← Back to Search

Cardiac Myosin Inhibitor

Mavacamten for Hypertrophic Cardiomyopathy (VALOR-HCM Trial)

Phase 3

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with oHCM consistent with current ACCF/AHA 2011 and meet their recommendations for invasive therapies

At least 18 years old at screening and body weight > 45 kg at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 16

Awards & highlights

VALOR-HCM Trial Summary

This trial will test if mavacamten can reduce the number of heart procedures in people with symptomatic obstructive hypertrophic cardiomyopathy who are eligible for the procedure based on current guidelines.

Who is the study for?

Adults over 18 with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) who weigh more than 45 kg, have a left ventricular ejection fraction (LVEF) of at least 60%, and oxygen saturation above 90%. They should be eligible for septal reduction therapy and not have had prior invasive septal reductions or recent medication changes.Check my eligibility

What is being tested?

The study is testing Mavacamten against a placebo to see if it can reduce the need for septal reduction procedures in patients with oHCM. Participants will be randomly assigned to receive either the drug or a placebo without knowing which one they are getting.See study design

What are the potential side effects?

While specific side effects of Mavacamten are not listed here, common side effects may include symptoms related to heart function changes, such as dizziness or shortness of breath. Patients will be monitored for any adverse reactions.

VALOR-HCM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with obstructive hypertrophic cardiomyopathy according to the latest guidelines.

Select...

I am over 18 years old and weigh more than 45 kg.

VALOR-HCM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite of Decision to Proceed With Septal Reduction Therapy (SRT) and SRT Guideline Eligible at Week 16

Secondary outcome measures

Change From Baseline to Week 16 in Cardiac Troponin

Change From Baseline to Week 16 in Kansas City Cardiomyopathy Questionnaire 23-item Version, Clinical Summary Score (KCCQ-23, CSS)

Change From Baseline to Week 16 in N-Terminal Pro-b-Type Natriuretic Peptide (NT-proBNP)

+2 more

VALOR-HCM Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Drug: MavacamtenExperimental Treatment1 Intervention

Mavacamten Capsules Other names: MYK-461

Group II: Drug: PlaceboPlacebo Group1 Intervention

Matching Placebo Capsules

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mavacamten

2022

Completed Phase 1

~340

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,638 Previous Clinical Trials

4,128,402 Total Patients Enrolled

MyoKardia, Inc.Lead Sponsor

12 Previous Clinical Trials

941 Total Patients Enrolled

Media Library

Mavacamten (Cardiac Myosin Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04349072 — Phase 3

Hypertrophic Cardiomyopathy Research Study Groups: Drug: Placebo, Drug: Mavacamten

Hypertrophic Cardiomyopathy Clinical Trial 2023: Mavacamten Highlights & Side Effects. Trial Name: NCT04349072 — Phase 3

Mavacamten (Cardiac Myosin Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04349072 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there several hospitals running this trial in the city?

"Selecting the location nearest you is key to reducing travel time if you enroll in this trial, which is currently taking place at 47 sites. The locations are primarily centred around Grand Rapids, Ann Arbor and Rochester but also include other cities."

Answered by AI

Are there any available openings for new participants in this clinical trial?

"No, this study is not currently looking for new patients. Although the trial's last update was on July 17th, 2020, it is no longer recruiting candidates. There are however 241 other trials that might be of interest and are actively enrolling patients."

Answered by AI

What is the Mavacamten approval status from the FDA?

"There is prior clinical data supporting Mavacamten's safety, so it received a score of 3."

Answered by AI

Do we have a precedent for using Mavacamten to treat this condition?

"Currently, 5 different research studies are underway that focus on Mavacamten. Of these live studies, 3 have progressed to Phase 3 clinical trials. However, the majority of research locations for Mavacamten are based in Durham, North carolina with a total of 198 study sites."

Answered by AI

Has this research been conducted before?

"Global research teams are actively investigating Mavacamten's effects and potential applications. 61 cities across 16 countries are running active studies, with the first one having been performed in 2018. MyoKardia, Inc. sponsored the initial study which only involved 13 patients. It completed Phase 2 drug approval stage and now 18291 studies have been completed since 2018."

Answered by AI

What is the total number of participants in this clinical trial?

"recruitment for this particular clinical trial has ceased. The listing was first posted on July 6th, 2020 and edited as recently as July 17th, 2022. However, there are 236 other trials related to cardiomyopathies that are still recruiting patients along with 5 different trials involving Mavacamten."

Answered by AI

Recent research and studies

Current Cardiology ReportsJournal

Mavacamten, a Novel Therapeutic Strategy for Obstructive Hypertrophic Cardiomyopathy

Zampieri, Mattia, Alessia Argirò, Alberto Marchi, Martina Berteotti, Mattia Targetti, Alessandra Fornaro, Alessia Tomberli, Pierluigi Stefàno, Niccolò Marchionni, and Iacopo Olivotto. 2021. “Mavacamten, a Novel Therapeutic Strategy for Obstructive Hypertrophic Cardiomyopathy”. Current Cardiology Reports. Springer Science and Business Media LLC. doi:10.1007/s11886-021-01508-0.

American Heart JournalJournal

Study Design and Rationale of VALOR-HCM: Evaluation of Mavacamten in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy Who Are Eligible for Septal Reduction Therapy

Desai, Milind Y., Kathy Wolski, Anjali Owens, Srihari S. Naidu, Jeffrey B. Geske, Nicholas G. Smedira, Hartzell Schaff, et al.. 2021. “Study Design and Rationale of VALOR-HCM: Evaluation of Mavacamten in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy Who Are Eligible for Septal Reduction Therapy”. American Heart Journal. Elsevier BV. doi:10.1016/j.ahj.2021.05.007.

Journal of the American College of CardiologyJournal

Myosin Inhibition in Patients with Obstructive Hypertrophic Cardiomyopathy Referred for Septal Reduction Therapy

Desai, Milind Y., Anjali Owens, Jeffrey B. Geske, Kathy Wolski, Srihari S. Naidu, Nicholas G. Smedira, Paul C. Cremer, et al.. 2022. “Myosin Inhibition in Patients with Obstructive Hypertrophic Cardiomyopathy Referred for Septal Reduction Therapy”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2022.04.048.

clinicaltrials.govStudy