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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02364752
• Other study ID #: 0000-344
• Status: Withdrawn
• Phase: Phase 1
• First received: February 10, 2015
• Last updated: March 10, 2016
• Start date: September 2015
• Est. completion date: November 2016

Study information

• Verified date: March 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Heart Failure

Intervention

Procedure:
• Blood Draw

• Loop Diuretic Withdrawal/Salt Load

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of total BNP in Part 1		Up to Day 3	No
Primary	Level of total BNP in Part 2		Up to Day 1 post-loop diuretic withdrawal (Up to Day 10)	No
Secondary	Level of active BNP in Part 1		Up to Day 3	No
Secondary	Level of active BNP in Part 2		Up to Day 1 post-loop diuretic withdrawal (Up to Day 10)	No
Secondary	Ratio of total BNP/active BNP in Part 1		Up to Day 3	No
Secondary	Ratio of total BNP/active BNP in Part 2		Up to Day 1 post-loop diuretic withdrawal (Up to Day 10)	No