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Long-term Safety of Aficamten for Hypertrophic Cardiomyopathy (FOREST-HCM Trial)

Q: What prerequisites must potential participants meet to qualify for this clinical trial?

For admittance into this research initiative, patients must demonstrate hypertrophic symptoms and fall within the ages of 18 to 85 years old. Approximately 300 participants are needed for successful completion.

Q: Can individuals take CK-3773274 (5 - 15 mg) without any adverse effects?

With only preliminary clinical data available to support its safety, CK-3773274 (5 - 15 mg) was assigned a score of 2 on the Power scale.

Q: Is the research team now enlisting participants for this experiment?

According to clinicaltrials.gov, this particular medical experiment is no longer searching for participants. The trial was initially launched on the 6th of May 2021 and last updated on November 3rd 2022; however, there are still 219 other studies actively recruiting patients at present.

Q: How many medical centers are facilitating this research endeavor?

This research initiative is recruiting at 15 different healthcare institutions, including Saint Luke's Hospital of <a href="https://www.withpower.com/clinical-trials/kansas">Kansas</a> City in Kansas City, Holy Cross Hospital / <a href="https://www.withpower.com/clinical-trials/cardiology">Cardiology</a> Associates in Fort Lauderdale, and University of <a href="https://www.withpower.com/clinical-trials/virginia">Virginia</a> Health System University Hospital in Charlottesville. Additionally, there are 12 more recruitment sites available to prospective participants.

Q: Is this trial only available to adults or are minors also eligible for enrollment?

This trial has a restricted age range of 18 to 85 years old. Younger patients are represented by 25 studies, while those over 65 have been enrolled in 194 research projects.

Q: What is the aim of this experiment?

This clinical trial's primary objective is to measure the presence of adverse reactions in patients with HCM as a result of taking CK-3773274 over an extended period up to 5 years. The secondary aims are to ascertain how the drug impacts peak LVOT-G at rest, document Serious Adverse Events (SAEs) associated with its use, and record any cases where LVEF falls below 50%.

Phase 2

Waitlist Available

Research Sponsored by Cytokinetics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to end of study, up to 5 years

Awards & highlights

FOREST-HCM Trial Summary

This trial will help assess the long-term safety of the drug aficamten.

Who is the study for?

This trial is for individuals who have completed a previous Cytokinetics study with CK-3773274 and have a left ventricular ejection fraction (LVEF) of 55% or higher. It's not open to those who've had certain heart treatments, recent atrial fibrillation, or an investigational drug/device within the last month.Check my eligibility

What is being tested?

The trial is focused on gathering long-term safety data for Aficamten (CK-3773274), which will be administered in doses ranging from 5 to 20 mg. This is an open-label study where all participants receive the drug.See study design

What are the potential side effects?

While specific side effects are not listed here, this study aims to monitor any adverse reactions over a prolonged period as patients take Aficamten at varying dosages.

FOREST-HCM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to end of study, up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to end of study, up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of study, up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events observed during dosing of CK-3773274 in patients with HCM

Secondary outcome measures

Incidence of left ventricular ejection fraction (LVEF) < 50% observed during dosing of CK-3773274 in patients with HCM

Incidence of serious adverse events observed during dosing of CK-3773274 in patients with HCM

Long-term effects of CK-3773274 on left ventricular outflow tract gradient (LVOT G) in patients with oHCM

FOREST-HCM Trial Design

1Treatment groups

Experimental Treatment

Group I: CK-3773274 up to 20 mgExperimental Treatment1 Intervention

Patients in this arm take daily dose of CK-3773274. Each patient will start at the lowest prespecified dose and titrate up to their maximum tolerated dose.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

CytokineticsLead Sponsor

40 Previous Clinical Trials

14,708 Total Patients Enrolled

Cytokinetics, MDStudy DirectorCytokinetics

5 Previous Clinical Trials

980 Total Patients Enrolled

Media Library

CK-3773274 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04848506 — Phase 2

Hypertrophic Cardiomyopathy Research Study Groups: CK-3773274 up to 20 mg

Hypertrophic Cardiomyopathy Clinical Trial 2023: CK-3773274 Highlights & Side Effects. Trial Name: NCT04848506 — Phase 2

CK-3773274 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04848506 — Phase 2

Frequently Asked Questions

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

What prerequisites must potential participants meet to qualify for this clinical trial?

"For admittance into this research initiative, patients must demonstrate hypertrophic symptoms and fall within the ages of 18 to 85 years old. Approximately 300 participants are needed for successful completion."

Answered by AI

Can individuals take CK-3773274 (5 - 15 mg) without any adverse effects?

"With only preliminary clinical data available to support its safety, CK-3773274 (5 - 15 mg) was assigned a score of 2 on the Power scale."

Answered by AI

Is the research team now enlisting participants for this experiment?

"According to clinicaltrials.gov, this particular medical experiment is no longer searching for participants. The trial was initially launched on the 6th of May 2021 and last updated on November 3rd 2022; however, there are still 219 other studies actively recruiting patients at present."

Answered by AI

How many medical centers are facilitating this research endeavor?

"This research initiative is recruiting at 15 different healthcare institutions, including Saint Luke's Hospital of Kansas City in Kansas City, Holy Cross Hospital / Cardiology Associates in Fort Lauderdale, and University of Virginia Health System University Hospital in Charlottesville. Additionally, there are 12 more recruitment sites available to prospective participants."

Answered by AI

Is this trial only available to adults or are minors also eligible for enrollment?

"This trial has a restricted age range of 18 to 85 years old. Younger patients are represented by 25 studies, while those over 65 have been enrolled in 194 research projects."

Answered by AI

What is the aim of this experiment?

"This clinical trial's primary objective is to measure the presence of adverse reactions in patients with HCM as a result of taking CK-3773274 over an extended period up to 5 years. The secondary aims are to ascertain how the drug impacts peak LVOT-G at rest, document Serious Adverse Events (SAEs) associated with its use, and record any cases where LVEF falls below 50%."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM

2021. "Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04848506.

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