Pilot Study of Endoscopic Sleeve Gastroplasty for Obese Patients With Heart Failure and Preserved Ejection Fraction

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT07798219
Status
Not Yet Recruiting

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Conditions

  • Heart Failure With Preserved Ejection Fraction (HFPEF)
  • Obesity (BMI>30)

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Endoscopic sleeve gastroplasty (ESG) — PROCEDURE
    The endoscopic sleeve gastroplasty (ESG) is a minimally invasive, non-surgical weight-loss procedure. During the procedure, a flexible endoscope is passed through the mouth into the stomach. Using the OverStitch Endoscopic Suturing System, the physician places a series of sutures to reduce the stomach's volume.

Study Details

This is a small research study to see whether losing weight with a minimally invasive weight-loss procedure called endoscopic sleeve gastroplasty (ESG) can help improve symptoms of a type of heart failure called HFpEF in adults with obesity.

Key Dates

First listed
Sep 1, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Endoscopic sleeve gastroplasty (ESG)
    All participants will undergo endoscopic sleeve gastroplasty (ESG), a minimally invasive, non-surgical weight-loss procedure. During the procedure, a flexible endoscope is passed through the mouth into the stomach. Using the OverStitch Endoscopic Suturing System, the physician places a series of sutures to reduce the stomach's volume. The reduced stomach size promotes earlier fullness during meals, helping participants decrease food intake and achieve weight loss.

Primary Outcome Measure

To assess improvement in HFpEF symptom burden at 12 months post-ESG, as measured by change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) from baseline [ Time Frame: From baseline to the end of 12 month follow up. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-

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By research site
Cedars-Sinai Medical Center· Los Angeles, CA

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