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New treatment option for Dilated Cardiomyopathy (DCM)
Official title An AAV Gene Therapy Trial of AFTX-201 in Adults With BAG3-Associated Dilated Cardiomyopathy (DCM)
ClinicalTrials.gov ID: NCT07426419
What this study is testing
What is AFTX-201?
AFTX-201 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for dilated cardiomyopathy (dcm).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 1/2, open-label, dose-exploration and dose-expansion, clinical trial evaluating the safety, tolerability, pharmacodynamics, and preliminary efficacy of a single intravenous infusion of AFTX-201 in adults with dilated cardiomyopathy caused by a BAG3 gene mutation
- Phase 2: a mid-size study of how well it works
- Time commitment: about 60 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- Male or female, 18 to 55 years of age
- Truncating mutation in BAG3
- Dilated cardiomyopathy with left ventricular ejection fraction (LVEF) \< 45%
- NYHA Class II or III heart failure symptoms
- NT-proBNP ≥ 300 pg/mL for people in sinus rhythm or paced rhythm, or ≥ 600 pg/mL for people in atrial fibrillation
You likely can't join if
- Prior myocardial infarction, heart transplant, or presence/requirement of a left ventricular assist device (LVAD)
- IV therapy with positive inotropes, vasodilators, or diuretics for heart failure within 30 days prior to enrollment
- Positive neutralizing antibodies to ATC-0187
- Any condition that, in the investigator's opinion, would place the subject at undue risk or interfere with study participation or interpretation of...
See the full eligibility criteria
- Male or female, 18 to 55 years of age
- Truncating mutation in BAG3
- Dilated cardiomyopathy with left ventricular ejection fraction (LVEF) \< 45%
- NYHA Class II or III heart failure symptoms
- NT-proBNP ≥ 300 pg/mL for people in sinus rhythm or paced rhythm, or ≥ 600 pg/mL for people in atrial fibrillation
- Willing and able to sign informed consent and comply with study procedures
- Prior myocardial infarction, heart transplant, or presence/requirement of a left ventricular assist device (LVAD)
- IV therapy with positive inotropes, vasodilators, or diuretics for heart failure within 30 days prior to enrollment
- Positive neutralizing antibodies to ATC-0187
- Any condition that, in the investigator's opinion, would place the subject at undue risk or interfere with study participation or interpretation of results
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Kansas City, Missouri, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 60 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Kansas City, Missouri, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.