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NCT05489705 · ClinicalTrials.gov registry record
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)
A clinical trial of Obstructive Hypertrophic Cardiomyopathy, sponsored by Bristol-Myers Squibb.
- Recruiting
- Registry status
- 1,600
- Enrollment target
- 20
- Study locations
NCT05489705: Recruiting study of Obstructive Hypertrophic Cardiomyopathy, sponsored by Bristol-Myers Squibb.
NCT05489705 is a study of Obstructive Hypertrophic Cardiomyopathy that is actively recruiting participants, run by Bristol-Myers Squibb. The registered enrollment target is 1,600 participants, above the 154-participant average among 3 other Obstructive Hypertrophic Cardiomyopathy trials with a reported enrollment target (939% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05489705, a study of Obstructive Hypertrophic Cardiomyopathy, is actively recruiting participants, sponsored by Bristol-Myers Squibb.
- RECRUITING
- Registry status
- 1,600 participants
- Enrollment target
- 20
- Study locations
Study Summary
This registry evaluates patient characteristics, real-world treatment patterns, and short- and long-term outcomes in a population of patients in the United States and Europe with symptomatic obstructive hypertrophic cardiomyopathy (HCM) who are receiving mavacamten, receiving other treatment for obstructive HCM, or not receiving treatment for obstructive HCM due to intolerance or failure of prior treatment. United States Sub-Study: The purpose of this study is to evaluate the safety of mavacamten in patients with symptomatic obstructive HCM in the real-world setting. Europe Sub-Study: The purpose of this study is to evaluate the effectiveness and safety of mavacamten in patients with symptomatic obstructive HCM in the real-world setting.
Primary Outcome
Systolic dysfunction defined as symptomatic Left Ventricular Ejection Fraction (LVEF) \< 50%. United States participants only.
Conditions Studied
Interventions
- DRUG Mavacamten
- DRUG Non-mavacamten symptomatic oHCM therapy
Study Locations (20)
California
- UC San Diego School of Medicine - La Jolla
- Keck School of Medicine of USC-Usc - Los Angeles
- Stanford Health Care Hospital & Clinics - Palo Alto
- University Of California San Francisco Medical Center - San Francisco
Indiana
- Indiana. University - Indianapolis
- Franciscan Physician Network-Indiana Heart Physicians - Indianapolis
Maryland
- University Of Maryland, Ihv - Baltimore
- MedStar Health Research Institute - Baltimore
Alaska
- Alaska Heart Institute - Anchorage
Arizona
- Pima Heart and Vascular - Tucson
Arkansas
- UAMS - Little Rock
Colorado
- UC Denver, AMC - Aurora
Connecticut
- Hartford HealthCare - Hartford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,600 participants |
| Start Date | 2022-08-16 |
| Est. Completion | 2029-08-17 |
What NCT05489705 shows while recruiting
NCT05489705 is an observational study that tracks outcomes without assigning an intervention. Its 1,600 participants enrollment target places it among the larger protocols in the corpus, above the 154-participant average among 3 other Obstructive Hypertrophic Cardiomyopathy trials with a reported enrollment target (939% higher).
The record links to 1 condition, with Obstructive Hypertrophic Cardiomyopathy appearing as the primary indexed condition, and to 2 interventions - of which Mavacamten is the first listed.
NCT05489705 names 20 study sites across 15 states, led by California, Indiana, Maryland.
Frequently Asked Questions
What is clinical trial NCT05489705 about?
NCT05489705 is a clinical study titled "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 registry evaluates patient characteristics, real-world treatment patterns, and short- and long-term outcomes in a population of patients in the United States and Europe with symptomatic obstructive hypertrophic cardiomyopathy (HCM) who are receiving mavacamten, receiving other treatment for obs...
What is the current status of trial NCT05489705?
This trial is currently recruiting. The enrollment target is 1,600 participants. The study started on 2022-08-16. Estimated completion is 2029-08-17.
What conditions does trial NCT05489705 study?
This clinical trial studies the following conditions: Obstructive Hypertrophic Cardiomyopathy.
What interventions are being tested in trial NCT05489705?
The interventions under investigation include: Mavacamten (DRUG), Non-mavacamten symptomatic oHCM therapy (DRUG).
Who is sponsoring clinical trial NCT05489705?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05489705 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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