Pilot Feasibility Study of the Safety and Efficacy of Anakinra in Heart Failure With Preserved Ejection Fraction
Information source: Virginia Commonwealth University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Failure
Intervention: Anakinra (Drug); Placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: Virginia Commonwealth University Official(s) and/or principal investigator(s): Antonio Abbate, MD, PhD, Principal Investigator, Affiliation: Virginia Commonwealth University
Summary
This will be a randomized, double-blind, crossover pilot study to measure the safety and
feasibility of IL-1 blockade with Anakinra in patients with stable heart failure with
preserved ejection fraction.
Clinical Details
Official title: Pilot Feasibility Study of the Safety and Efficacy of Anakinra in Heart Failure With Preserved Ejection Fraction
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Peak oxygen consumption (peak VO2)
Secondary outcome: Aerobic exercise parameters (VCO2, VE/VCO2 slope, exercise time)Inflammatory biomarkers Heart failure symptoms (DASI) Adverse events Correlation between endpoints
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Symptoms and signs of congestive heart failure
- Recent Imaging Study (<12 months) showing LVEF>50% and LVEDVI<97ml/m2
- Evidence of abnormal LV relaxation, filling, diastolic distensibility, and diastolic
stiffness as shown by one of the following:
1. Invasive Hemodynamic measurements
- mPCW >12
- LVEDP>16mmHg
2. Tissue Doppler Echocardiogram
- E/E' >15
- E/E' 8-15 and one of the following
- LVH
- Afib
- LAE
- E/A<0. 5+DT>280(if >50yrs of age)
3. Biomarkers
- 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 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 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
Locations and Contacts
Virginia Commonwealth University, Richmond, Virginia 23298, United States
Additional Information
Starting date: February 2012
Last updated: August 30, 2013
|