# The Effects of Interleukin-1 Blockade On Exercise Capacity In Patients With Recently Decompensated Systolic Heart Failure

> **NIH NIH R33** · VIRGINIA COMMONWEALTH UNIVERSITY · 2020 · $547,121

## Abstract

Project Summary
 This application is for a Single-Site Investigator-Initiated Clinical Trial (R61/R33) entitled “Effects of
Interleukin-1 blockade on exercise capacity in patients with recently decompensated systolic heart failure”
submitted by Antonio Abbate MD, PhD and Benjamin Van Tassell, PharmD. Heart failure (HF) is a complex
clinical syndrome characterized by fatigue and labored breathing upon exertion. Although current treatment
options have extended life expectancy, prognosis for HF remains poor and HF is the leading cause of
admission among elderly patients in the US. There is an urgent need to develop novel treatments to alleviate
symptoms, slow disease progression, and reduce HF hospitalization.
 A significant correlation exists between declining cardiac function and increasing levels of inflammatory
cytokines in HF patients. Among these cytokines, Interleukin-1 (IL-1) is a key mediator of systemic
inflammation that becomes elevated in HF patients and may contribute to poor cardiac function. In animal
models of HF, IL-1 is sufficient to cause significant depression of cardiac function, impaired cardiac reserve,
and worsened cardiac remodeling. In a recent pilot study, 12 weeks treatment with recombinant human IL-1
receptor antagonist (IL-1Ra, anakinra) produced a significant improvement in aerobic exercise performance as
measured by peak oxygen consumption (VO2).
 This proposal will support a randomized, double-blind, phase II clinical trial (n=102) to confirm the effect
of IL-1 blockade to improve exercise capacity in HF patients and estimate the potential benefit of IL-1 blockade
on HF readmission in patients with recently decompensated heart failure (HF). Eligible patients will be
randomized to 24 weeks treatment with anakinra (n=68) or placebo (n=34). Results from this study will be used
to optimize the treatment strategy and design a subsequent phase III clinical trial to evaluate long-term
morbidity and mortality with IL-1 blockade in HF patients.

## Key facts

- **NIH application ID:** 9954145
- **Project number:** 5R33HL139943-03
- **Recipient organization:** VIRGINIA COMMONWEALTH UNIVERSITY
- **Principal Investigator:** Antonio Abbate
- **Activity code:** R33 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $547,121
- **Award type:** 5
- **Project period:** 2018-07-01 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9954145

## Citation

> US National Institutes of Health, RePORTER application 9954145, The Effects of Interleukin-1 Blockade On Exercise Capacity In Patients With Recently Decompensated Systolic Heart Failure (5R33HL139943-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9954145. Licensed CC0.

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