Functional Impact of GLP-1 for Heart Failure Treatment (FIGHT)
The primary objective is to test the hypothesis that, compared with placebo, therapy with Subcutaneous (SQ) GLP-1 agonist in the post-Acute Heart Failure Syndrome (AHFS) discharge period will be associated with greater clinical stability at six months as assessed by a composite clinical endpoint.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Functional Impact of GLP-1 for Heart Failure Treatment|
- Global Ranking of predefined events [ Time Frame: Randomization to 180 days ] [ Designated as safety issue: Yes ]
All patients participating(regardless of treatment assignment) will be ranked on the basis of a prespecified hierarchical ranking of the following:
- Time to death
- Time to HF hospitalization
- Time-averaged proportional change in Pro-B-type Natriuretic peptide (NT-proBNP) (baseline to 180 days)
- Change in Cardiac Structure and function [ Time Frame: Baseline to 180 days ] [ Designated as safety issue: No ]Change in cardiac structure and function (by echocardiography) from baseline to 180 days.
- Individual Component of the primary endpoint- Time to death [ Time Frame: Randomization to 30, 90 and 180 days ] [ Designated as safety issue: No ]Individual component of the primary endpoint of Death at 30, 90 and 180 days after randomization
- Number of combined events- Death, HF hospitalization and ED visits [ Time Frame: Randomization to day 210 ] [ Designated as safety issue: Yes ]
Number of combined events:
- Death and HF hospitalization or
- Death + HF hospitalization + Emergency Department (ED) visits
- Change in symptoms using the Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Baseline to day 180 ] [ Designated as safety issue: No ]Change in KQQC symptoms.
- Functional Status (6MWT) [ Time Frame: Baseline, 30, 90 and 180 days ] [ Designated as safety issue: No ]Functional status change at 30, 90 and 180 days.
- Individual component of the primary endpoint- time to HF hospitalization [ Time Frame: Randomization to 30, 60 and 180 days ] [ Designated as safety issue: No ]Individual component of the primary endpoint- time to HF hospitalization from randomization to 30, 60 and 90 days
- Individual component of the primary endpoint- time-averaged proportional change in NT-proBNP [ Time Frame: Baseline to 180 days ] [ Designated as safety issue: No ]Individual component of the primary endpoint- time-averaged proportional change in NT-proBNP from baseline to 180 days
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Liraglutide
Increasing dose from 0.6mg, 1.2mg to 1.8mg SQ daily.
Other Name: Victoza
Placebo Comparator: Placebo
Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg SQ daily.
Other Name: Placebo
Hospitalization for AHFS identifies individuals at increased risk of death and re-hospitalization following discharge. This increased risk justifies intervention with novel therapy during the vulnerable post-discharge period to enhance clinical stability and prevent early HF mortality and readmissions.
As heart failure (HF) progresses, impairments in metabolism render the heart substrate constrained, limiting cardiac metabolism. 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. Preclinical and early-phase clinical data support GLP-1 as an effective therapy for advanced HF while use of GLP-1 receptor agonists in large numbers of patients with diabetes reveal a good safety profile and reductions in adverse cardiac outcomes.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01800968
|Contact: Gayle E Paynter, MBA, PMPfirstname.lastname@example.org|
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|Principal Investigator:||Adrian Hernandez, MD||Duke University|
|Study Chair:||Eugene Bruanwald, MD||Harvard University|