A Study Evaluating Biomarkers in Participants With Heart Failure (MK-0000-344)
Heart Failure
About this trial
This is an interventional diagnostic trial for Heart Failure
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Healthy
Mild/moderate heart failure (HF)
Severe HF
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.