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Cardiac Myosin Inhibitor
Mavacamten for Hypertrophic Cardiomyopathy
Phase 2 & 3
Waitlist Available
Research Sponsored by MyoKardia, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has a body weight greater than 45 kg at the Screening Visit
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 252 weeks
Awards & highlights
Study Summary
This trial will enroll 2,400 participants with hypertrophic cardiomyopathy (HCM) to receive MYK-461 or placebo.
Who is the study for?
This trial is for adults over 45 kg who completed the MAVERICK-HCM or EXPLORER-HCM studies, have a left ventricular ejection fraction (LVEF) of ≥50%, and can undergo accurate heart scans. Women must not be pregnant, breastfeeding, and use effective birth control if sexually active. Exclusions include certain ECG abnormalities, recent serious cardiac events or arrhythmias, current treatment with specific drugs like disopyramide or ranolazine, significant other diseases that could affect study results or compliance.Check my eligibility
What is being tested?
The study tests the long-term safety of Mavacamten in patients with Hypertrophic Cardiomyopathy who previously participated in related trials. It will take place across approximately 90 sites globally including some locations from previous studies to ensure continuity and reliability of data.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with medications treating cardiomyopathy may include dizziness, low blood pressure, heart rhythm problems, fatigue, shortness of breath among others. The exact side effects will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh more than 45 kg.
Select...
I am not pregnant or breastfeeding and will use effective birth control during and 90 days after the trial.
Select...
My heart's pumping ability is normal or above normal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 252 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~252 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency and severity of treatment-emergent adverse events and serious adverse events
Side effects data
From 2020 Phase 3 trial • 251 Patients • NCT0347054521%
Dizziness
15%
Dyspnoea
12%
Nasopharyngitis
12%
Headache
8%
Back pain
8%
Upper respiratory tract infection
8%
Atrial Fibrillation
8%
Cough
6%
Gastroesophageal reflux disease
6%
Arthralgia
6%
Palpitations
6%
Syncope
6%
Fatigue
4%
Diarrhoea
2%
Stress cardiomyopathy
2%
Angina pectoris
1%
Cardiac Failure
1%
Bacterial colitis
1%
Systolic dysfunction
1%
Diverticulitis
1%
Cardiogenic shock
1%
Device inappropriate shock delivery
1%
SLE
1%
Ischaemic stroke
1%
Pericardial effusion
1%
Atrial septal defect
1%
Infection
1%
Contusion
1%
Forearm Fracture
1%
Abdominal Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mavacamten (MYK-461)
Placebo
Trial Design
3Treatment groups
Experimental Treatment
Group I: Group 3Experimental Treatment1 Intervention
Active Treatment for participants dose titrated to clinical response
Group II: Group 2Experimental Treatment1 Intervention
Active Treatment for participants with higher target trough concentration
Group III: Group 1Experimental Treatment1 Intervention
Active Treatment for participants with base target trough concentration
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mavacamten
2018
Completed Phase 3
~330
Find a Location
Who is running the clinical trial?
MyoKardia, Inc.Lead Sponsor
12 Previous Clinical Trials
771 Total Patients Enrolled
Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,128,232 Total Patients Enrolled
Medical Information TeamStudy DirectorMyoKardia, Inc.
1 Previous Clinical Trials
251 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I weigh more than 45 kg.I have developed a significant cancer since joining the initial study.Your blood and urine test results are within the normal range according to the lab's standards.You have a history of fainting or a specific type of heart rhythm issue during exercise.I am currently taking or plan to take disopyramide or ranolazine.I haven't taken any experimental drugs or used investigational devices recently, except in the MAVERICK-HCM or EXPLORER-HCM studies.I am not pregnant or breastfeeding and will use effective birth control during and 90 days after the trial.My heart can be clearly seen on ultrasound.My heart's pumping ability is normal or above normal.You have a history of a specific type of serious heart problem that required a device to shock your heart back to a normal rhythm.You have a heart condition that could be risky for your safety, like a specific abnormal heart rhythm.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1
- Group 2: Group 2
- Group 3: Group 3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What other mavacamten studies have been done in the past?
"There are currently 5 ongoing clinical trials for mavacamten, 3 of which are Phase 3 studies. Most of the locations for these trials are situated in Durham, North carolina, but there are a total of 198 sites running these mavacamten trials."
Answered by AI
Are there any slots left for new participants in this trial?
"At present, this clinical trial is not looking for new recruits. The study was originally posted on October 5th, 2018 and was last edited on September 20th, 2022. For anyone else looking for similar studies, there are 234 clinical trials actively searching for participants with obstructive hypertrophic cardiomyopathy and 5 studies for mavacamten admitting patients."
Answered by AI
What other similar research studies exist?
"Mavacamten was first trialed in 2018 with the very first study being sponsored by MyoKardia, Inc. After the initial study with 13 participants, mavacamten went on to receive Phase 2 drug approval. Now, 5 years later, there are 61 active studies in 16 countries."
Answered by AI
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