Functional Impact of GLP-1 for Heart Failure Treatment (FIGHT)

What Was Tested

The trial (phase 2) is built around Liraglutide.

It had two arms (groups): Liraglutide (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Glucagon-like peptide-1 (GLP-1) is a naturally occurring incretin peptide that enhances cellular glucose uptake by stimulating insulin secretion and insulin sensitivity in target tissues.

Who Took Part

Enrollment: 300 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age ≥ 18 years. AHFS as defined by the presence of at least 1 symptom (dyspnea, orthopnea, or edema) AND 1 sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on chest radiography). AHFS is the primary cause of hospitalization. Prior clinical diagnosis of HF. On evidence-based medication for HF (including beta-blocker and ACE-inhibitor/ARB) or previously deemed intolerant.

The full record lists 8 inclusion and 38 exclusion criteria; among the exclusions: AHFS due to acute myocarditis or acute Myocardial Infarction; inotrope, intra-aortic balloon pump (iabp) or other mechanical circulatory support use at the time of consent. prior use will not exclude a patient; current or planned left ventricular assist device therapy in next 180 days.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2013-04 with completion listed for 2015-10.

It ran at 25 sites in United States (25).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Global Ranking of Predefined Events (time frame: Randomization to 180 days).

It also tracked 18 secondary outcomes, for example Change in Left Ventricular End-Diastolic Volume Index, Change in Left Ventricular End-systolic Volume Index, Change in Left Ventricular Ejection Fraction, Change in Medial Filling Pressure, Change in Lateral Filling Pressure and Change in 6 Minute Walk Distance.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 300 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Liraglutide compound page, all human trials.