NIH grant: Targeted Interleukin-1 Blockade in Acute Systolic Heart Failure (1R61HL178692-01A1)

retained text

NIH grant 1R61HL178692-01A1: Targeted Interleukin-1 Blockade in Acute Systolic Heart Failure
Institute: {'code': 'HL', 'abbreviation': 'NHLBI', 'name': 'National Heart Lung and Blood Institute', 'admin_org_id': '12500068', 'admin_funding_url': ''}. PI: Antonio  Abbate. Award: $752390.
Start: 2026-08-15T00:00:00.
Project Summary
This application is for a Single-Site Investigator-Initiated Clinical Trial (R61/R33) entitled “Targeted Interleukin-1
Blockade in Acute 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 among the leading causes of admission in the US. Up to 1 in 3 patients hospitalized with acute HF will be
readmitted within 90 days and up to 1 in 8 patients will die within 90 days after discharge There is an urgent
need to develop novel treatments to alleviate symptoms during acute HF hospitalization. An acute inflammatory
response accompanies the symptoms of acute HF. The intensity of this inflammatory responses predicts the
severity of disease and identifies patients at risk for poor outcomes. Among the inflammatory pathways identified,
Interleukin-1 (IL-1) is a key mediator of systemic inflammation that becomes elevated in HF patients and may
have a mechanistic link to perpetuation of the inflammatory response and specific HF pathologies such as
difficulty breathing, fluid retention, cardiac dysfunction, kidney dysfunction, and impaired cardiorespiratory
fitness. Prior studies of IL-1 blockade in patients at risk for HF or with stable HF suggest that prolonged IL-1
blockade may improve cardiorespiratory fitness and reduce HF hospitalization. However, no studies have
established the benefits of IL-1 blockade during the critical first days of a hospitalization for acute heart failure.
This proposal will support a randomized, double-blind, phase II clinical trial (n=80) to validate the anti-
inflammatory effect of IL-1 blockade with goflikicept, a novel IL-1 trap and to determine the benefits of IL-1
blockade on dyspnea, fluid retention, cardiac and kidney function and cardiorespiratory fitness. Eligible patients
will be randomized to a single dose of goflikicept 160 mg (n=40) or placebo (n=40) on the day of admission.
Results from this study will be used to optimize the treatment strategy and design a subsequent phase III clinical
trial to evaluate morbidity and mortality with IL-1 blockade in patients hospitalized with acute systolic HF.

document fetched 2026-08-23 06:34