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Cell Therapy in HFpEF (CELLpEF)

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.
 
ClinicalTrials.gov Identifier: NCT02923609
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Bojan Vrtovec, University Medical Centre Ljubljana

Brief Summary:

The primary objective of the study is to investigate safety and efficacy of transendocardial CD34+ cell therapy in patients with HFpEF by evaluating changes in myocardial structure and function, myocardial perfusion and electrical activity, biomarkers of neurohormonal activation, patient exercise capacity and clinical outcome.

The secondary objective of the study is to better define the patophysiological background of HFpEF by the use of multimodality imaging platform, which will include data from electro-anatomical mapping, cardiac MRI, 2D and 3D echocardiography, high resolution electrocardiography, and cardiac catheterization


Condition or disease Intervention/treatment Phase
Heart Failure With Normal Ejection Fraction Biological: Cell Therapy Biological: Control Procedure Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A PILOT TRIAL OF CELL THERAPY IN HEART FAILURE WITH PRESERVED EJECTION FRACTION
Actual Study Start Date : January 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: SC Group
After enrollment, all patients will receive 5-day stem cell mobilization with G-CSF. Thereafter, patients will be randomly allocated to either active (SC Group) or control group (Controls) in a 2:1 ratio. Patients in the SC Group will undergo apheresis; CD34+ cells will be collected with immunomagnetic selection, and delivered transendocardialy in the target areas defined by electroanatomical mapping.
Biological: Cell Therapy
Electro-anatomical mapping will be performed using the Biosense NOGA system (Biosense-Webster, Diamond Bar, California). Local diastolic function will be assessed by a novel algorhithm that allows for the measuring local ventricular relaxation times at each of the sampling points. Target areas for cell delivery will be defined as the myocardial segments with the evidence of local diastolic dysfunction and myocardial hibernation. Transendocardial delivery of cell suspension in the SC Group will be performed with MyoStar® (Biosense Webster) injection catheter. Each patient will receive 20 injections of 0.3 mL of stem cell suspension.

Placebo Comparator: Control
In the Control group, no apheresis or immunomagnetic selection of CD34+ cells will be performed; the patients will receive transendocardial injections of placebo using the same electroanatomical mapping protocol as in patients from the SC Group.
Biological: Control Procedure
In the Control Group we will perform transendocardial injections using the same protocol as in the SC Group; stem cell suspension will be substituted with placebo (0.9% saline).




Primary Outcome Measures :
  1. Change in diastolic function (E/e') assessed by cMRI [ Time Frame: Baseline and 1 year ]

Secondary Outcome Measures :
  1. Change in exercise capacity [ Time Frame: Baseline and 1 year ]
  2. Change in NT-proBNP levels [ Time Frame: Baseline and 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Preserved left ventricular systolic function on echocardiography (LVEF>50%)
  • Evidence of diastolic dysfunction by echocardiography (E/e'>15)
  • Symptoms of heart failure (NYHA functional class II or III)
  • NT-proBNP levels >300 pg/ml

Exclusion Criteria:

  • Acute multi-organ failure
  • History of any malignant disease within 5 years
  • Diminished functional capacity due to non-cardiac co-morbidities (COPD, PAOD, morbid obesity)
  • Pregnancy

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): NCT02923609


Contacts
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Contact: Bojan Vrtovec, MD, PhD +3861 522 1157 bojan.vrtovec@gmail.com
Contact: Martina Jaklic, PhD +3861 522 1148 martina.jaklic@kclj.si

Locations
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Slovenia
University Medical Center Ljubljana Recruiting
Ljubljana, Slovenia, 1000
Contact: Bojan Vrtovec, MD, PhD    +3861 522 1157    bojan.vrtovec@gmail.com   
Contact: Martina Jaklic, PhD       martina.jaklic@kclj.si   
Principal Investigator: Bojan Vrtovec, MD, PhD         
Sponsors and Collaborators
University Medical Centre Ljubljana

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Responsible Party: Bojan Vrtovec, Medical Director, Advanced Heart Failure and Transplantation Programme, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02923609    
Other Study ID Numbers: CELLpEF
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases