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Mavacamten for Heart Failure (EMBARK-HFpEF Trial)
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.
EMBARK-HFpEF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowEMBARK-HFpEF Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 3 trial • 251 Patients • NCT03470545EMBARK-HFpEF Trial Design
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Who is running the clinical trial?
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- I have severe lung disease needing specific treatments.I have documented evidence of heart failure.I am currently on medication or will be during the study.You have a very high body weight for your height.I have had a serious heart failure episode needing treatment in the last 30 days.I have a serious heart valve problem.You have fainted or experienced abnormal heart rhythms with exercise in the last 6 months.My weight is over 45 kg.I am 50 years old or older.Your heart function, as measured by a specific test, falls within a certain range.I have been revived from sudden cardiac arrest or my heart device has activated in the last 6 months.My heart function and structure meet specific health criteria.I have ongoing atrial fibrillation and haven't been on blood thinners for at least 4 weeks.Your NT-proBNP level at screening is higher than 2000 pg/mL.I have been diagnosed with a heart condition that causes thickening or buildup affecting heart function.
- Group 1: mavacamten (MYK-461)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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."
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."
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