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Hypertrophic CardiomyopathyPhase 2/3NCT03723655

A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM

A Phase 2/3 study testing mavacamten in people with Hypertrophic Cardiomyopathy and Obstructive Hypertrophic Cardiomyopathy, run by Bristol-Myers Squibb at 68 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Approximately 30 sites that enrolled participants in the MAVERICK-HCM (MYK-461-006) study in the United States (US) will initiate this study. Approximately 90 sites that enrolled participants in the EXPLORER-HCM (MYK-461-005) study in the US, Europe, and Israel will initiate this study. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
mavacamten
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
314 participants
Where
68 sitesin 13 countries
Study dates
27 Sep 2018to 16 Jan 2026
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has completed the Parent Study through to the EOS Visit within 90 days of consent. (Participants who are beyond the 90-day window from EOS Visit may be included in this study pending MyoKardia Medical Monitoring approval) Participants who prematurely discontinued from the Parent Study or the MAVA-LTE study may be considered for inclusion.
  • Has a body weight greater than 45 kg at the Screening Visit
  • Has adequate acoustic windows to enable accurate TTEs.
  • Has documented LVEF ≥ 50% by echocardiography core laboratory read of screening TTE at rest.
  • Has safety laboratory parameters (chemistry, hematology, coagulation, and urinalysis) within normal limits (according to the central laboratory reference range).
  • Female participants must not be pregnant or lactating and, if sexually active, must use one of the following highly effective birth control methods from the Screening Visit through 90 days after the last dose of investigational medicinal product (IMP).
  • In addition to the above contraceptive requirements for female participants, male partners must also use a contraceptive (eg. barrier, condom, or vasectomy).

Who cannot join

  • Has any ECG abnormality considered by the investigator to pose a risk to participant safety (eg. second degree atrioventricular block type II).
  • Has a history of syncope or a history of sustained ventricular tachyarrhythmia with exercise between Parent Study EOS Visit and Screening Visit.
  • Has a history of resuscitated sudden cardiac arrest or known history of appropriate implantable cardioverter-defibrillator (ICD) discharge for life-threatening ventricular arrhythmia between Parent Study EOS Visit and Screening Visit. (Note: history of anti-tachycardia pacing (ATP) is allowed).• Currently treated with disopyramide or ranolazine (within 14 days prior to Screening) or treatment with disopyramide or ranolazine is planned during the study.
  • Has any acute or serious comorbid condition (eg. major infection or hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction) that, in the judgment of the Investigator, could lead to premature termination of study participation or interfere with the measurement or interpretation of the efficacy and safety assessments in the study.
  • History of clinically significant malignant disease that developed since enrollment in the Parent Study.
  • Is unable to comply with the study requirements, including the number of required visits to the clinical site.
  • Has participated in a clinical trial in which the participant received any investigational drug (or is currently using an investigational device) within 30 days prior to Screening, or at least 5 times the respective elimination half-life (whichever is longer), except for participation in MAVERICK-HCM or EXPLORER-HCM. Prior participation in a non-interventional observational study is allowed.

Trial locations and contacts

68 sites in 13 countries.

