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CardiAMP™ Heart Failure Trial

This study is currently recruiting participants.
Verified February 2017 by BioCardia, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02438306
First Posted: May 8, 2015
Last Update Posted: February 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
BioCardia, Inc.
  Purpose

This is a prospective, multi-center, randomized (3 Treatment : 2 Sham Control), sham-controlled, patient and evaluator-blinded study comparing treatment with the CardiAMP cell therapy to a sham treatment.

A roll-in phase with a maximum of 10 subjects will precede the randomised phase.


Condition Intervention Phase
Heart Failure Biological: Autologous cell therapy Device: CardiAMP cell therapy Other: Sham Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy in Patients With Post Myocardial Infarction Heart Failure (CardiAMP Heart Failure Trial)

Resource links provided by NLM:


Further study details as provided by BioCardia, Inc.:

Primary Outcome Measures:
  • Change in Six (6) Minute Walk Distance at 12 months from baseline [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Overall survival as a non-inferiority outcome [ Time Frame: 12 months ]
  • Freedom from Major Adverse Cardiac Events (composite of all-cause death,hospitalization for worsening heart failure, nonfatal MI, [LVAD], or heart transplantation) as a non-inferiority outcome [ Time Frame: 12 months ]
  • Change in quality of life as measured by Minnesota Living with Heart Failure questionnaire as a superiority outcome [ Time Frame: 12 months ]
  • Time to first MACE as a superiority outcome [ Time Frame: 12 months ]
  • Overall survival as a superiority outcome [ Time Frame: 12 months ]
  • Survival at 2 years [ Time Frame: 24 months ]
  • Heart Failure Death [ Time Frame: 12 months ]
  • Treatment-emergent Serious Adverse Event at 30-days [ Time Frame: 1 month ]
  • Heart Failure Hospitalization [ Time Frame: 12 months ]
  • All-cause Hospitalization [ Time Frame: 12 months ]
  • Days alive out of hospital [ Time Frame: 12 months ]
  • Freedom from Serious Adverse Events [ Time Frame: 12 months ]
  • NYHA Functional Class [ Time Frame: 12 months ]
  • 6 MWD repeated measure analysis [ Time Frame: 12 months ]
  • Echocardiographic measures of change in ejection fraction, left ventricular end systolic and end diastolic volumes, left ventricular end systolic and end diastolic dimensions, mitral regurgitation (composite) [ Time Frame: Baseline ]
  • Technical success defined as successful delivery of ABM MNC, at the time of the procedure [ Time Frame: Baseline ]

Estimated Enrollment: 250
Study Start Date: December 2016
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CardiAMP cell therapy
Treatment with autologous cell therapy.
Biological: Autologous cell therapy Device: CardiAMP cell therapy
Sham Comparator: Sham
Placement of an introducer and performance of LV gram only.
Other: Sham
Optimal medical/device therapy

Detailed Description:

Heart failure is a clinical condition in which the output of blood from the heart is insufficient to meet the metabolic demands of the body. In 2015, the American Heart Association, or AHA, report on heart disease statistics estimated that there are 5.7 million Americans over the age of 20 that have heart failure. Heart failure is increasingly prevalent due to the aging population and the increase in major cardiovascular risk factors, including obesity and diabetes.

The AHA also estimates that one in five adults will develop heart failure after the age of 40. During heart failure progression, the heart steadily loses its ability to respond to increased metabolic demand, and mild exercise soon exceeds the heart's ability to maintain adequate output. Towards the end stage of the disease, the heart cannot pump enough blood to meet the body's needs at rest. At this stage, fluids accumulate in the extremities or in the lungs making the patient bedridden and unable to perform the activities of daily living. The long-term prognosis associated with heart failure is approximately 50% mortality at five years following the initial diagnosis.

CardiAMP is a comprehensive therapeutic treatment that comprises (i) a point of care cell processing platform, and (ii) a biotherapeutic delivery system. CardiAMP is the first comprehensive therapeutic treatment utilizing a patient's own cells for the treatment of ischemic systolic heart failure, which is heart failure that develops after a heart attack. In the screening process, the physician extracts a small sample of the patient's bone marrow in an outpatient procedure performed under local anesthesia. The clinic sends the sample to a centralized diagnostic lab, which tests the sample. During the treatment, a clinician harvests and then prepares the patient's own bone marrow mononuclear cells, or autologous cells, using the CardiAMP point of care cell processing platform, which a cardiologist then delivers into the heart using the Helix biotherapeutic delivery system.

