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Myosin Inhibitor
Aficamten vs Metoprolol for Hypertrophic Cardiomyopathy (MAPLE-HCM Trial)
Phase 3
Recruiting
Research Sponsored by Cytokinetics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with oHCM per the specified criteria by cardiac magnetic resonance imaging (CMR) or echocardiography
Males and females between 18 to 85 years of age, inclusive, at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 24
Awards & highlights
MAPLE-HCM Trial Summary
This trial tests a new drug to see if it can safely reduce heart problems in people with hypertrophic cardiomyopathy.
Who is the study for?
Adults aged 18-85 with symptomatic hypertrophic cardiomyopathy and obstruction in the heart's left ventricle can join. They should have a BMI under 35, be class II or III for heart symptoms, and meet specific heart imaging criteria. Exclusions include high blood pressure at rest, certain other heart conditions, intolerance to beta blockers, recent severe arrhythmias or fainting episodes.Check my eligibility
What is being tested?
The trial is testing Aficamten against Metoprolol Succinate to see which is better for adults with obstructive hypertrophic cardiomyopathy. Participants will receive varying doses of either drug or matching placebos to compare effectiveness and safety.See study design
What are the potential side effects?
Potential side effects may include changes in blood pressure or heart rate, dizziness due to low blood pressure, fatigue, disturbances in heartbeat rhythm (arrhythmias), and possibly other cardiovascular-related issues.
MAPLE-HCM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart condition was confirmed by a heart scan or ultrasound.
Select...
I am between 18 and 85 years old.
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My heart condition mildly or moderately affects my daily activities.
MAPLE-HCM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in peak oxygen uptake (pVO2) by cardiopulmonary exercise testing (CPET)
Secondary outcome measures
Change from baseline values in NT-proBNP from baseline to Week 24
Change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS)
Change in left atrial volume index (LAVI)
+3 moreMAPLE-HCM Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Aficamten up to 20 mg plus placebo for metoprololExperimental Treatment2 Interventions
Patients will receive doses of 5 mg, 10 mg, 15 mg or 20 mg of aficamten (CK-3773274) plus placebo for metoprolol succinate with dose levels guided by echocardiography assessments for up to 24 weeks.
Group II: Metoprolol succinate up to 200 mg plus placebo for aficamtenActive Control2 Interventions
Patients will receive 50 mg, 100 mg, 150 mg or 200 mg of metoprolol succinate plus placebo for aficamten (CK-3773274) with dose levels guided by echocardiography and heart rate assessments for up to 24 weeks.
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Who is running the clinical trial?
CytokineticsLead Sponsor
40 Previous Clinical Trials
15,138 Total Patients Enrolled
Scientific LeadershipStudy DirectorCytokinetics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to have a specific type of heart test that shows certain results.My heart condition was confirmed by a heart scan or ultrasound.I am scheduled for a heart procedure that can't be postponed.I have a history of irregular heartbeats.I have taken disopyramide in the last 4 weeks.I have a condition that causes thickening of the heart muscle, similar to oHCM.I have had a procedure to reduce heart muscle thickness within the last 6 months.My heart condition mildly or moderately affects my daily activities.I have a serious heart valve condition.Your oxygen level is less than 90% when breathing normally.You weigh less than 35 kilograms per square meter.I cannot tolerate or am medically advised against beta blocker medications.I have had fainting spells or dangerous heart rhythms during exercise in the last 6 months.I need to take beta blockers or calcium-channel blockers for a condition other than obstructive hypertrophic cardiomyopathy.I am between 18 and 85 years old.Your hemoglobin level is at least 10 grams per deciliter.Your heart beats more than 100 times in a minute when you are resting.Your blood pressure when you are resting is higher than 160 mmHg.I stopped taking mavacamten at least 8 weeks ago.I have had heart muscle weakness or stress-related heart issues.You cannot use a treadmill or a bicycle for exercise.I have been treated with aficamten or could not tolerate mavacamten.
Research Study Groups:
This trial has the following groups:- Group 1: Aficamten up to 20 mg plus placebo for metoprolol
- Group 2: Metoprolol succinate up to 200 mg plus placebo for aficamten
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Is participation in this trial confined to individuals aged thirty and below?
"This medical study is in search of patients aged between 18 and 85 years old."
Answered by AI
Are there eligibility criteria that must be met to participate in this clinical research?
"This trial is searching for 170 individuals between 18 and 85 who suffer from hypertrophic cardiomyopathy. The following prerequisites must also be satisfied: Gender of either sex, BMI less than 35kg/m2, LV hypertrophy with a non-dilated chamber in the absence of other cardiac issues, ≥ 15mm or ≥ 13 mm on one wall segment plus a gene mutation that causes HCM or positive family history, NYHA class II-III symptoms at rest with an LVOT-G over 30 mmHg post Valsalva or 50mmHg afterwards , haemoglobin amounts above 10 g/dl"
Answered by AI
Is it still possible to sign up for this research endeavor?
"The current status of this trial, according to data hosted on clinicaltrials.gov, is that it no longer actively recruiting patients since its last update on June 30th 2023. However, there are over 200 other studies accepting participants right now."
Answered by AI
What is the Food and Drug Administration's standing on Aficamten (CK-3773274) dosages of 5 mg, 10 mg, 15 mg and 20 mg?
"Our experts at Power have determined Aficamten (CK-3773274) has a safety rating of 3, as the phase 3 trial provides ample evidence in favor of efficacy and security."
Answered by AI
In which regions of the US is this study being administered?
"This research is being conducted in 10 distinct sites, with the primary ones located at Cedars-Sinai Medical Center (Smidt Heart Institute) in Los Angeles, California; Massachusetts General Hospital in Boston, Massachusetts; and Brigham and Women's Hospital in Burlington, Oregon."
Answered by AI
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