Investigating how semaglutide helps heart failure patients
A Pilot Clinical Trial Investigating Underlying Mechanisms of Semaglutide Therapy in Heart Failure Patients
PHASE1; PHASE2 · University Medical Centre Ljubljana · NCT06541509
This study is testing if the medication semaglutide can help people with heart failure and obesity feel better and reduce hospital visits.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | University Medical Centre Ljubljana (other) |
| Locations | 3 sites (Palo Alto, California and 2 other locations) |
| Trial ID | NCT06541509 on ClinicalTrials.gov |
What this trial studies
This study explores the mechanisms by which semaglutide, a GLP-1 receptor agonist, may improve outcomes in patients with heart failure and obesity. It aims to understand the drug's effects on insulin and glucagon secretion, as well as its extrapancreatic actions that could benefit heart failure patients. Participants will be monitored while receiving semaglutide to assess its impact on heart failure symptoms and hospitalizations. The study includes patients aged 20-80 with specific heart failure criteria and excludes those with diabetes or significant liver or renal dysfunction.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20-80 with heart failure and a body mass index of 27 kg/m2 or greater.
Not a fit: Patients with type 1 or type 2 diabetes, significant liver or renal dysfunction, or recent weight changes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for heart failure patients, particularly those who are also obese.
How similar studies have performed: Previous studies have shown that GLP-1 receptor agonists like semaglutide can improve outcomes in heart failure patients, suggesting a promising avenue for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 20-80 years * Presence of heart failure * Body-mass index 27 kg/m2 or greater * Stable optimally tolerated dosages of heart failure therapies for 3 months * N-terminal pro B-type natriuretic peptide levels \>350 pg/mL Exclusion Criteria: * Presence of type 1 or type 2 diabetes or glycated haemoglobin higher than 6.5% * Pregnancy or potential to become pregnant * Cancer * Liver dysfunction (aspartate aminotransferase and/or alanine aminotransferase \> 3 times upper limits of normal or total bilirubin greater than 1.5 times upper limits of normal) * Renal dysfunction (estimated glomerular filtration rate less than 25 mL/min/1.73 m2) * Hospitalization in the past 3 months for reasons other than heart failure * New York Heart Association (NYHA) functional class I or functional class IV symptoms. * Prior or planned bariatric surgery * Self-reported change in body weight \>11 lbs (5 kg) within 3 months before enrollment * Acute or chronic infection
Where this trial is running
Palo Alto, California and 2 other locations
- Greenstone Biosciences — Palo Alto, California, United States (RECRUITING)
- Stanford Cardiovascular Institute — Stanford, California, United States (RECRUITING)
- University Medical Center Ljubljana — Ljubljana, Slovenia (RECRUITING)
Study contacts
- Study coordinator: Bojan Vrtovec, MD, PhD
- Email: bojan.vrtovec@kclj.si
- Phone: +3861 522 1157
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure, Obesity