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NCT06412666RECRUITINGIRB Ready

A Study to Evaluate the Effect of Aficamten in Pediatric Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM).

(CEDAR-HCM)

Sponsored by Cytokinetics

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 40 participants interested
3% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

The purpose of this study is to evaluate the efficacy, safety and PK of aficamten in a pediatric population with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).

Who Can Participate

Inclusion Criteria

Period 1: Treatment Period
Males and females between 12 and \< 18 years of age at screening and at Day 1.
Body weight โ‰ฅ 45 kg for the initial cohort and then body weight โ‰ฅ 35 kg after at least 10 participants in the initial cohort have undergone dose titration up to Week 4 without observed events of LVEF \< 50% at the starting dose of 5 mg qd.
Core laboratory confirmation of the following oHCM echocardiographic criteria at screening:
Left ventricular (LV) hypertrophy with nondilated LV chamber in the absence of other cardiac disease.
LV end-diastolic wall thickness that meets a threshold of:
Z-score \> 2.5 in the absence of family history OR
Z-score \> 2 in the presence of positive family history or positive genetic test.
LVEF โ‰ฅ 60% AND Valsalva LVOT-G โ‰ฅ 50 mmHg.
oHCM of sarcomeric origin confirmed by genetic testing or, if unable to confirm by genetic testing, oHCM of sarcomeric origin may be presumed in the absence of history of

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

40 participants

๐ŸŽ‚

Age Range

12 Years - 17 Years

โšง

Gender

ALL

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Sponsor

Cytokinetics

Study Locations

Choose your preferred location or select flexible during enrollment

NOT_YET_RECRUITING

Phoenix

Arizona

Location available
View Phoenix location page
RECRUITING

Los Angeles

California

Location available
View Los Angeles location page
RECRUITING

Los Angeles

California

Location available
View Los Angeles location page
NOT_YET_RECRUITING

San Francisco

California

Location available
View San Francisco location page
RECRUITING

Aurora

Colorado

Location available
View Aurora location page
RECRUITING

Washington D.C.

District of Columbia

Location available
View Washington D.C. location page
NOT_YET_RECRUITING

Miami

Florida

Location available
View Miami location page
RECRUITING

Chicago

Illinois

Location available
View Chicago location page
RECRUITING

Iowa City

Iowa

Location available
View Iowa City location page

๐Ÿ“ And 17 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Hypertrophic Cardiomyopathy Treatment in Phoenix?

Join others in Arizona exploring innovative treatment options through clinical research

Hypertrophic Cardiomyopathy Treatment Options in Phoenix, Arizona

If you're searching for Hypertrophic Cardiomyopathy treatment in Phoenix, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Phoenix, Los Angeles, Los Angeles and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Hypertrophic Cardiomyopathy. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Arizona
Now Enrolling
Up to 40 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Hypertrophic Cardiomyopathy?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Hypertrophic Cardiomyopathy

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Hypertrophic Cardiomyopathy Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06412666. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.