Status:
RECRUITING
Mechanisms of Semaglutide Therapy in Heart Failure Patients
Lead Sponsor:
University Medical Centre Ljubljana
Collaborating Sponsors:
Stanford University
Greenstone Biosciences
Conditions:
Heart Failure
Obesity
Eligibility:
All Genders
20-80 years
Phase:
PHASE1
PHASE2
Brief Summary
Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, primarily used for treatment of type-2 diabetes mellitus. GLP-1 receptors are present on pancreatic islet β-cells, δ-cells and α-cell...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06541509
Start Date
July 10 2024
End Date
September 1 2025
Last Update
August 7 2024
Active Locations (3)
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1
Greenstone Biosciences
Palo Alto, California, United States, 94304
2
Stanford Cardiovascular Institute
Stanford, California, United States, 94305
3
University Medical Center Ljubljana
Ljubljana, Slovenia, 1000