 1: Blood is obtained from participants with mild/moderate HF on 3 consecutive days, and participants undergo CMR and 2DSTE on one of those 3 days. Part 2: Within 5 days of completing Part 1 participants have a 24 hour loop diuretic withdrawal, and 15 hour 0.9% normal saline infusion; followed by a blood draw, CMR and 2DSTE.

Part 1: Blood is obtained from participants with severe HF on 3 consecutive days, and participants undergo CMR and 2DSTE on one of those 3 days. Part 2: Within 5 days of completing Part 1 participants have a 24 hour loop diuretic withdrawal, and 15 hour 0.9% normal saline infusion; followed by a blood draw, CMR and 2DSTE.

Outcomes

Primary Outcome Measures

Level of total BNP in Part 1

Level of total BNP in Part 2

Secondary Outcome Measures

Level of active BNP in Part 1

Level of active BNP in Part 2

Ratio of total BNP/active BNP in Part 1

Ratio of total BNP/active BNP in Part 2

Full Information

NCT ID

NCT02364752

First Posted

February 10, 2015

Last Updated

March 10, 2016

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT02364752

Brief Title

A Study Evaluating Biomarkers in Participants With Heart Failure (MK-0000-344)

Official Title

A Clinical Trial to Evaluate Circulating and Imaging Biomarkers in Heart Failure Patients

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Withdrawn

Study Start Date

September 2015 (undefined)

Primary Completion Date

March 2016 (Anticipated)

Study Completion Date

November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this 2-part study is to assess B-type natriuretic peptide (BNP) as well as other circulating and imaging biomarkers in myocardial function. Part 1 assesses biomarker levels in healthy participants and participants with cardiac dysfunction. Part 2 assesses BNP and other circulating biomarker levels, and performs imaging in participants with cardiac dysfunction who continued from Part 1. The primary hypothesis is that compared to healthy participants, biomarker levels are elevated in participants with mild/moderate and severe cardiac dysfunction.

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

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Healthy

Arm Type

Experimental

Arm Description

Arm Title

Mild/moderate heart failure (HF)

Arm Type

Experimental

Arm Description

Arm Title

Severe HF

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Blood Draw

Intervention Type

Procedure

Intervention Name(s)

Loop Diuretic Withdrawal/Salt Load

Primary Outcome Measure Information:

Title

Level of total BNP in Part 1

Time Frame

Up to Day 3

Title

Level of total BNP in Part 2

Time Frame

Up to Day 1 post-loop diuretic withdrawal (Up to Day 10)

Secondary Outcome Measure Information:

Title

Level of active BNP in Part 1

Time Frame

Up to Day 3

Title

Level of active BNP in Part 2

Time Frame

Up to Day 1 post-loop diuretic withdrawal (Up to Day 10)

Title

Ratio of total BNP/active BNP in Part 1

Time Frame

Up to Day 3

Title

Ratio of total BNP/active BNP in Part 2

Time Frame

Up to Day 1 post-loop diuretic withdrawal (Up to Day 10)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: female of reproductive potential must demonstrate non-pregnant state, and agree to use two acceptable methods of birth control postmenopausal or surgically sterile female have a Body Mass Index (BMI) >= 18 and =< 35 kg/m^2, inclusive healthy participants are in general good health participants with HF have no untreated, significant health issue from other co-morbidities, e.g. uncontrolled hypertension is willing to undergo echocardiography, CMR, and other study assessments participants with HF have a diagnosis of cardiomyopathy, and slight to moderate limitation of physical activity, but are comfortable at rest participants with HF are on a stable medical therapy for HF for two weeks prior to start of Part 1 participants with HF are on a stable diuretic regimen of >= 40 mg/day furosemide or >= 10 mg/day torsemide for at least 2 weeks prior to start of Part 1 Exclusion Criteria: has any clinically significant, uncontrolled renal, endocrine (except Type II Diabetes), neurological, hepatic, immunological or inflammatory disease has a history of cancer (malignancy) had major surgery or donated/lost approximately 500 mL of blood within 4 weeks prior to screening participated in another investigational trial within 4 weeks prior to screening excepting permitted medications, uses prescription, or non-prescription drugs or herbal remedies 2 weeks prior to enrollment until completion of trial takes medications that affect BNP levels within 30 days prior to screening undergoes high-intensity physical exercise from 1 week prior to pretrial visit until completion of trial has implanted or embedded metal objects in body that in response to a magnetic field could cause injury suffers from claustrophobia making them unable to undergo CMR scanning consumes alcohol for 7 days prior to screening until completion of study consumes excessive amounts of caffeinated beverages uses cannabis regularly, or any illicit drugs, or has a history of drug (including alcohol) abuse within prior 12 months

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

A Study Evaluating Biomarkers in Participants With Heart Failure (MK-0000-344)

We'll reach out to this number within 24 hrs