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NCT05981092 · ClinicalTrials.gov registry record
A Study About the Natural History in Adults With BAG3 Dilated Cardiomyopathy (a Type of Heart Disease) (BAG3 DCM)
A clinical trial of Cardiomyopathy, Dilated and Bcl-2 Anathogene-3 (BAG3) Dilated Cardiomyopathy (DCM), sponsored by Alexion Pharmaceuticals.
- Active
- Registry status
- 35
- Enrollment target
- 15
- Study locations
NCT05981092 is a study of Cardiomyopathy, Dilated and Bcl-2 Anathogene-3 (BAG3) Dilated Cardiomyopathy (DCM) that is active but no longer recruiting, run by Alexion Pharmaceuticals. The registered enrollment target is 35 participants. The trial reports 15 study locations across 10 states.
The verdict
NCT05981092, a study of Cardiomyopathy, Dilated and Bcl-2 Anathogene-3 (BAG3) Dilated Cardiomyopathy (DCM), is active but no longer recruiting, sponsored by Alexion Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- 35 participants
- Enrollment target
- 15
- Study locations
Study Summary
The purpose of this study is to learn about the natural progression of DCM (dilated cardiomyopathy) caused by BAG3 gene mutations. DCM is a condition as the heart muscle is weakened and the heart becomes enlarged. This makes it hard for the heart to pump enough blood for the body. The study is seeking up to about 35 participants who have: * BAG3 mutation (change in the gene) that causes or is likely to cause dilated cardiomyopathy * NYHA (New York Heart Association) Class I-IV at screening (Stage B-D) * Left Ventricular Ejection Fraction less than or equal to 50% (meaning reduced heart function) All participants in this study will receive their usual treatment. The investigators will observe the natural progression of people who have BAG3 DCM. This will help the investigators better understand the disease and aid in future research. Participants will take part in this study for three years. During this time, participants will visit the site at least 8 times (about every 3 months for the first year and annually during year 2 and three). Participants will undergo study procedures and give information about their health. These procedures will include a physical exam, cardiac magnetic resonance imaging, echocardiography, ECG monitoring, activity monitoring, cardiopulmonary exercise testing, and blood tests. Participants will answer questions about health and quality of life. The study team will also call participants about 1 time over the phone.
Conditions Studied
Study Locations (15)
Other
- Research Site - Amsterdam
- Research Site - Maastricht
- Research Site - Warsaw
- Research Site - A Coruña
- Research Site - Madrid
- Research Site - London
California
- Research Site - Palo Alto
Colorado
- Research Site - Aurora
Massachusetts
- Research Site - Boston
Minnesota
- Research Site - Rochester
New York
- Research Site - The Bronx
Pennsylvania
- Research Site - Philadelphia
Madrid
- Research Site - Majadahonda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2022-10-14 |
| Est. Completion | 2027-08-12 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05981092
The ClinicalTrials.gov registry entry for NCT05981092 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alexion Pharmaceuticals, which has 162 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cardiomyopathy, Dilated appearing as the primary indexed condition, and to 0 interventions.
NCT05981092 reports 15 study locations spanning 10 distinct geographic areas - top geographies include Other, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT05981092 about?
NCT05981092 is a clinical study titled "A Study About the Natural History in Adults With BAG3 Dilated Cardiomyopathy (a Type of Heart Disease) (BAG3 DCM)". The purpose of this study is to learn about the natural progression of DCM (dilated cardiomyopathy) caused by BAG3 gene mutations. DCM is a condition as the heart muscle is weakened and the heart becomes enlarged. This makes it hard for the heart to pump enough blood for the body. The study is seek...
What is the current status of trial NCT05981092?
This trial is currently active not recruiting. The enrollment target is 35 participants. The study started on 2022-10-14. Estimated completion is 2027-08-12.
What conditions does trial NCT05981092 study?
This clinical trial studies the following conditions: Cardiomyopathy, Dilated, Bcl-2 Anathogene-3 (BAG3) Dilated Cardiomyopathy (DCM).
Who is sponsoring clinical trial NCT05981092?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05981092 being conducted?
This trial has 15 study locations across California, Colorado, Massachusetts, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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