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Aficamten for Hypertrophic Cardiomyopathy (ACACIA-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
NYHA class II or III
Respiratory exchange ratio of ≥ 1.00 at screening by cardiopulmonary exercise testing (CPET) and predicted peak oxygen uptake (pVO2) ≤ 90% for age and sex
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of study, week 72
Awards & highlights

ACACIA-HCM Trial Summary

This trial will study if a drug can improve quality of life, exercise capacity & outcomes of patients with an enlarged heart.

Who is the study for?
Adults aged 18-85 with non-obstructive hypertrophic cardiomyopathy (nHCM), specifically those who are somewhat limited in physical activity but not bedridden. They must have a body mass index under 40, no recent heart surgeries or treatments with similar drugs, and be able to exercise on a treadmill or bicycle.Check my eligibility
What is being tested?
The trial is testing Aficamten against a placebo to see if it improves life quality, exercise ability, and health outcomes for people with nHCM. Participants will either receive the actual drug or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
While specific side effects of Aficamten aren't listed here, common ones for heart medications may include dizziness, changes in blood pressure or heart rhythm, fatigue, headache, and potential gastrointestinal issues.

ACACIA-HCM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My heart condition mildly or moderately affects my daily activities.
Select...
My exercise test shows I use a lot of oxygen and my peak oxygen level is low for my age and sex.
Select...
I have been diagnosed with non-obstructive hypertrophic cardiomyopathy.

ACACIA-HCM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of study, week 72
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of study, week 72 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS)
Secondary outcome measures
Change in LAVI
Change in NT-proBNP
Change in composite of two Z-scores of CPET parameters (pVO2 and VE/VCO2 slope)
+2 more

ACACIA-HCM Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AficamtenExperimental Treatment1 Intervention
Participants in this arm will receive a single daily oral dose of 5 mg, 10 mg, 15 mg, or 20 mg of aficamten with dose levels guided by echocardiography assessments, for up to 72 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants in this arm will receive placebo, for up to 72 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aficamten
2023
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

CytokineticsLead Sponsor
40 Previous Clinical Trials
14,888 Total Patients Enrolled
Cytokinetics MDStudy DirectorCytokinetics
2 Previous Clinical Trials
354 Total Patients Enrolled

Frequently Asked Questions

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

Could I be included in this research endeavor?

"This clinical trial is looking for 420 individuals suffering from hypertrophic cardiomyopathy and aged 18 to 85. To be accepted, patients must meet these requirements."

Answered by AI

Is the eligibility criterion of this clinical trial restricted to individuals below sixty?

"This trial is accepting patients with ages ranging from 18 to 85. Additionally, there are 29 clinical trials for minors and 200 studies targeting elderly individuals."

Answered by AI

How many participants will this experiment encompass?

"Affirmative, the trial is actively recruiting patients. Initially posted on August 30th 2023 and updated as recently as October 12th of that same year, this clinical study requires 420 participants from two separate medical sites."

Answered by AI

Are there any open slots available in this research initiative?

"Evidently, this medical study is looking for participants, per the details available on clinicaltrials.gov. The trial commenced recruiting on August 30th 2023 and was most recently altered on October 12th 2023."

Answered by AI

What risks are associated with Aficamten therapy?

"Aficamten has been sufficiently well-studied, garnering a safety rating of 3. This is due to the existence of data supporting both its efficacy and safety in multiple trials."

Answered by AI

Who else is applying?

What site did they apply to?
The Lindner Research Center at The Christ Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I have HCM and looking to improve quality of life. Very active and want to stay active.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic nHCM
2023. "Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic nHCM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06081894.
All > Hypertrophic Cardiomyopathy > Vancouver
~280 spots leftby Jun 2026
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