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NCT05981092
A Study About the Natural History in Adults With BAG3 Dilated Cardiomyopathy (a Type of Heart Disease) (BAG3 DCM)
trial in Cardiomyopathy, Dilated in 35 participants. Participants enrolled and being followed up; not accepting new ones.
12 August 2027
Quick facts
| Lead sponsor | Alexion Pharmaceuticals, Inc. |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 35 |
| Start date | 14 October 2022 |
| Primary completion | 12 August 2027 |
| Estimated completion | 12 August 2027 |
| Sites | 15 locations across Netherlands, United Kingdom, Poland, United States, Spain |
Conditions studied
- Cardiomyopathy, Dilated — all drugs for Cardiomyopathy, Dilated →
- Bcl-2 Anathogene-3 (BAG3) Dilated Cardiomyopathy (DCM) — all drugs for Bcl-2 Anathogene-3 (BAG3) Dilated Cardiomyopathy (DCM) →
Sponsor
Alexion Pharmaceuticals, Inc. — full company profile →
Who can join
18 and older, any sex, with Cardiomyopathy, Dilated or Bcl-2 Anathogene-3 (BAG3) Dilated Cardiomyopathy (DCM). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Pathophysiology of dilated cardiomyopathy: from mechanisms to precision medicine.
Gigli M, Stolfo D, Merlo M, Sinagra G, et al · · 2025 · cited 35× · PMID 39394525 · DOI 10.1038/s41569-024-01074-2
Verify or expand the search:
- PubMed search for NCT05981092
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cardiomyopathy, Dilated
Currently open trials in the same condition.
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- NCT07527715 — Cardiac Magnetic Resonance-Clinical Prediction Model-Dilated Cardiomyopathy · recruiting
- NCT04225520 — AMEND-CRT: Mechanical Dyssynchrony as Selection Criterion for CRT · NA · active not recruiting
Other Alexion Pharmaceuticals, Inc. trials
Trials by the same sponsor.
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- NCT07221838 — A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab · Phase 4 · recruiting
- NCT07413250 — Assess Long-Term Safety of Danicopan Add-on Therapy in Participants With Paroxysmal Nocturnal Hemoglobinuria: Analysis o · active not recruiting
- NCT07308574 — Post-Marketing Clinical Study of Ravulizumab in Participants With Clinical aHUS · Phase 4 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05981092 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Alexion Pharmaceuticals, Inc.
- Last refreshed: 11 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05981092.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing