NCT01800968

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

Functional Impact of GLP-1 for Heart Failure Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Heart Failure

Interventions

Type	Name	Description
DRUG	Liraglutide	Active Drug
DRUG	Placebo	Placebo

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2013-02-28
• Last updated: 2017-02-15
• Results posted: 2017-02-15

Locations

25 sites across 1 country: United States