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Myosin Inhibitor

Mavacamten for Heart Failure (EMBARK-HFpEF Trial)

Phase 2
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
Documented prior objective evidence of heart failure as shown by specific criteria including previous hospitalization for heart failure, elevated LV end-diastolic pressure, elevated level of NT-proBNP or BNP, and echocardiographic evidence
Body weight is greater than 45 kg at Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks
Awards & highlights

EMBARK-HFpEF Trial 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.

Who is the study for?
This trial is for people over 50 with heart failure who have a body weight over 45 kg and documented evidence of heart failure. They must meet specific criteria related to NT-proBNP, LVEF, and NYHA class II or III symptoms. Those with certain heart conditions, severe lung disease, recent acute heart failure events, or extremely high BMI are excluded.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of mavacamten in patients with HFpEF who show elevated levels of NT-proBNP biomarkers. It's a Phase 2a trial designed to inform future studies on how mavacamten could help these patients.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include issues common to other heart medications such as dizziness, low blood pressure, changes in heartbeat rhythm or rate, fatigue, and possible worsening of the condition.

EMBARK-HFpEF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have documented evidence of heart failure.
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My weight is over 45 kg.
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I am 50 years old or older.
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My heart function and structure meet specific health criteria.

EMBARK-HFpEF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks for reporting.

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, adverse events of special interest, and serious adverse events.
Mavacamten effect on NT-proBNP levels (at rest)
Mavacamten effect on cTnT levels (at rest)

Side effects data

From 2020 Phase 3 trial • 251 Patients • NCT03470545
21%
Dizziness
15%
Dyspnoea
12%
Nasopharyngitis
12%
Headache
8%
Upper respiratory tract infection
8%
Atrial Fibrillation
8%
Cough
8%
Back pain
6%
Palpitations
6%
Arthralgia
6%
Syncope
6%
Fatigue
6%
Gastroesophageal reflux disease
4%
Diarrhoea
2%
Angina pectoris
2%
Stress cardiomyopathy
1%
Cardiogenic shock
1%
Cardiac Failure
1%
Diverticulitis
1%
SLE
1%
Ischaemic stroke
1%
Bacterial colitis
1%
Pericardial effusion
1%
Systolic dysfunction
1%
Atrial septal defect
1%
Infection
1%
Contusion
1%
Forearm Fracture
1%
Abdominal Pain
1%
Device inappropriate shock delivery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mavacamten (MYK-461)
Placebo

EMBARK-HFpEF Trial Design

1Treatment groups
Experimental Treatment
Group I: mavacamten (MYK-461)Experimental Treatment1 Intervention
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
1,017 Total Patients Enrolled
1 Trials studying Heart Failure
52 Patients Enrolled for Heart Failure
Bristol-Myers SquibbLead Sponsor
2,629 Previous Clinical Trials
4,126,281 Total Patients Enrolled
28 Trials studying Heart Failure
169,274 Patients Enrolled for Heart Failure

Media Library

Mavacamten (Myosin Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04766892 — Phase 2
Heart Failure Research Study Groups: mavacamten (MYK-461)
Heart Failure Clinical Trial 2023: Mavacamten Highlights & Side Effects. Trial Name: NCT04766892 — Phase 2
Mavacamten (Myosin Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04766892 — Phase 2

Frequently Asked Questions

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

To what extent is the trial open to participants?

"Affirmative. As indicated on clinicaltrials.gov, this experiment is actively seeking volunteers who began enrolling as of March 30th 2021 and was last updated in October 28th 2022. 35 participants are required from 42 sites across the country."

Answered by AI

Does this research endeavor represent a revolutionary approach?

"Since its debut in 2018, MyoKardia, Inc. has conducted and completed 5 trials of mavacamten across 61 cities and 16 countries. The first study included 13 participants and achieved Phase 2 drug approval status."

Answered by AI

Are there numerous places conducting the experiment within this state?

"The current list of participating sites includes the University of California San Francisco (UCSF) in San Francisco, University of Iowa Hospitals & Clinics in Iowa City, and Spectrum Health in Grand Rapids. Additionally, there are another 42 medical institutions that have been deemed eligible for this trial."

Answered by AI

Has mavacamten been studied in any other trials prior to this one?

"Mavacamten was first trialled at Duke Cardiology at Southpoint in 2018, and has since had 5 completed trials. Currently there are 5 active studies with a majority of them based out of San Francisco, California."

Answered by AI

Are recruitment efforts still ongoing for this experiment?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial, which was first published on March 30th 2021, is still accepting applicants. A total of 35 patients must be recruited from 42 different sites."

Answered by AI

What potential risks could arise from taking mavacamten?

"Our assessment of mavacamten's safety is a score of 2, since this Phase 2 trial has established some evidence towards its security but there have yet to be any studies validating the drug's effectiveness."

Answered by AI
~0 spots leftby Apr 2024