BioCardia intends to submit data obtained from this clinical trial in a Pre-Market Approval Application to the United States Food and Drug Administration

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Greater than (>) 21 and less than (<) 90 years of age.
  • New York Heart Association (NYHA) Class II or III.
  • A diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI).
  • Have an ejection fraction ≥ 20% and ≤ 40%.
  • On stable evidence-based medical and device therapy for heart failure or post-infarction left ventricular dysfunction, per the 2013 ACC/AHA Heart Failure guidelines, for at least three (3) months prior to randomization.
  • Cell Potency Assay Score of 3, as determined by the Cell Analysis Core Lab results.
  • Provide written informed consent.

Exclusion Criteria:

  • Have a baseline glomerular filtration rate <50 ml/min/1.73m2.
  • Have a hematological abnormality as evidenced by hematocrit < 25%, white blood cell < 2,500/ul or platelet values, <100,000/ul without another explanation.
  • Have liver dysfunction, as evidenced by enzymes (AST and LT) greater than three times the ULN.
  • Have a coagulopathy (INR ≥ 1.3) not due to a reversible cause (i.e., Coumadin). Patients on Coumadin will be withdrawn before the procedure and confirmed to have an INR <1.3. Patients who cannot be withdrawn from Coumadin will be excluded from enrollment.
  • Be an organ transplant recipient.
  • Have a clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively-treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma.
  • Be serum positive for hepatitis B/C and or HIV, unless patient is a carrier for Hepatitis B/C, but has never had an active flare.
  • History of bronchospastic lung disease (asthma or chronic obstructive pulmonary disease), orthopedic, muscular or neurologic conditions that could limit the ability to perform 6 Minute Walk Distance Test.
  • Have a known, serious radiological contrast allergy.
  • Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods for at least 30 days prior to randomization.
  • Not a candidate for cardiac catheterization.

Cardiac or Vascular System

  • Require coronary artery revascularization. Patients who require or undergo revascularization procedures would undergo these procedures a minimum of 3 months in advance of randomization.
  • Have a left ventricle thrombus, as detected by the echocardiographic core laboratory.
  • Have mitral regurgitation, defined as "severe", as measured by the echocardiographic core laboratory.
  • Have a mechanical aortic valve or heart constrictive device.
  • Have severe mitral or tricuspid insufficiency.
  • Have a documented presence of aortic stenosis (aortic stenosis graded as > + 2 equivalent to an orifice area of 1.5cm2 or less), as detected by the echocardiographic core laboratory.
  • Have a documented presence of aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥ + 2).
  • Acute coronary syndrome within 3 months.
  • Have evidence of a life-threatening arrhythmia (non-sustained ventricular tachycardia ≥ 20 consecutive beats) or sustained or short run (>20 consecutive beats) ventricular tachycardia during the screening Holter Monitoring.
  • AICD firing in the past 60 days prior to the procedure.
  • Have peripheral artery disease involving the aorta or iliofemoral system that impacts the feasibility or safety of the study intervention. This includes stenotic or aneurysmal or embolic disease, and symptom limiting claudication.
  • Have complete heart block or QTc interval >550 ms on screening 12-lead ECG.

Other

  • Have a non-cardiac condition that limits lifespan to < 1 year.
  • Have a history of drug or alcohol abuse within the past 24 months.
  • Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial or participated in the treatment arm of a gene or stem cell therapy trial within the previous 12 months.
  • Unwilling or unable to comply with follow-up.
  Contacts and Locations
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): NCT02438306


Contacts
Contact: Eric Duckers, MD/PhD 650-226-0120 info@biocardia.com

Locations
United States, Florida
University of Florida - College of Medicine/ div of Cardiovascular Medicine Recruiting
Gainesville, Florida, United States, 32606
Contact: David Anderson, MD    352-265-0111      
Contact: Sarah J Long, MD    352-265-0111      
United States, Maryland
John Hopkins University School of Medicine - dept of Cardiology Recruiting
Baltimore, Maryland, United States
Contact: Peter Johnson, MD    410-955-5000      
Contact: Judi Wilhide, RN    410-955-5000      
United States, Wisconsin
Division of Cardiovascular Medicine, University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792-0001
Contact: Amish Raval, MD    608-263-6400      
Contact: Cathlyn Leitzke, RN    (608) 262-2290    cjl@medicine.wisc.edu   
Sponsors and Collaborators
BioCardia, Inc.
Investigators
Principal Investigator: Carl Pepine, MD University of Florida
Principal Investigator: Amish Raval, MD University of Wisconsin, Madison
  More Information

Additional Information:
Responsible Party: BioCardia, Inc.
ClinicalTrials.gov Identifier: NCT02438306     History of Changes
Other Study ID Numbers: BC-14-001-02
First Submitted: May 5, 2015
First Posted: May 8, 2015
Last Update Posted: February 9, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases