Aficamten for Hypertrophic Cardiomyopathy
(CMI-SWITCH Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment approach for individuals with obstructive hypertrophic cardiomyopathy (oHCM), a condition where the heart muscle thickens, making it harder for the heart to pump blood. Researchers aim to determine if patients can safely switch from their current medication, mavacamten, to a new medication called aficamten, a potential new drug for oHCM. They seek to establish if this switch is both safe and effective. This trial targets individuals diagnosed with oHCM who experience significant heart blockage and are currently taking mavacamten. As a Phase 4 trial, this research focuses on understanding how the already FDA-approved treatment benefits more patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does require that you are currently taking mavacamten. It seems like you will continue with mavacamten as you transition to aficamten.
What is the safety track record for aficamten?
Research has shown that aficamten is generally safe for people with obstructive hypertrophic cardiomyopathy (oHCM). In one study, 282 patients took daily doses of aficamten, ranging from 5 to 20 mg, and researchers found it to be safe. Most patients did not experience serious side effects. Another review of several trials confirmed that aficamten effectively treats oHCM symptoms and is safe. Long-term studies also support its safety, indicating that patients can use aficamten for extended periods without major issues. Overall, evidence shows that aficamten is safe and well-tolerated by patients with oHCM.12345
Why are researchers enthusiastic about this study treatment?
Aficamten is unique because it offers a fresh approach to treating hypertrophic cardiomyopathy by specifically targeting cardiac myosin. Unlike standard treatments that may focus on symptom management or reducing heart workload, aficamten directly modulates the heart's contractility to address the underlying hypercontractility of the disease. Researchers are excited about aficamten because its precise mechanism of action promises to improve heart function and patient outcomes more effectively than current options.
What is the effectiveness track record for aficamten in treating hypertrophic cardiomyopathy?
Research has shown that aficamten, the investigational treatment in this trial, may help treat obstructive hypertrophic cardiomyopathy (oHCM). Studies have found that patients experience significant improvements in their symptoms and exercise capacity. Aficamten reduces the strength of heart muscle contractions, helping to clear the blockage in the heart. Data from clinical trials indicate it can lower heart pressure and enhance patients' quality of life. These findings suggest aficamten is a safe and effective way to manage oHCM symptoms.56789
Are You a Good Fit for This Trial?
This trial is for people with obstructive hypertrophic cardiomyopathy (oHCM) who currently take mavacamten, have significant heart obstruction (≥50 mmHg), and a normal heart pumping function. Participants must be willing to join the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Transition
Participants transition from mavacamten to aficamten, starting at week 2
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Aficamten
Trial Overview
The study tests how safe and effective it is to switch patients from mavacamten to another medication called aficamten for treating oHCM. It takes place at two centers.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Switching from mavacamten on day 1 to aficamten starting at week 2.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Oregon Health and Science University
Lead Sponsor
Saint Lukes Hospital Mid America Heart Institute
Collaborator
Cytokinetics
Industry Sponsor
Citations
Press Releases
Cytokinetics Announces Positive Topline Results from ACACIA-HCM, the Pivotal Phase 3 Clinical Trial of Aficamten in Patients with Non- ...
Efficacy and safety of long-term treatment with aficamten in ...
Efficacy and safety of long-term treatment with aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy: results from ...
Efficacy of Aficamten in Hypertrophic Cardiomyopathy ...
This sub-analysis of SEQUOIA-HCM (NCT05186818) evaluated the efficacy and safety of aficamten in obstructive hypertrophic cardiomyopathy (oHCM) and ...
Safety and Efficacy of Mavacamten and Aficamten in ...
In this review, we evaluated the pharmacologic profile and clinical outcomes for mavacamten and aficamten, 2 cardiac myosin inhibitors investigated in ...
5.
ohsu.elsevierpure.com
ohsu.elsevierpure.com/en/publications/impact-of-aficamten-on-disease-and-symptom-burden-in-obstructive-/Impact of Aficamten on Disease and Symptom Burden in ...
The clinical efficacy of aficamten across multiple outcome domains in oHCM has not been fully defined. Objectives: This responder analysis from ...
Dosing and Safety Profile of Aficamten in Symptomatic ...
A total of 282 patients with obstructive hypertrophic cardiomyopathy were randomized 1:1 to daily aficamten (5–20 mg) or placebo between ...
Dosing and Safety Profile of Aficamten in Symptomatic ...
A site-based dosing algorithm targeting the lowest effective aficamten dose reduced left ventricular outflow tract gradient with a favorable safety profile ...
Efficacy And Safety Of Aficamten In Hypertrophic ...
We conducted a pooled analysis of trials on the efficacy and safety of Aficamten for HCM. Method. This meta-analysis follows the Preferred Reporting Items for ...
Cytokinetics Presents New Data Relating to Aficamten and ...
Two New Analyses from SEQUOIA-HCM Demonstrate Treatment with Aficamten Improves Post-Exercise Oxygen Uptake Recovery and Quality of Life.
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