Cell Therapy in HFpEF

University Medical Centre Ljubljana30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure With Normal Ejection Fraction

Interventions

Cell TherapyBIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

University Medical Center Ljubljana

Ljubljana, Slovenia

Outcomes

Primary Outcomes

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

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.