68 sites in 13 countries

United States31 sites

  • Local Institution - 0051

    Ann Arbor, Michigan, 48109

  • Local Institution - 0068

    Bethlehem, Pennsylvania, 18015

  • Local Institution - 0054

    Boston, Massachusetts, 02115

  • Local Institution - 0071

    Charlotte, North Carolina, 28204

  • Local Institution - 0053

    Charlottesville, Virginia, 22903

  • Local Institution - 0050

    Chicago, Illinois, 60611

  • Local Institution - 0052

    Cincinnati, Ohio, 45267

  • Local Institution - 0061

    Dallas, Texas, 75390

  • Local Institution - 0047

    Durham, North Carolina, 27710

  • Local Institution - 0074

    Grand Rapids, Michigan, 49503

  • Local Institution - 0055

    Houston, Texas, 77030

  • Local Institution - 0057

    Houston, Texas, 77030

  • Local Institution - 0070

    Indianapolis, Indiana, 46260

  • Local Institution - 0049

    Iowa City, Iowa, 52242

  • Local Institution - 0067

    Jacksonville, Florida, 32224

  • Local Institution - 0058

    Los Angeles, California, 90027

  • Local Institution - 0073

    Memphis, Tennessee, 38104

  • Local Institution - 0072

    Murray, Utah, 84107-5701

  • Local Institution - 0043

    New Haven, Connecticut, 06520-8017

  • Local Institution - 0060

    New York, New York, 10016

  • Local Institution - 0056

    New York, New York, 10032

  • Local Institution - 0046

    Philadelphia, Pennsylvania, 19104

  • Local Institution - 0064

    Pittsburgh, Pennsylvania, 15213

  • Local Institution - 0044

    Portland, Oregon, 97239

  • Local Institution - 0059

    Richmond, Virginia, 23298

  • Local Institution - 0062

    Salt Lake City, Utah, 84112

  • Local Institution - 0066

    San Francisco, California, 94143

  • Local Institution - 0045

    Scottsdale, Arizona, 85259

  • Local Institution - 0065

    Seattle, Washington, 98195

  • Local Institution - 0048

    St Louis, Missouri, 63110

  • Local Institution - 0063

    Stanford, California, 94305

Other trials in United States

Israel6 sites

  • Local Institution - 0027

    Jerusalem, 9112001

  • Local Institution - 0024

    Petah Tikva, 4941492

  • Local Institution - 0022

    Ramat Gan, 52621

  • Local Institution - 0025

    Rehovot, 76100

  • Local Institution - 0023

    Safed, 13100

  • Local Institution - 0026

    Tel Aviv, 6423906

Other trials in Israel

Spain5 sites

  • Local Institution - 0038

    A Coruña, 15006

  • Local Institution - 0037

    El Palmar, 30120

  • Local Institution - 0040

    Madrid, 28034

  • Local Institution - 0039

    Majadahonda, 28222

  • Local Institution - 0041

    Seville, 41009

Other trials in Spain

France4 sites

  • Local Institution - 0014

    Nantes, 44093

  • Local Institution - 0017

    Paris, 75013

  • Local Institution - 0016

    Paris, 75015

  • Local Institution - 0015

    Toulouse, 31059

Other trials in France

Germany4 sites

  • Local Institution - 0020

    Bad Nauheim, 61231

  • Local Institution - 0018

    Dresden, 01277

  • Local Institution - 0019

    Göttingen, 37075

  • Local Institution - 0021

    Heidelberg, 69120

Other trials in Germany

Poland4 sites

  • Local Institution - 0033

    Katowice, 40-555

  • Local Institution - 0034

    Krakow, 31-501

  • Local Institution - 0031

    Poznan, 61-848

  • Local Institution - 0032

    Warsaw, 04-628

Other trials in Poland

Belgium3 sites

  • Local Institution - 0002

    Aalst, 9300

  • Local Institution - 0001

    Brussels, 1070

  • Local Institution - 0003

    Edegem, 2650

Other trials in Belgium

Denmark3 sites

  • Local Institution - 0011

    Aarhus, 8000

  • Local Institution - 0012

    Frederiksberg, 2000

  • Local Institution - 0013

    Odense, 5000

Other trials in Denmark

Czechia2 sites

  • Local Institution - 0010

    Prague, 128 08

  • Local Institution - 0009

    Prague, 140 21

Other trials in Czechia

Netherlands2 sites

  • Local Institution - 0029

    Maastricht, 6229 HX

  • Local Institution - 0030

    Rotterdam, 3015 CE

Other trials in Netherlands

Portugal2 sites

  • Local Institution - 0036

    Almada, 2805-267

  • Local Institution - 0035

    Lisbon, 1500-650

Other trials in Portugal

Italy1 site

  • Local Institution - 0028

    Florence, 50139

Other trials in Italy

United Kingdom1 site

  • Local Institution - 0042

    London, W1G 8PH

Other trials in United Kingdom

About this study

Official title: A Long-Term Safety Extension Study of Mavacamten (MYK-461) in Adults With Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)

Approximately 30 sites that enrolled participants in the MAVERICK-HCM (MYK-461-006) study in the United States (US) will initiate this study.

Approximately 90 sites that enrolled participants in the EXPLORER-HCM (MYK-461-005) study in the US, Europe, and Israel will initiate this study.

Note: Approximately 30 centers overlap between MAVERICK and EXPLORER.

Being tested
mavacamten
Keywords
Symptomatic, left ventricular outflow tract gradient
Medical subject headings
Cardiomyopathy, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mavacamtenDrug

    Also called MYK-461

    mavacamten capsules

Study groups in NCT03723655
Study groupRoleWhat they receive
Group 1ExperimentalActive Treatment for participants with base target trough concentration
Receives: Drug: mavacamten
Group 2ExperimentalActive Treatment for participants with higher target trough concentration
Receives: Drug: mavacamten
Group 3ExperimentalActive Treatment for participants dose titrated to clinical response
Receives: Drug: mavacamten

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency and severity of treatment-emergent adverse events and serious adverse events

    Measured: 252 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2018
  2. Study start27 Sep 2018
  3. Primary completion16 Jan 2026
  4. Study completion16 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
314 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03723655
Sponsor's protocol ID
CV027-003
Status last verified
Feb 2026
First submitted
24 Oct 2018
Last updated
20 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Publications

  • Olivotto I, Garcia-Pavia P, Tian Z, Owens AT, Lakdawala NK MD, Balaratnam G, Zhong Y, Memaj A, Barrett YC, Desai M. Mavacamten monotherapy in obstructive hypertrophic cardiomyopathy: An integrated analysis of phase 3 clinical trials. Am Heart J. 2026 Aug 24;303:107587. doi: 10.1016/j.ahj.2026.107587. Online ahead of print.

    PubMed 42636950

  • Garcia-Pavia P, Oreziak A, Masri A, Barriales-Villa R, Abraham TP, Owens AT, Jensen MK, Wojakowski W, Seidler T, Hagege A, Lakdawala NK, Wang A, Wheeler MT, Choudhury L, Balaratnam G, Shah A, Fox S, Hegde SM, Olivotto I. Long-term effect of mavacamten in obstructive hypertrophic cardiomyopathy. Eur Heart J. 2024 Dec 16;45(47):5071-5083. doi: 10.1093/eurheartj/ehae579.

    PubMed 39217450

  • Rader F, Oreziak A, Choudhury L, Saberi S, Fermin D, Wheeler MT, Abraham TP, Garcia-Pavia P, Zwas DR, Masri A, Owens A, Hegde SM, Seidler T, Fox S, Balaratnam G, Sehnert AJ, Olivotto I. Mavacamten Treatment for Symptomatic Obstructive Hypertrophic Cardiomyopathy: Interim Results From the MAVA-LTE Study, EXPLORER-LTE Cohort. JACC Heart Fail. 2024 Jan;12(1):164-177. doi: 10.1016/j.jchf.2023.09.028.

    PubMed 38176782

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing mavacamten in people with Hypertrophic Cardiomyopathy and Obstructive Hypertrophic Cardiomyopathy, run by Bristol-Myers Squibb at 68 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, Israel, Spain, France, Germany and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency and severity of treatment-emergent adverse events and serious adverse events (time frame: 252 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03723655, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.

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