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

NCT07798219 | Not Yet Recruiting

• 1 other identifier: STUDY00004148
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Obesity; Obesity-related HFpEF; Obesity and heart failure; Obesity treatment; Heart failure outcomes; Endoscopic sleeve gastroplasty (ESG)

Outcome Measures

Primary Outcomes (2)

• 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

  Score range: 0-100- Higher scores indicate better health status and lower heart failure symptom burden. Positive changes from baseline reflect improvement

  From baseline to the end of 12 month follow up.

• To assess percent body weight loss (TBWL) at 12 months post-ESG (%)

  Percent total body weight loss (TBWL) at 12 months following ESG, calculated as the percentage change in body weight from baseline.

  From baseline to the end of 12 months follow-up.

Study Arms (1)

Endoscopic sleeve gastroplasty (ESG)

EXPERIMENTAL

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.

Procedure: Endoscopic sleeve gastroplasty (ESG)

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.

Endoscopic sleeve gastroplasty (ESG)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI 30-50 kg/m2
• Stable weight within the 3-months prior to enrollment (\< 5 % weight loss or gain)
• Documented heart failure, defined by satisfying at least one of the below criteria, with left ventricular ejection fraction ≥ 45% at time of screening
• Elevated left ventricular filling pressures
• Elevate natriuretic peptide levels
• Echocardiographic abnormalities consistent with HFpEF
• Hospitalization for heart failure in prior 12 months plus ongoing treatment with diuretics
• NYHA Functional Class II-IV
• KCCQ-CSS score \< 90
• minute walk test \> 100 m
• No hospitalizations due to HF between screening and baseline visit
• Satisfies the indications for use and intended population as described in the IFU for Overstitch Endoscopic Suturing System
• Is not currently taking any over the counter or prescribed weight loss supplements or any anti-obesity medications
• Agrees not to take additional over the counter or prescribed weight loss supplements / medications during study participation
• Medications for management of diabetes that are stable for the last 6 months, no changes to type or dose and no expected changes during study participation

You may not qualify if:

• Patients not willing to have an ESG procedure for the treatment of weight loss
• History of prior bariatric surgery or procedure
• Pre-existing esophageal stenosis/stricture preventing advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD)
• Esophageal, gastric or duodenal malignancy
• Uncontrolled coagulopathy or inability to be off anticoagulation or anti-platelet medication (ASA, Plavix) for 1 week prior to and 2 weeks after each endoscopy
• Known portal hypertension, visible esophageal or gastric varices, or history of esophageal varices
• Prior surgical or endoscopic anti-reflux procedure
• Current or planned management of Type 2 Diabetes with incretin medications
• Inability or unwillingness to comply with protocol requirements related to visits
• Investigator's medical judgement that the subject is not a candidate for the ESG procedure
• MI, stroke, hospitalization for HF, unstable angina pectoris, or TIA within 30 days prior to the day of screening
• SBP \>160 mm Hg at screening
• Planned coronary, carotid or peripheral artery revascularization
• Any other condition judged by the investigator to be the primary cause of dyspnea
• End-stage renal disease or chronic or intermittent hemodialysis or peritoneal dialysis

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Obesity; Heart Failure

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 1, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)