Myocardial Telomere Recapping Study for Dilated Cardiomyopathy (NCT05837143) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Myocardial Telomere Recapping Study for Dilated Cardiomyopathy
China12 participantsStarted 2023-03-30
Plain-language summary
The aim of this study is to determine the safety and feasibility of giving an adeno-associated viral vector expressing a modified telomerase protein (TERT), driven by cardiac troponin T promoter (AAV9-cTnT-modTERT), to 12 dilated cardiomyopathic patients.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* DCM≥1year;
* NYHA II-IV;
* LVEF ≤35%;
* Received maximally tolerated guideline-directed medical therapy (GDMT) for at least 3 months before enrollment with persistent heart failure; or unable to tolerate standardized pharmacotherapy recommended by guidelines (according to clinical data), but in which investigators assessed participants who could benefit from the study drug; or hospitalized for heart failure more than 2 times within 1 year and requiring intravenous diuretic therapy, while the condition is stable for more than 2 weeks;
* Have the ability to understand and voluntarily sign informed consent before the trial, and be able to complete the study in accordance with the requirements of the trial protocol;
* Male or female: (1) male subjects must agree to use contraception for at least 6 months after treatment visit; (2) the female subjects were not pregnant or breastfeeding; (3) Females of childbearing potential agree to comply with contraceptive guidance for at least 6 months after administration (see Appendix 1)
Exclusion Criteria:
* Patients with heart failure caused by heart diseases other than dilated cardiomyopathy (including but not limited to severe valvular heart disease, hyperthyroidism, congenital heart disease, acute viral myocarditis, acute coronary syndrome, hypertrophic obstructive cardiomyopathy, pericardial disease, myocardial amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease, or left ventricular aneurysm).
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What they're measuring
1
Dose-limiting toxicity (DLT) within 28 days of a single intracoronary infusion of JV001
Timeframe: 28 days
2
Incidence of adverse events and serious adverse events within 1 year of administration