Cell Therapy in HFpEF (CELLpEF)
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|ClinicalTrials.gov Identifier: NCT02923609|
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : April 18, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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).
- Change in diastolic function (E/e') assessed by cMRI [ Time Frame: Baseline and 1 year ]
- Change in exercise capacity [ Time Frame: Baseline and 1 year ]
- Change in NT-proBNP levels [ Time Frame: Baseline and 1 year ]
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
|Contact: Bojan Vrtovec, MD, PhD||+3861 522 firstname.lastname@example.org|
|Contact: Martina Jaklic, PhD||+3861 522 email@example.com|