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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 : January 30, 2020
Sponsor:
Collaborator:
Medical University of South Carolina
Information provided by (Responsible Party):
Eduardo Marbán, MD, PhD, Cedars-Sinai Medical Center

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 : December 2020
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ≥ 50 years old, male or female
  2. LVEF ≥ 50%
  3. Symptoms and physical findings of chronic heart failure (NYHA class II- ambulatory IV)
  4. Treatment with a stable, maximally-tolerated dose of diuretic(s) for a minimum of 30 days prior to randomization.
  5. Left atrial (LA) enlargement defined by at least one of the following: LA width (diameter) ≥ 3.8 cm or LA length ≥ 5.0 cm or LA area ≥ 20 cm2 or LA volume ≥ 55 mL or LA volume index ≥ 29 mL/m2
  6. BNP > 125 pg/ml for patients in NSR or > 150 pg/ml for patients in AF (BNP are BMI corrected) or resting PCWP > 15 mmHg, or exercise PCWP > 18 mmHg

Exclusion criteria-Specific to HFPEF

  1. Any prior echocardiographic measurement of LVEF < 40 %
  2. Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery, or percutaneous coronary intervention (PCI) within the 3 months prior to randomization
  3. Unrevascularized, hemodynamically significant CAD (FFR < 0.75)
  4. Current acute decompensated HF
  5. Alternative diagnoses that in the opinion of the investigator could account for the patient's HF symptoms (i.e., dyspnea, fatigue) such as severe pulmonary disease (i.e., requiring home oxygen, chronic nebulizer therapy, chronic oral steroid therapy); hemoglobin (Hgb) < 10 g/dl; body mass index (BMI) > 40 kg/m2
  6. Use of investigational drugs or treatments at the time of enrollment
  7. Systolic blood pressure > 150 mmHg but < 180 mmHg unless receiving 3 or more antihypertensive drugs
  8. History of any dilated cardiomyopathy; right sided HF in the absence of left-sided structural heart disease; Pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy; clinically significant congenital heart disease; hemodynamically significant valvular heart disease
  9. Stroke, transient ischemic attack, carotid surgery or carotid angioplasty within the 3 months
  10. Uncontrolled dysrhythmia; symptomatic or sustained ventricular tachycardia or atrial fibrillation or flutter with a resting ventricular rate > 110 beats per minute (bpm)
  11. Prior major organ transplant or intent to transplant (i.e., on transplant list)
  12. Hepatic disease as determined by any one of the following: SGOT (AST) or SGPT (ALT) values exceeding 3x the upper limit of normal (ULN), bilirubin > 1.5 mg/dl; history of chronic viral hepatitis
  13. Chronic Kidney Disease with eGFR < 30 mL/min/1.73 m2; serum potassium > 5.5 mmol/L (mEq/L)
  14. History or presence of any other disease with a life expectancy of < 3 years
  15. Non-compliance to medical regimens
  16. Drug or alcohol abuse within the last 12 months
  17. History of malignancy within the past 5 years
  18. Pregnant or nursing (lactating) women confirmed by a positive human chorionic gonadotropin (hCG); women of child-bearing potential (physiologically capable of becoming pregnant), unless using highly effective contraception methods during study

Exclusion criteria-Specific to CAP-1002 (not listed above)

  1. Diagnosis of active myocarditis
  2. Known hypersensitivity to contrast agents or previous H/O HIT
  3. Known hypersensitivity to dimethyl sulfoxide (DMSO)
  4. Known hypersensitivity to bovine products
  5. Active infection not responsive to treatment
  6. Active allergic reactions, connective tissue diseases or autoimmune disorders
  7. History of cardiac tumor or cardiac tumor demonstrated on screening
  8. History of previous stem cell therapy
  9. History of treatment with immunosuppressive agents, including chronic systemic corticosteroids, biologic agents targeting the immune system, anti-tumor and anti-neoplastic drugs or anti-VEGF within 6 months prior to enrollment (not including drug-eluting coronary stents)
  10. Human Immunodeficiency Virus (HIV) infection

Information from the National Library of Medicine

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


Contacts
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Contact: Melissa Lamicq 843-876-5783 lamicq@musc.edu
Contact: Renee Baxley, RN 843-792-1105 baxleyr@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Melissa Lamicq    843-876-5783    lamicq@musc.edu   
Contact: Renee Baxley, RN    843-792-1105    baxleyr@musc.edu   
Principal Investigator: Michael Zile, MD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Medical University of South Carolina
Investigators
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Principal Investigator: Michael Zile, MD Medical University of South Carolina
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Responsible Party: Eduardo Marbán, MD, PhD, Director, Heart Institute, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02941705    
Other Study ID Numbers: 54823
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eduardo Marbán, MD, PhD, Cedars-Sinai Medical Center:
stem cell research
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases