mavacamten for Heart Failure With Preserved Ejection Fraction (HFpEF)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Heart Failure With Preserved Ejection Fraction (HFpEF)+1 More
mavacamten - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to see if it's safe and effective for people with heart failure who have a preserved ejection fraction.

Eligible Conditions
  • Heart Failure With Preserved Ejection Fraction (HFpEF)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 0 Secondary · Reporting Duration: 26 weeks

26 weeks
Frequency and severity of treatment-emergent adverse events, adverse events of special interest, and serious adverse events.
Mavacamten effect on NT-proBNP levels (at rest)
Mavacamten effect on cTnI levels (at rest)
Mavacamten effect on cTnT levels (at rest)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Mavacamten (MYK-461)
1 of 2
mavacamten (MYK-461)
1 of 2

Experimental Treatment

35 Total Participants · 2 Treatment Groups

Primary Treatment: mavacamten · No Placebo Group · Phase 2

Mavacamten (MYK-461)
Drug
Experimental Group · 1 Intervention: Mavacamten · Intervention Types: Drug
mavacamten (MYK-461)
Drug
Experimental Group · 1 Intervention: mavacamten · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mavacamten
2018
Completed Phase 3
~310
Mavacamten
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 26 weeks

Who is running the clinical trial?

MyoKardia, Inc.Lead Sponsor
12 Previous Clinical Trials
999 Total Patients Enrolled
Bristol-Myers SquibbLead Sponsor
2,481 Previous Clinical Trials
3,919,554 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are at least 50 years old.
You have had a previous hospitalization for heart failure with documented radiographic evidence of pulmonary congestion.
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).
You have documented LVEF ≥60% at the Screening visit and no history of prior LVEF ≤ 45%.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 4th, 2021

Last Reviewed: November 29th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.