Mechanisms of Semaglutide Therapy in Heart Failure Patients

Last updated: August 5, 2024
Sponsor: University Medical Centre Ljubljana
Overall Status: Active - Recruiting

Phase

1/2

Condition

Obesity

Diabetes Prevention

Hyponatremia

Treatment

Semaglutide

Clinical Study ID

NCT06541509
SEMAHEART
  • Ages 20-80
  • All Genders

Study 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-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. In large clinical trials, semaglutide improved the outcomes in obese patients, patients with heart failure with preserved ejection fraction, and decreased the heart failure hospitalizations in patients with type 2 diabetes. The aim of the present study is to investigate the underlying mechanisms of the beneficial clinical effects of semaglutide in the setting of chronic heart failure.

Eligibility Criteria

Inclusion

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

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 > 3times upper limits of normal or total bilirubin greater than 1.5 times upper limitsof 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 IVsymptoms.

  • Prior or planned bariatric surgery

  • Self-reported change in body weight >11 lbs (5 kg) within 3 months before enrollment

  • Acute or chronic infection

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Semaglutide
Phase: 1/2
Study Start date:
July 10, 2024
Estimated Completion Date:
September 01, 2025

Connect with a study center

  • University Medical Center Ljubljana

    Ljubljana, 1000
    Slovenia

    Active - Recruiting

  • Greenstone Biosciences

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • Stanford Cardiovascular Institute

    Stanford, California 94305
    United States

    Active - Recruiting

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