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Glucagon-like peptide-1 receptor agonist

Semaglutide + Lifestyle Counseling for Heart Failure

Phase 2

Recruiting

Led By Barry Borlaug, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

NYHA Class II-IV

NT-proBNP levels and echocardiography criteria based on BMI at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 months

Awards & highlights

Study Summary

This trial will test if weight loss can help improve heart function in obese people with heart failure.

Who is the study for?

This trial is for adults with obesity-related heart issues (HFpEF) who have a BMI of 30 or higher, experience certain types of heart failure symptoms, and haven't been hospitalized for heart failure in the last month. People can't join if they've had bariatric surgery, used GLP-1 receptor agonists recently, have specific health risks like pancreatitis or severe psychiatric disorders, are pregnant or not using effective contraception, plan major surgery that affects walking ability during the trial period.Check my eligibility

What is being tested?

The study tests whether an aggressive weight loss intervention combined with Semaglutide improves symptoms in patients with HFpEF compared to a placebo group. Participants will also receive counseling on healthy lifestyle changes as part of the treatment process.See study design

What are the potential side effects?

Semaglutide may cause side effects such as digestive problems (nausea and vomiting), potential inflammation of organs like the pancreas (pancreatitis), allergic reactions if sensitive to ingredients, and possibly affect blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have moderate to severe heart condition symptoms.

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My heart function tests are within the required range for my body size.

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I was hospitalized for worsening heart failure in the last year and had an echocardiogram.

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I have not been hospitalized for heart failure in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pulmonary Capillary Wedge Pressure (PCWP)

Secondary outcome measures

Body fat mass

Change in Quality of Life (QOL) as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)

Left Atrial (LA) reservoir strain

+14 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Semaglutide TreatmentActive Control2 Interventions

Subjects will receive Semaglutide once weekly in addition to counselling on healthy lifestyle intervention

Group II: Placebo TreatmentPlacebo Group2 Interventions

Subjects will receive matching placebo once weekly in addition to counselling on healthy lifestyle intervention

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,212 Previous Clinical Trials

3,766,957 Total Patients Enrolled

72 Trials studying Heart Failure

1,021,947 Patients Enrolled for Heart Failure

United States Department of DefenseFED

865 Previous Clinical Trials

327,618 Total Patients Enrolled

1 Trials studying Heart Failure

90 Patients Enrolled for Heart Failure

Barry Borlaug, MDPrincipal InvestigatorMayo Clinic

9 Previous Clinical Trials

1,378 Total Patients Enrolled

6 Trials studying Heart Failure

998 Patients Enrolled for Heart Failure

Media Library

Semaglutide (Glucagon-like peptide-1 receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05371496 — Phase 2

Heart Failure Research Study Groups: Semaglutide Treatment, Placebo Treatment

Heart Failure Clinical Trial 2023: Semaglutide Highlights & Side Effects. Trial Name: NCT05371496 — Phase 2

Semaglutide (Glucagon-like peptide-1 receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05371496 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still capacity for enrolment in this medical experiment?

"Confirmed, this clinical trial is accepting participants as reported on the website. The initial post was made on September 6th 2022 with a recent edit to the listing being conducted that same day."

Answered by AI

Has Semaglutide Treatment been verified by the FDA?

"Semaglutide Treatment was assigned a score of 2 according to our team at Power, as the drug has yet to have its efficacy confirmed but there are some clinical studies showing it is safe."

Answered by AI

What is the maximum participant capacity for this research project?

"Affirmative. According to information hosted on clinicaltrials.gov, the trial is presently recruiting for 81 participants from one location and was initially posted in September 6th 2022 with a most recent update dated same day."

Answered by AI