Mechanisms of Semaglutide Therapy in Heart Failure Patients
NCT ID: NCT06541509
Last Updated: 2024-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
10 participants
INTERVENTIONAL
2024-07-10
2025-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Semaglutide Therapy
Timepoints:
* Baseline (Week 0)
* Week 2 (Visit 1)
* Week 4 (Visit 2)
* Week 12 (Visit 3)
* Week 16 (Visit 4)
Medication Schedule:
Subcutaneous semaglutide (Ozempyc, Novo Nordisk A/S Bagsvaerd, Denmark) First 2 weeks: Semaglutide; 0.25 mg weekly Second 2 weeks: Semaglutide; 0.5 mg weekly Remaining 12 weeks: Semaglutide; 1 mg weekly
Semaglutide
10 overweight patients with heart failure will be enrolled, including 5 patients with heart failure with preserved ejection fraction (HFpEF) and 5 patients with heart failure with reduced ejection fraction (HFrEF). The diagnosis of HFpEF and HFrEF will be based on the most recent European Society of Cardiology guidelines for the diagnosis and treatment of heart failure.
After their baseline blood sample collections, all participants will receive once-weekly subcutaneous semaglutide (Ozempyc, Novo Nordisk A/S Bagsvaerd, Denmark) at a dose of 0.25 mg for 2 weeks, 0.5 mg for 2 weeks, and then 1.0 mg for a period of 12 weeks. At the end of the 3-month and 4-month period, blood sample collections will be repeated. All blood samples will be sent to Stanford Cardiovascular Institute for further analyses. At baseline, and again at 4 months transthoracic echocardiography, 6-minute walk test, and body composition assessment will be performed.
Interventions
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Semaglutide
10 overweight patients with heart failure will be enrolled, including 5 patients with heart failure with preserved ejection fraction (HFpEF) and 5 patients with heart failure with reduced ejection fraction (HFrEF). The diagnosis of HFpEF and HFrEF will be based on the most recent European Society of Cardiology guidelines for the diagnosis and treatment of heart failure.
After their baseline blood sample collections, all participants will receive once-weekly subcutaneous semaglutide (Ozempyc, Novo Nordisk A/S Bagsvaerd, Denmark) at a dose of 0.25 mg for 2 weeks, 0.5 mg for 2 weeks, and then 1.0 mg for a period of 12 weeks. At the end of the 3-month and 4-month period, blood sample collections will be repeated. All blood samples will be sent to Stanford Cardiovascular Institute for further analyses. At baseline, and again at 4 months transthoracic echocardiography, 6-minute walk test, and body composition assessment will be performed.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
80 Years
ALL
No
Sponsors
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Stanford University
OTHER
Greenstone Biosciences
UNKNOWN
University Medical Centre Ljubljana
OTHER
Responsible Party
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Locations
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Greenstone Biosciences
Palo Alto, California, United States
Stanford Cardiovascular Institute
Stanford, California, United States
University Medical Center Ljubljana
Ljubljana, , Slovenia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SEMAHEART
Identifier Type: -
Identifier Source: org_study_id
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