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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 May 2023 |
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Main ID: |
NCT02923609 |
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Date of registration:
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03/10/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cell Therapy in HFpEF
CELLpEF |
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Scientific title:
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A PILOT TRIAL OF CELL THERAPY IN HEART FAILURE WITH PRESERVED EJECTION FRACTION |
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Date of first enrolment:
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January 2016 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02923609 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Slovenia
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Contacts
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Name:
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Bojan Vrtovec, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Cardiology, UMC Ljubljana |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Heart Failure With Normal Ejection Fraction
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Intervention(s)
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Biological: Cell Therapy
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Primary Outcome(s)
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Change in left ventricular filling pressures (E/e') assessed by echocardiography
[Time Frame: Baseline, 6 months and 1 year]
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Secondary Outcome(s)
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Change in diastolic dysfunction grade
[Time Frame: Baseline, 6 months and 1 year]
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Change in systolic strain
[Time Frame: Baseline, 6 months and 1 year]
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Change in exercise capacity
[Time Frame: Baseline, 6 months and 1 year]
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Change in NT-proBNP levels
[Time Frame: Baseline, 6 months and 1 year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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