NCT06541509 · University Medical Centre Ljubljana
Mechanisms of Semaglutide Therapy in Heart Failure Patients
(SEMAHEART)
What this study is about
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-cells. Their stimulation increases insulin and somatostatin secretion, and decreases glucagon secretion.
View original scientific description
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-cells. Their stimulation increases insulin and somatostatin secretion, and decreases glucagon secretion. In addition, GLP-1 receptor agonists appear to have multiple extrapancreatic actions, which remain poorly defined.
Interventions
DRUG
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.
Primary outcome measures
Interleukin-6 (IL-6)
Time frame: 4 months
Measured using enzyme linked immunosorbent assay (ELISA). Units of Measure: picograms per milliliter (pg/mL).
Interleukin-8 (IL-8)
Time frame: 4 months
Measured using ELISA. Units of Measure: picograms per milliliter (pg/mL).
Tumor Necrosis Factor-alpha (TNF-α)
Time frame: 4 months
Measured using ELISA. Units of Measure: picograms per milliliter (pg/mL).
Interferon-gamma (IFN-γ)
Time frame: 4 months
Measured using ELISA. Units of Measure: picograms per milliliter (pg/mL).
B-type Natriuretic Peptide (BNP)
Time frame: 4 months
Measured using immunoassay. Units of Measure: picograms per milliliter (pg/mL).
C-reactive Protein (CRP)
Time frame: 4 months
Measured using immunoassay. Units of Measure: picograms per milliliter (pg/mL).
Hemoglobin A1C (HgA1C)
Time frame: 4 months
Measured using standard laboratory methods. Units of Measure: percent (%).
Complete Blood Count (CBC)
Time frame: 4 months
Measured using automated hematology analyzer. CBC parameters will be measured in their respective units (e.g., cells per microliter).
Comprehensive Metabolic Panel (Chem 7)
Time frame: 4 months
Measured using standard laboratory methods. Chem 7 parameters will be measured in their respective units (e.g., mg/dL, U/L).
Liver Function Tests (LFT)
Time frame: 4 months
Measured using standard laboratory methods. LFT parameters will be measured in their respective units (e.g., mg/dL, U/L).
Body mass index
Time frame: 4 months
Patient weight will be measured in kilograms and height will be measured in meters. Body mass index (BMI) will be calculated according to the standard formula: weight in kilograms divided by height in meters squared.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Palo Alto, California
- Stanford, California
Collaborators
Stanford University, Greenstone Biosciences
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 7, 2024 · Source of record for eligibility and locations