Obesity (BMI>30)NCT07798219
Pilot Study of Endoscopic Sleeve Gastroplasty for Obese Patients With Heart Failure and Preserved Ejection Fraction
A study testing Endoscopic sleeve gastroplasty (ESG) in people with Obesity (BMI>30) and Heart Failure With Preserved Ejection Fraction (HFPEF), run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Obesity (BMI>30), Heart Failure With Preserved Ejection Fraction (HFPEF)
- What is being tested?
- Endoscopic sleeve gastroplasty (ESG)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Hospitalization for heart failure in prior 12 months plus ongoing treatment with diuretics
- NYHA Functional Class II-IV
- KCCQ-CSS score < 90
- 6-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
- Agrees to the follow-up requirements of the study and provides informed consent
Who cannot join
- 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
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- 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
- Presence or history of malignant neoplasm within 5 years prior to the day of screening Basal and squamous cell cancer and any carcinoma in-situ are allowed
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
- Participation in any clinical trial of an approved or non-approved device for the treatment of HF or obesity within 30 days before screening
- Major surgery scheduled for the duration of the trial, affecting walking ability in the opinion of the investigator
- Any disorder, including severe psychiatric disorder, suicidal behavior within 90 days before screening, and suspected drug abuse, which in the investigator´s opinion might jeopardize subject´s safety or compliance with the protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Pilot Clinical Study Evaluating Endoscopic Sleeve Gastroplasty (ESG) for Obese Patients With Heart Failure With Preserved Ejection Fraction
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.
Read the detailed description
During the ESG procedure, a specially trained doctor uses a flexible tube passed through the mouth to place stitches inside the stomach. This makes the stomach smaller so people feel full sooner and eat less, which can help with weight loss. The procedure uses the OverStitch Endoscopic Suturing System and is performed by trained gastroenterologists or surgeons.
The study is for adults with obesity who have a BMI between 30 and 50 and have not been able to lose weight or keep it off through diet, exercise, or other non-surgical approaches.
The goal of the study is to learn whether weight loss after ESG can improve heart failure symptoms, such as shortness of breath, tiredness, and difficulty with physical activity.
- Being tested
- Endoscopic sleeve gastroplasty (ESG)
- Keywords
- Obesity, Obesity-related HFpEF, Obesity and heart failure, Obesity treatment, Heart failure outcomes, Endoscopic sleeve gastroplasty (ESG)
- Medical subject headings
- Obesity, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic sleeve gastroplasty (ESG)Procedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Endoscopic sleeve gastroplasty (ESG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: From baseline to the end of 12 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (BMI>30)Studies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Farkouh, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798219
- Sponsor's protocol ID
- STUDY00004148
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will not be shared because of participant privacy considerations and limitations of the informed consent.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Study Evaluating Endoscopic Sleeve Gastroplasty (ESG) for Obese Patients With Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT07798219
- Acronym / sponsor ID
- STUDY00004148
- Keywords
- Obesity, Obesity-related HFpEF, Obesity and heart failure, Obesity treatment, Heart failure outcomes, Endoscopic sleeve gastroplasty (ESG)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
During the ESG procedure, a specially trained doctor uses a flexible tube passed through the mouth to place stitches inside the stomach. This makes the stomach smaller so people feel full sooner and eat less, which can help with weight loss. The procedure uses the OverStitch Endoscopic Suturing System and is performed by trained gastroenterologists or surgeons.
The study is for adults with obesity who have a BMI between 30 and 50 and have not been able to lose weight or keep it off through diet, exercise, or other non-surgical approaches.
The goal of the study is to learn whether weight loss after ESG can improve heart failure symptoms, such as shortness of breath, tiredness, and difficulty with physical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic sleeve gastroplasty (ESG) | Experimental | Procedure: 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic sleeve gastroplasty (ESG)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. | Procedure or surgery | Endoscopic sleeve gastroplasty (ESG) |
Primary outcome
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.
Score range: 0-100- Higher scores indicate better health status and lower heart failure symptom burden. Positive changes from baseline reflect improvement
To assess percent body weight loss (TBWL) at 12 months post-ESG (%)
Time frame: From baseline to the end of 12 months follow-up.
Percent total body weight loss (TBWL) at 12 months following ESG, calculated as the percentage change in body weight from baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No. The IPD will not be shared because of participant privacy considerations and limitations of the informed consent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic sleeve gastroplasty (ESG) in people with Obesity (BMI>30) and Heart Failure With Preserved Ejection Fraction (HFPEF), run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.