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NCT02923609·Phase 2·INTERVENTIONAL

Cell Therapy in HFpEF

NesiritideOtherCompleted

Status

Completed

Phase

Phase 2

Enrollment

30

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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.

Full detailed description

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.

Interventions

Treatment arms and agents.

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.

Timeline

From registration to results.

  1. First posted

    Oct 4, 2016

  2. Study start

    Jan 2016

  3. Primary completion

    Jan 2022

  4. Study completion

    Mar 2022

  5. Results posted

    Not reported

  6. Registry updated

    May 10, 2023

Outcomes

What the study measures.

Primary outcomes

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

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.

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).

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.

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
70 Years
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

Slovenia. Showing up to 24 locations stored in the fast local snapshot.

University Medical Center Ljubljana

Ljubljana, Slovenia

Publications

Results and literature.

PMID 35775390 ↗Vrtovec B, Frljak S, Poglajen G, Zemljic G, Cerar A, Sever M, Haddad F, Wu JC. A pilot clinical trial of cell therapy in heart failure with preserved ejection fraction. Eur J Heart Fail. 2022 Aug;24(8):1441-1449. doi: 10.1002/ejhf.2596. Epub 2022 Jul 20.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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