CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction

Ischemic Heart Failure Clinical Trial

Official title:

Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy System in Patients With Ischemic Heart Failure II Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06258447
• Other study ID #: 05804 (CLIN)
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: April 1, 2029

Study information

• Verified date: February 2024
• Source: BioCardia, Inc.
• Contact: Debby Holmes-Higgin, MS, MPH
• Phone: 650-226-0120
• Email: debbyhh[@]biocardia.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Concentrated autologous bone marrow mononuclear cells (ABM MNC) contain potentially therapeutic cell factors and past studies support therapeutic benefit to patients with cardiac diseases of acute myocardial infarction, ischemia, and heart failure when utilized as this study is designed. The purpose of the study is to determine the safety and efficacy of CardiAMP cell therapy system in patients with ischemic heart failure. It is a prospective, multi-center, randomized, controlled, patient and evaluator-blinded study comparing treatment with the CardiAMP cell therapy system to a control procedure with diagnostic catheterization.

Description:

Chronic heart failure is in need of new therapies. Over the past few years, cardiovascular regenerative medicine using bone marrow derived cells has emerged as a new treatment strategy that could have tremendous benefit in treating heart failure and are well supported by recent meta analyses of early clinical data sets. Concentrated autologous bone marrow mononuclear cells (ABM MNC) are the subject of the current study as they are supported by more clinical data than any other cell type described, and contain all of the potentially therapeutic cell factors from studies of selected cells. Study results demonstrate ABM MNC to be safe, and, when delivered intramyocardially as intended in the current study, results consistently support therapeutic benefit to patients with cardiac diseases of acute myocardial infarction, ischemia, and heart failure. The purpose of the study is to determine the safety and efficacy of CardiAMP cell therapy system in patients with ischemic heart failure. It is a prospective, multi-center, randomized, controlled, patient and evaluator-blinded study comparing treatment with the CardiAMP cell therapy system to a control procedure with diagnostic catheterization. The Treatment Group undergoes left ventricular catheterization and is treated with ABM MNC using the CardiAMP cell therapy system. The Control Group has a Control procedure consisting of left ventricular diagnostic catheterization but no introduction of the Helix transendocardial delivery catheter and no administration of ABM MNC.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: April 1, 2029
• Est. primary completion date: April 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

Inclusion 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Heart Failure
• Ischemia
• Ischemic Heart Failure

Intervention

Device:
• Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system
the ABM MNC is obtained from the study patient via bone marrow aspiration in the hip and processed and delivered using the CardiAMP cell therapy system during the cardiac catheterization.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BioCardia, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Efficacy Endpoint	The primary efficacy endpoint is the comparison of a composite score based on a 3-tiered Finkelstein-Schoenfeld (FS) hierarchical analysis. The tiers, starting with the most serious events, would be (1) all cause death, including cardiac death equivalents such as heart transplant or left ventricular assist device placement, ordered by time to event; (2) non-fatal MACCE events (heart failure hospitalization or a worsening heart failure, stroke or MI) ordered by time to event, excluding those deemed procedure related occurring within the first 7 days, and (3) change for quality of life as measured using the Minnesota Living with Heart Failure Questionnaire (MLwHFQ)	Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months
Secondary	First Secondary Endpoint	Time to all-cause death, LVAD/heart transplant, or heart failure hospitalization	Baseline through study completion, maximum of two years
Secondary	Second Secondary Endpoint	Cumulative heart failure hospitalizations	Baseline through study completion, maximum of two years
Secondary	Third Secondary Endpoint	Time to first heart failure hospitalization	Baseline through study completion, maximum of two years
Secondary	Fourth Secondary Endpoint	Change in quality of life as measured using the MLwHF questionnaire based on a scale of 0-105, with 0 being best.	Baseline to 12 months, 24 months
Secondary	Fifth Secondary Endpoint	Change in quality of life as measured using the Kansas City Cardiomyopathy questionnaire (KCCQ), based on a scale of 0-100, with 100 being best	Baseline to 12 months, 24 months
Secondary	Sixth Secondary Endpoint	Change in functional capacity as measured using the 6-minute walk test (6MWT)	Baseline to 12 months, 24 months
Secondary	Seventh Secondary Endpoint	Modified Primary Efficacy Endpoint consisting of all-cause death, LVAD/heart transplant, heart failure hospitalizations and worsening heart failure events treated as an outpatient but without a quality-of-life measure	Baseline through study completion, maximum of two years