All studies
RecruitingOBSERVATIONAL

A Prospective Registry Study to Assess Real-world Patient Characteristics, Treatment Patterns, and Longitudinal Outcomes in Patients Receiving Mavacamten and Other Treatments for Symptomatic Obstructive Hypertrophic Cardiomyopathy (Obstructive-HCM)

This study is gathering information on people living with a heart condition called obstructive hypertrophic cardiomyopathy (HCM). Researchers want to understand how this condition is treated in everyday medical practice, particularly looking at a new medication called mavacamten, compared to other common treatments, or no treatment if previous options haven't worked. They are interested in seeing how patients' health changes over time, their experience with different treatments, and how safe and effective these treatments are. The study is particularly looking at this in the US and Europe to gather real-world data and help doctors make the best treatment choices for patients with HCM.

At a glance

Status
Recruiting
Sponsor
Bristol-Myers Squibb
Enrolment target
1,600
Start
16 Aug 2022
Estimated completion
17 Aug 2029

What is this study about?

This study is exploring a heart condition called obstructive hypertrophic cardiomyopathy, or obstructive HCM for short. This is when the heart muscle becomes unusually thick, making it harder for the heart to pump blood effectively to the rest of the body. This can cause symptoms like shortness of breath, chest pain, or feeling lightheaded.

The main goal of this research is to understand how people with obstructive HCM are treated in their everyday lives, outside of strict research settings. Doctors want to see how patients respond to a newer medication called mavacamten, as well as to more traditional treatments or even when no treatment is being given due to side effects or if other options haven't helped. By collecting this 'real-world' information, the study aims to get a clearer picture of who gets which treatments, how well these treatments work over time, and if there are any safety concerns.

Ultimately, the information gathered from this study will help healthcare professionals better understand the journey of patients with obstructive HCM. This knowledge can then be used to improve treatment plans, guide important decisions for patients, and ensure they receive the most appropriate and effective care tailored to their individual needs.

Key takeaways

  • This study gathers real-world information on living with obstructive HCM.
  • It compares a new medicine (mavacamten) with other common treatments.
  • The goal is to understand treatment patterns, how patients feel, and long-term results.
  • Participation involves sharing medical information from your routine care.
  • It helps doctors make better treatment choices for patients with HCM.
  • Your medical care will not be affected by joining the study.

Who may be eligible?

To join this study, you need to be at least 18 years old and willing to provide your consent to take part. This study is specifically for people who have been diagnosed with obstructive hypertrophic cardiomyopathy (HCM).

In the UK, this diagnosis would typically follow guidelines from leading heart organisations. Your heart's main pumping chamber (left ventricle) would need to be thicker than usual, and there would be a blockage making it harder for blood to leave your heart (known as a 'gradient'). Your heart's pumping ability should be generally strong, and you should be experiencing symptoms like shortness of breath or chest pain.

As for your current treatment, you might already be taking medicines like beta-blockers, calcium channel blockers, or disopyramide, or starting mavacamten. You might also be eligible if you're not currently on treatment because previous medicines haven't worked for you or you couldn't tolerate them.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years or older?
  2. Do you have a diagnosis of obstructive hypertrophic cardiomyopathy (HCM)?
  3. Are you experiencing symptoms related to your HCM?
  4. Are you currently on treatment for HCM (like beta-blockers, calcium channel blockers, disopyramide, or mavacamten) or unable to tolerate previous treatments?
Answer every question to see your result.

What does participation involve?

As a 'registry study', participation primarily involves allowing researchers to collect information from your routine medical records over time. This means there likely aren't extra visits or procedures specifically for the study. Instead, researchers would track your health status, how your obstructive HCM is managed, the treatments you receive (like mavacamten or other medications), and how your condition progresses during your regular hospital or clinic appointments. This allows them to understand real-world treatment patterns and outcomes without directly interfering with your care. The total duration of your participation would depend on how long the study continues to collect follow-up data.

Potential risks and benefits

Taking part in this study may offer the benefit of contributing to a better understanding of obstructive HCM and its treatments, potentially helping future patients. However, there are no direct benefits to your personal health, as this is an observational study and your treatment would remain guided by your own doctor. Because this study primarily collects existing health information, the risks are minimal, mainly related to data privacy. All efforts will be made to protect your personal information. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (99)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Alaska Heart Institute
    Verified postcode
    Anchorage, United States· Recruiting
  • Pima Heart and Vascular
    Verified postcode
    Tucson, United States· Recruiting
  • UAMS
    Verified postcode
    Little Rock, United States· Recruiting
  • UC San Diego School of Medicine
    Verified postcode
    La Jolla, United States· Recruiting
  • Keck School of Medicine of USC-Usc
    Verified postcode
    Los Angeles, United States· Recruiting
  • Stanford Health Care Hospital & Clinics
    Verified postcode
    Palo Alto, United States· Recruiting
  • University Of California San Francisco Medical Center
    Verified postcode
    San Francisco, United States· Recruiting
  • UC Denver, AMC
    Verified postcode
    Aurora, United States· Recruiting
  • Hartford HealthCare
    Verified postcode
    Hartford, United States· Recruiting
  • MedStar Washington Hospital Center
    Verified postcode
    Washington D.C., United States· Recruiting
  • Uf Health Jacksonville
    Verified postcode
    Jacksonville, United States· Recruiting
  • University of Hawaii Cancer Center
    Verified postcode
    Honolulu, United States· Recruiting

Common questions

What is obstructive hypertrophic cardiomyopathy (HCM)?

It's a heart condition where the heart muscle is unusually thick, making it harder for your heart to pump blood effectively and causing symptoms like breathlessness.

What is mavacamten?

Mavacamten is a newer medicine specifically designed to treat obstructive HCM.

Will I have to change my current treatment if I join?

No, this study observes how you are treated in real life. Your doctor will continue to make all decisions about your care and medication.

Will I have extra appointments?

Because this is a registry study, it's unlikely you'll have extra appointments. Information will mostly be collected from your routine medical visits.

Is this a trial where I might get a placebo?

No, this is not a traditional drug trial where you might get a placebo. It's an observational study looking at existing real-world treatments.

How to find out more

BMS Study Connect Contact Center www.BMSStudyConnect.com

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Prospective Registry Study to Assess Real-world Patient Ch…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.