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Completed

NCT Number: NCT02923609

Cell Therapy in HFpEF

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, patient exercise capacity and clinical outcome.

The safety end-points include serious adverse events (SAEs), defined as any serious event that may result in persistent or significant disability or incapacity and included death, heart transplantation, sustained ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation), and heart failure exacerbation requiring hospitalization.

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Key information

Conditions

Heart Failure With Normal Ejection Fraction

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Medical Center Ljubljana

Ljubljana, 1000, Slovenia

About this study

In all patients, peripheral blood stem cells will be mobilized by daily subcutaneous injections of G-CSF (10 mcg/kg, divided b.i.d) for 5 days. Peripheral blood stem cells will then be collected with Miltenyi cell separator (Miltenyi Biotech, Germany) and the magnetic cell separator Isolex 300i (Nexell Therapeutics Inc., California, USA) will be used for the immunomagnetic positive selection of the CD34+ cells.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Preserved left ventricular systolic function on echocardiography (LVEF>50%)
  • Evidence of diastolic dysfunction by echocardiography (E/e'>15)
  • Symptoms of heart failure
  • NT-proBNP levels >300 pg/ml
  • absence of permanent atrial fibrillation

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

Treatment and study plan

Cell therapy

Biological

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.

Primary outcomes

  1. Change in left ventricular filling pressures (E/e') assessed by echocardiography

    Time frame: Baseline, 6 months and 1 year

    The E/e' ratio will be calculated from early transmitral velocity divided by peak left ventricular relaxation velocity for estimation of the left ventricular filling pressure.

Secondary outcomes

  1. Change in exercise capacity

    Time frame: Baseline, 6 months and 1 year

    6-minute walk test will be performed by a blinded observer according to the standard protocol.

  2. Change in NT-proBNP levels

    Time frame: Baseline, 6 months and 1 year

    NT-proBNP assays will be performed at a central independent laboratory, blinded to the patient's clinical data using a commercially available kit (Roche Diagnostics, Mannheim, Germany).

  3. Change in systolic strain

    Time frame: Baseline, 6 months and 1 year

    Left ventricular longitudinal strains will be analyzed by speckle tracking echocardiography from apical four-chamber, two-chamber, and long-axis views.

  4. Change in diastolic dysfunction grade

    Time frame: Baseline, 6 months and 1 year

    Diastolic dysfunction will be graded according based on E/A ratio and left atrial pressure estimation.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

A PILOT TRIAL OF CELL THERAPY IN HEART FAILURE WITH PRESERVED EJECTION FRACTION

Acronym: CELLpEF

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Oct 4, 2016
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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