🏛️ Verified NIH Record • Updated 2026-06-10

A Study About the Natural History in Adults With BAG3 Dilated Cardiomyopathy (a Type of Heart Disease) (BAG3 DCM) (NCT05981092)

A PROSPECTIVE MULTINATIONAL STUDY OF THE NATURAL HISTORY OF PARTICIPANTS WITH BAG3 MUTATION ASSOCIATED DILATED CARDIOMYOPATHY

🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Alexion Pharmaceuticals, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Research Site — Palo Alto, California

Age range: 18 Years

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Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (15 Sites)

  • Research Site — Palo Alto, California
  • Research Site — Aurora, Colorado
  • Research Site — Boston, Massachusetts
  • Research Site — Rochester, Minnesota
  • Research Site — The Bronx, New York
  • Research Site — Philadelphia, Pennsylvania
  • Research Site — Amsterdam, Amsterdam
  • Research Site — Maastricht, Maastricht
  • Research Site — Warsaw, Warszawa
  • Research Site — A Coruña, A Coruna
  • Research Site — Madrid, Madrid
  • Research Site — Majadahonda, Madrid
  • Research Site — El Palmar, Murcia
  • Research Site — Harefield, London
  • Research Site — London, London

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Cardiomyopathy, Dilated clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