Authorised Therapeutic exploratory (Phase II) Symptomatic hypertrophic cardiomyopathy (HCM)

Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten (CK-3773274) in Adults With Hypertrophic Cardiomyopathy (HCM)

EU CTIS ID: 2023-508963-58-00

What this study is testing

To determine the safety and tolerability of aficamten in patients with symptomatic HCM

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 1. Completion of a Cytokinetics study investigating aficamten. If unable to complete due to circumstances not related to compliance or safety, Medical Monitor may review and determine eligibility.
  • 2. Left ventricular ejection fraction (LVEF) ≥ 55%.

You likely can't join if

  • 1. Has received treatment with mavacamten: (a) within 56 days prior to dosing and (b) has not received approval for participation from the Medical Monitor.
  • 2. Has participated in another investigational device or drug study or received an investigational device or drug < 1 month (or 5 half-lives for drugs, whichever is longer) prior to screening. Other investigational procedures while participating in this study are not permitted.
  • 3. Since completion of a previous study of aficamten has: - Developed new-onset paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) < 30 days prior to screening. Patient may re-screen for CY 6022 after 30 days if heart rate < 100 bpm and/or rhythm is stable > 30 days. - Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation).
  • 4. Had a confirmed LVEF < 40% with an associated dose interruption during participation in a prior study with aficamten.
  • 5. History of implantable cardioverter-defibrillator (ICD) placement within 30 days prior to screening.

The study team makes the final eligibility decision.

Where it's taking place

  • Brazil
  • United Kingdom
  • Israel
  • Canada
  • Argentina
  • United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Brazil; United Kingdom; Israel; Canada; Argentina; United States. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.