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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

Page last updated: August 23, 2015

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