Pilot Feasibility Study of the Safety and Efficacy of Anakinra in Heart Failure With Preserved Ejection Fraction
|ClinicalTrials.gov Identifier: NCT01542502|
Recruitment Status : Completed
First Posted : March 2, 2012
Results First Posted : April 7, 2016
Last Update Posted : February 6, 2017
|Condition or disease||Intervention/treatment|
|Heart Failure||Drug: Anakinra Drug: Placebo|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Pilot Feasibility Study of the Safety and Efficacy of Anakinra in Heart Failure With Preserved Ejection Fraction|
|Study Start Date :||February 2012|
|Primary Completion Date :||June 2013|
|Study Completion Date :||June 2013|
Treatment with daily subcutaneous injections of Anakinra 100 mg
Anakinra 100 mg daily subcutaneous injection
Placebo Comparator: Placebo
Treatment with daily subcutaneous injection of placebo
Placebo daily subcutaneous injection
Other Name: Sodium Chloride (NaCl) 0.9%
- Peak Oxygen Consumption (Peak VO2) [ Time Frame: 14 days ]The primary endpoint is the change in peak oxygen consumption among stable heart failure patients (n = 12) following 14-days treatment with daily doses of Anakinra 100 mg (SC, subcutaneous).
- Exercise Time [ Time Frame: 14 days ]Interval change from baseline in duration of exercise during a standardized cardiopulmonary exercise test upon completion of 2 weeks treatment
- Correlation Between Endpoints [ Time Frame: 28 days ]Correlation between interval change in peak VO2 and high sensitivity C-reactive protein
- Heart Failure Symptoms (DASI) [ Time Frame: 28 days ]Interval change from baseline in Heart Failure (HF) symptoms as measured by Duke Activity Status Index (DASI) upon completion of 2 weeks treatment.
- Adverse Events [ Time Frame: 28 days ]Additional endpoints will include assessment of adverse events and hospitalizations during 4-week duration of study.
- Inflammatory Biomarkers [ Time Frame: 28 days ]Interval change from baseline in high-sensitivity C-reactive protein upon completion of 2 weeks treatment.
- Ventilatory Efficiency (VE/VCO2 [Carbon Dioxide] Slope) [ Time Frame: 14 days ]Interval change from baseline in ventilatory efficiency (VE/VCO2 slope) upon completion of 2 weeks treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542502
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Antonio Abbate, MD, PhD||Virginia Commonwealth University|