N/A
Completed N=12
Pilot Feasibility Study of the Safety and Efficacy of Anakinra in Heart Failure With Preserved Ejection Fraction
Source: ClinicalTrials.gov NCT01542502 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcomePrimary: Peak Oxygen Consumption (Peak VO2) — 1.1; -0.1 ml*kg^-1*min^-1 — p=0.009
Summary
This will be a randomized, double-blind, crossover pilot study to measure the safety and feasibility of Interleukin-1 (IL-1) blockade with Anakinra in patients with stable heart failure with preserved ejection fraction.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Oxygen Consumption (Peak VO2) |
1.1; -0.1 | 0.009 sig |
| SECONDARY Exercise Time |
0.05; 0.4 | 0.87 |
Eligibility Criteria
Inclusion Criteria
- Symptoms and signs of congestive heart failure
- Recent Imaging Study ( 50% and Left Ventricular End Diastolic Volume Index (LVEDVI) 12
- Left Ventricular End Diastolic Pressure (LVEDP) >16 mmHg
- Tissue Doppler Echocardiogram
- E/E' >15
- E/E' 8-15 and one of the following
- Left Ventricular Hypertrophy (LVH)
- Atrial Fibrillation
- Left Atrial Enlargement
- E/A 280 (if >50yrs of age)
- Biomarkers
- Brain Natriuretic Peptide (BNP) >200pg/mL
Exclusion Criteria
- Age <18
- Recent changes (previous 3 months) in HF maintenance medications (beta-blockers, angiotensin converting enzyme [ACE] inhibitors, aldosterone antagonists, vasodilators, cardiac glycosides, diuretics)
- Hospitalization for worsening Heart Failure (HF) or acute decompensated HF within the previous 12months
- Anticipated need for cardiac resynchronization therapy (CRT) or automated-implantable cardioverter defibrillator (AICD)
- Angina or electrocardiograph (ECG) changes that limit maximum exertion during cardiopulmonary exercise testing
- Active infection including chronic infection
- Active cancer
- Recent (<14 days) use of anti-inflammatory drugs (not including Non-Steroidal Anti-Inflammatory Drugs [NSAIDs]), Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus), malignancy, or any comorbidity limiting survival or ability to complete the study
- Pregnancy (determined by urine pregnancy test in women of childbearing potential)
- Inability to give informed consent
- Other conditions limiting completion of cardiopulmonary exercise test or completion of the study
Data sourced from ClinicalTrials.gov (NCT01542502). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.