Regression of Fibrosis & Reversal of Diastolic Dysfunction in HFPEF Patients Treated With Allogeneic CDCs (Regress-HFpEF)
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|ClinicalTrials.gov Identifier: NCT02941705|
Recruitment Status : Recruiting
First Posted : October 21, 2016
Last Update Posted : March 18, 2021
Perform a randomized, double blind, placebo-controlled Phase 2a feasibility study to determine whether treatment of HFPEF patients with intracoronary allogeneic CDCs affects clinical functional status (QOL scores), exercise tolerance (6MHW), exercise hemodynamics (supine exercise ergometry during right heart catheterization), myocardial interstitial fibrosis (MRI with native T1 mapping and calculation of extracellular volume [ECV] after gadolinium administration), macroscopic fibrosis by delayed gadolinium enhancement (DGE), and diastolic function (catheterization, echocardiography, BNP).
Treatment of patients with symptomatic hypertensive heart disease-induced HFPEF with allogeneic CDCs will be safe and will improve clinical functional status, exercise tolerance/hemodynamics, myocardial interstitial structure, and diastolic function; the mechanisms underlying these improvements will be reflected in changes in plasma biomarkers that indicate a reduction in pro-inflammatory and pro-fibrotic signaling.
|Condition or disease||Intervention/treatment||Phase|
|Congestive Heart Failure Heart Failure, Diastolic||Biological: Allogeneic Derived Cells Biological: Placebo/Control Arm||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Regress-HFPEF: Regression of Fibrosis & Reversal of Diastolic Dysfunction in HFPEF Patients Treated With Allogeneic CDCs|
|Actual Study Start Date :||July 12, 2017|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2022|
Active Comparator: RECIEVED CELLS
this arm will receive the CDCs /CAP 1002 solution
Biological: Allogeneic Derived Cells
patients will have the CAP-1002 solution delivered through a coronary catheter inserted in the right and left coronary arteries using standard techniques in the cardiac catheterization laboratory. A right heart catheter will be used to obtain baseline (pre-infusion) hemodynamics.
Other Name: CAP-1002
Placebo Comparator: CONTROL ARM
this arm will receive a solution during randomization but will not receive the CDCs
Biological: Placebo/Control Arm
patients will receive the placebo through a coronary catheter inserted in the right and left coronary arteries using standard techniques in the cardiac catheterization laboratory. A right heart catheter will be used to obtain baseline (pre-infusion) hemodynamics.
Other Name: Placebo
- the safety profile of CAP 1002; any subjects experiencing any safety related events during or post intracoronary delivery and during the follow up period. [ Time Frame: three years ]
any subjects experiencing any safety related events during or post intracoronary delivery and during the follow up period.
Safety outcomes will be measured through TIMI flow 0-2, acute myocarditis within one month of intracoronary infusion, ventricular tachycardia or ventricular fibrillation within 72 hours of intracoronary infusion, sudden unexpected death within 72 hours of intracoronary infusion defined as occurring 1 hour within in symptom onset or witnessed death in a subject previously observed to be well within the preceding 24 hours without an identified cause, or a major adverse cardiac event within 72 hours of intracoronary infusion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02941705
|Contact: Melissa Lamicqfirstname.lastname@example.org|
|Contact: Renee Baxley, RNemail@example.com|
|United States, South Carolina|
|Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Contact: Melissa Lamicq 843-876-5783 firstname.lastname@example.org|
|Contact: Renee Baxley, RN 843-792-1105 email@example.com|
|Principal Investigator: Michael Zile, MD|
|Principal Investigator:||Michael Zile, MD||Medical University of South Carolina|