AB-1002 in Patients With Class III Heart Failure (NCT04179643) | Clinical Trial Compass
CompletedPhase 1
AB-1002 in Patients With Class III Heart Failure
United States11 participantsStarted 2019-11-20
Plain-language summary
This is a Phase 1, prospective, multi-center, open-label, sequential dose escalation study to explore the safety, feasibility, and efficacy of a single intracoronary infusion of AB-1002 in patients with NYHA Class III heart failure. 11 participants with non-ischemic cardiomyopathy were enrolled. All participants were followed until 12 months post treatment intervention, and then underwent long-term follow-up via semi-structured telephone questionnaires every 6 months for an additional 24 months (+/- 30 days).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Age \>18 years of age
* Chronic non-ischemic cardiomyopathy
* LVEF 15% ≤ 30% by transthoracic echocardiography (TTE) within 6 months prior to enrollment
* NYHA Class III HF for a minimum of 3 months HF despite appropriate medical therapy (defined below):
* Treatment with appropriate HF therapy as tolerated, including, but not limited to:
* Beta blocker therapy and angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) or sacubitril/valsartan combination therapy (Entresto) for ≥ 90 days prior to enrollment. May also receive aldosterone antagonist therapy. Doses of the above medications must be stable for ≥ 30 days prior to enrollment; and
* Cardiac resynchronization therapy (CRT), if clinically indicated, must have been implanted ≥ 90 days prior to enrollment. Internal cardioverter defibrillator (ICD) must be implanted, if clinically indicated ≥ 30 days prior to enrollment
* Females of childbearing potential must use at least one of the following acceptable birth control methods throughout the study and for 6 months after IP administration:
* Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum prior to IP administration
* Intrauterine device in place for at least 90 days prior to receiving IP
* Barrier methods (diaphragm plus spermicide or condom) starting at least 30 days prior to receiving IP
* Abstinence (the subject must be willing to remain abstinent from screening …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Observed and change from baseline in Peak VO2
Timeframe: Measured at screening, month 6, 9 and month 12
2
Observed and change from baseline in Echocardiographic assessment in Left Ventricular Ejection Fraction
Timeframe: Measured at screening, 18-24 hours post intervention, week 4, Month 3, Month 6 and Month 12