NCT02911337

Weight Loss as Therapy for Heart Failure With Preserved Ejection Fraction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the efficacy of an intensive, supervised, lifestyle modification program on symptoms and signs of heart failure as well as laboratory and echocardiographic measures of cardiac structure and function. This will be a 6 month trial in 50 patients with a clinical diagnosis of heart failure with preserved ejection fraction (HFpEF). Patients will be enrolled in the Medical University of South Carolina weight management 15 week lifestyle change program which will involve weekly visits that rotate among the clinical specialities (dietary, exercise and behavioral) and scheduled visits with the research Registered Nurse. Each patients baseline data will be used as the control and compared with the same measurements at the 6 month end point.

Conditions

• Heart Failure, Diastolic
• Weight Loss

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	lifestyle modification	Subjects will be given meal replacements (shakes and bars) to be consumed twice per day for 8 weeks, and then once per day for an additional 3 weeks, and then transitioned to a structured diet.

Timeline

• Start date: 2015-08-01
• Primary completion: 2018-12-28
• Completion: 2018-12-28
• First posted: 2016-09-22
• Last updated: 2025-07-10

Locations

1 site across 1 country: United States