Clinical trial for Ischemic Heart Failure
Official title CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction
ClinicalTrials.gov ID: NCT06258447
What this study is testing
- What it's testing
- This study is testing whether the CardiAMP cell therapy system is safe and how well it works for people with ischemic heart failure.
- Who it's for
- You may be able to join if you have heart failure caused by blocked arteries and are not in a severe or unstable condition.
- What's involved
- You will receive a small amount of your own bone marrow cells that are processed and injected into your heart. You will also have a control procedure that looks similar but does not use the cells.
- Time commitment
- The study lasts about 6 months, with several hospital visits for treatment, tests, and follow‑up check‑ins.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 90
You may be able to join if
- New York Heart Association (NYHA) Class II or III
- Diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI) as described in the study protocol.
- Left ventricular ejection fraction \>20% and \<40%
- On stable evidence-based medical and device therapy for ischemic etiology heart failure per the ACC/AHA Heart Failure guidelines, for at least three...
- NTproBNP level of \>500 pg/ml
You likely can't join if
- Selected study criteria as defined in the study protocol indicating that patient is not an optimal candidate for cardiac catheterization or...
See the full eligibility criteria
- New York Heart Association (NYHA) Class II or III
- Diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI) as described in the study protocol.
- Left ventricular ejection fraction \>20% and \<40%
- On stable evidence-based medical and device therapy for ischemic etiology heart failure per the ACC/AHA Heart Failure guidelines, for at least three (3) months prior to randomization.
- NTproBNP level of \>500 pg/ml
- Autologous cell analysis score consistent with study selection assessment
- Selected study criteria as defined in the study protocol indicating that patient is not an optimal candidate for cardiac catheterization or intramyocardial delivery of autologous bone marrow mononuclear cells.
The study team makes the final eligibility decision.
Where it is enrolling
- Clearwater, Florida, United States
- Atlanta, Georgia, United States
- Detroit, Michigan, United States
- Madison, Wisconsin, 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, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Clearwater, Florida, United States; Atlanta, Georgia, United States; Detroit, Michigan, United States; Madison, Wisconsin, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.