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A Study of Mavacamten in Participants With HFpEF and Elevation of NT-proBNP With or Without Elevation of cTnT | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of Mavacamten in Participants With HFpEF and Elevation of NT-proBNP With or Without Elevation of cTnT

An Exploratory, Open-label, Proof-of-concept, Phase 2a Study of Mavacamten (MYK-461) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Chronic Elevation of Cardiac Biomarkers

NCT04766892•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

This is a Phase 2a proof-of-concept study to assess safety, tolerability, and preliminary efficacy of mavacamten treatment on biomarker levels in participants with heart failure with preserved ejection fraction (HFpEF) and elevation of NT-proBNP with or without elevation of cTnT. Data from this study will inform future study designs of mavacamten in patients with HFpEF.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Is at least 50 years old at Screening.
•2. Body weight is greater than 45 kg at Screening.
•3. Documented prior objective evidence of heart failure as shown by 1 or more of the following criteria:
•* Previous hospitalization for heart failure with documented radiographic evidence of pulmonary congestion.
•* Elevated LV end-diastolic pressure or pulmonary capillary wedge pressure at rest (≥15 mm Hg) or with exercise (≥25 mm Hg).
•* Elevated level of NT-proBNP (\>400 pg/mL) or brain natriuretic peptide (BNP) (\>200 pg/mL).
•* Echocardiographic evidence of medial E/e' ratio ≥ 15 or left atrial enlargement (left atrial volume index \>34 mL/m2) together with chronic treatment with spironolactone, eplerenone, or a loop diuretic.
•4. Meets 1 or more of the following criteria:
•1. A screening hs-cTnT ≥ 99th percentile AND a screening NT-proBNP \> 200 pg/mL (if not in atrial fibrillation or atrial flutter) or \> 500 pg/mL (if in atrial fibrillation or atrial flutter) OR if the screened participant is of African descent or has a body mass index (BMI) ≥ 30.0 kg/m2, a screening hs-cTnT ≥ 99th percentile, AND a screening NT-proBNP \> 160 pg/mL (if not in atrial fibrillation or atrial flutter) or \> 400 pg/mL (if in atrial fibrillation or atrial flutter).
•2. A screening NT-proBNP \> 300 pg/mL (if not in atrial fibrillation or atrial flutter) or \> 750 pg/mL (if in atrial fibrillation or atrial flutter) OR if the screened participant is of African descent or has a BMI ≥ 30.0 kg/m2, a screening NT-proBNP \> 240 pg/mL (if not in atrial fibrillation or atrial flutter) or \> 600 pg/mL (if in atrial fibrillation or atrial flutter).
+4 more criteria

Exclusion Criteria

•1. Has a prior diagnosis of HCM OR a known infiltrative or storage disorder causing HFpEF and/or cardiac hypertrophy, such as amyloidosis, Fabry disease, or Noonan syndrome with LV hypertrophy OR a positive serum immunofixation result.
•2. Has a history of syncope within the last 6 months or sustained ventricular tachycardia with exercise within the past 6 months.
•3. Has a history of resuscitated sudden cardiac arrest at any time or known appropriate implantable cardioverter defibrillator discharge within 6 months prior to Screening.
•4. Has persistent or permanent atrial fibrillation not on anticoagulation for at least 4 weeks prior to Screening and/or is not adequately rate controlled within 6 months prior to Screening.
•5. Currently treated or planned treatment during the study with either: (a) a combination of beta blocker and verapamil or a combination of beta blocker and diltiazem, (b) disopyramide, or (c) biotin or biotin-containing supplements/multivitamins.
•6. Has known moderate or severe aortic valve stenosis, hemodynamically significant mitral stenosis, or severe mitral or tricuspid regurgitation at Screening.
•7. Has severe chronic obstructive pulmonary disease, or other severe pulmonary disease, requiring home oxygen, chronic nebulizer therapy, chronic oral steroid therapy or hospitalized for pulmonary decompensation within 12 months.
•8. Has body mass index ≥45.0 kg/m2.
•9. Has left ventricular global longitudinal strain by TTE in the range from 0 to -12.0 (assessed by the central laboratory).
•10. Has NT-proBNP at Screening \>2000 pg/mL.
+1 more criteria

Locations (21)

Local Institution - 0028

Birmingham, Alabama, United States

Local Institution - 0019

Phoenix, Arizona, United States

Local Institution - 0011

Tucson, Arizona, United States

Local Institution - 0005

Los Angeles, California, United States

Local Institution - 0026

San Francisco, California, United States

Local Institution - 0020

Jacksonville, Florida, United States

Local Institution - 0014

Miami, Florida, United States

Local Institution - 0018

Atlanta, Georgia, United States

Local Institution - 0004

Chicago, Illinois, United States

Local Institution - 0023

Hazel Crest, Illinois, United States

Key Dates

Start Date

March 30, 2021

Primary Completion Date

February 26, 2024

Completion Date

February 26, 2024

Last Updated

March 20, 2025

Enrollment

ACTUAL participants

Conditions

Heart Failure With Preserved Ejection Fraction

Interventions

mavacamten

DRUG

Prospective Evaluation of AI-ECG for SHD Detection

NCT07057466

Valvular Heart Disease Stenosis and Regurgitation (Diagnosis)Pulmonary Hypertension (Diagnosis)+2 more

View study

RECRUITING

A Study Of CS Reducer For Symptomatic Heart Failure With HFpEF And CMD

NCT07093528

Heart Failure With Preserved Ejection FractionCoronary Microvascular Dysfunction

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Mavacamten in Participants With HFpEF and Elevation of NT-proBNP With or Without Elevation of cTnT

Inclusion Criteria

Exclusion Criteria

Prospective Evaluation of AI-ECG for SHD Detection

A Study Of CS Reducer For Symptomatic Heart Failure With HFpEF And CMD

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Treating Atrial Fibrillation in Heart Failure With Preserved Ejection Fraction: Ablation or Medication

Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction

Assessment of CCM in HF With Higher Ejection Fraction