Log In to Bolder Science

Don't have an account? Sign Up


Please enter your email address.

You will receive a link to create a new password via email.

Log In


Create an Account

  • 8 characters minimum
  • First character may not be a number
  • Last character may not be a number

By completing and submitting this form, you agree to allow Bolder Science to collect the information provided and to receive communications from Bolder Science in the future regarding disease education and research updates.


Welcome and thank you for creating an account!

At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

Condition Categories

Condition categories are pulled directly from Choose 1 or more condition categories that you are interested in:

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

Set a default location

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

  • identifier


  • Recruitment Status


  • First Posted

    February 23, 2021

  • Last update posted

    September 8, 2022

Study Description

Brief 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.

  • Condition or Disease:Heart Failure With Preserved Ejection Fraction
  • Intervention/Treatment: Drug: mavacamten
  • Phase: Phase 2

Detailed Description


Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 35 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Study of Mavacamten in Participants With HFpEF and Elevation of NT-proBNP With or Without Elevation of cTnT
  • Actual Study Start Date: March 2021
  • Estimated Primary Completion Date: April 2023
  • Estimated Study Completion Date: April 2023

Arms and interventions

Arm Intervention/treatment
Experimental: mavacamten (MYK-461)
Drug: mavacamten
mavacamten capsules

Outcome Measures

  • Primary Outcome Measures: 1. Frequency and severity of treatment-emergent adverse events, adverse events of special interest, and serious adverse events. [ Time Frame: 26 weeks ]
  • 2. Mavacamten effect on NT-proBNP levels (at rest) [ Time Frame: 26 weeks ]
    Specifically, change from baseline to Week 26 in NT-proBNP (resting)
  • 3. Mavacamten effect on cTnT levels (at rest) [ Time Frame: 26 weeks ]
    Specifically, change from baseline to Week 26 in cTnT (resting), as assessed by a high-sensitivity assay

Eligibility Criteria

  • Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No


Key Inclusion Criteria: Is at least 50 years old at Screening. Body weight is greater than 45 kg at Screening. 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. Meets 1 or more of the following criteria: 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). 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). Has documented LVEF ≥60% at the Screening visit and no history of prior LVEF ≤ 45%. Has maximal left ventricular wall thickness ≥12 mm OR documented elevated left ventricular mass index by 2-dimensional imaging (>95 g/m2 if female and >115 g/m2 if male). Has high quality TTEs without or with echocardiographic contrast agents. Has NYHA class II or III symptoms at Screening. Key Exclusion Criteria: 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. Has a history of syncope within the last 6 months or sustained ventricular tachycardia with exercise within the past 6 months. Has a history of resuscitated sudden cardiac arrest at any time or known appropriate implantable cardioverter defibrillator discharge within 6 months prior to Screening. 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. 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. Has known moderate or severe aortic valve stenosis, hemodynamically significant mitral stenosis, or severe mitral or tricuspid regurgitation at Screening. 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. Has body mass index ≥45.0 kg/m2. Has left ventricular global longitudinal strain by TTE in the range from 0 to -12.0 (assessed by the central laboratory). Has NT-proBNP at Screening >2000 pg/mL. Has acute decompensated heart failure events requiring intravenous (IV) diuretics, IV inotropes, IV vasodilators, or a left ventricular assist device within 30 days prior to Screening.

Contacts and Locations


Contact: BMS Study Connect Contact Center 855-907-3286

Contact: First line of the email MUST contain NCT # and Site #.


United States, Arizona
Arizona Center For Clinical Research

United States, Arizona
Southern Arizona Va Health Care System

United States, California
University Of California - San Diego Medical Center
La Jolla

United States, California
Cedars-Sinai Medical Center
Los Angeles

United States, California
Local Institution - 0029

United States, Florida
Jacksonville Center For Clinical Research

United States, Florida
Infinite Clinical Research

United States, Georgia
Emory University School Of Medicine

United States, Illinois
Northwestern University

United States, Illinois
Local Institution

United States, Illinois
Chicago Medical Research
Hazel Crest

United States, Indiana
Local Institution - 0021

United States, Louisiana
Louisiana Heart Center

United States, Michigan
Spectrum Health Hospitals
Grand Rapids

United States, New York
Weill Cornell Medical Center
New York

United States, North Carolina
Duke University Medical Center

United States, Ohio
Local Institution - 0015

United States, Oklahoma
South Oklahoma Heart Research
Oklahoma City

United States, Oregon
Providence St. Vincent Medical Center

United States, Oregon
Oregon Health & Science University

United States, Pennsylvania
University of Pennsylvania

United States, South Carolina
Medical University of South Carolina

United States, Tennessee
Stern Cardiovascular Foundation Inc

United States, Utah
University of Utah
Salt Lake City

Canada, Ontario
Hamilton General Hospital

Canada, Ontario
Women's College Hospital

Canada, Quebec
Institut de Cardiologie de Montreal

Canada, Quebec
Ciusss McQ

St Michaels Hospital

Sponsors and Collaborators

Bristol-Myers Squibb


Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • Identifier: NCT04766892 History of Changes
  • Other Study ID Numbers: CV027-005
  • First Posted: February 23, 2021 Key Record Dates
  • Last Update Posted: September 8, 2022
  • Last Verified: September 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: HFpEF
    Cardiac troponin T
  • Additional relevant MeSH terms: Heart Failure
    Heart Diseases
    Cardiovascular Diseases