Pilot Feasibility Study of the Safety and Efficacy of Anakinra in Heart Failure With Preserved Ejection Fraction
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|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||Phase|
|Heart Failure||Drug: Anakinra Drug: Placebo||Not Applicable|
|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|
|Actual Primary Completion Date :||June 2013|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|