RECRUITING

Mechanisms of Semaglutide Therapy in Heart Failure Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. 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.

Official Title

A Pilot Clinical Trial Investigating Underlying Mechanisms of Semaglutide Therapy in Heart Failure Patients

Quick Facts

Study Start:2024-07-10
Study Completion:2025-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06541509

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:20 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age: 20-80 years
  2. * Presence of heart failure
  3. * Body-mass index 27 kg/m2 or greater
  4. * Stable optimally tolerated dosages of heart failure therapies for 3 months
  5. * N-terminal pro B-type natriuretic peptide levels \>350 pg/mL
  1. * Presence of type 1 or type 2 diabetes or glycated haemoglobin higher than 6.5%
  2. * Pregnancy or potential to become pregnant
  3. * Cancer
  4. * 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)
  5. * Renal dysfunction (estimated glomerular filtration rate less than 25 mL/min/1.73 m2)
  6. * Hospitalization in the past 3 months for reasons other than heart failure
  7. * New York Heart Association (NYHA) functional class I or functional class IV symptoms.
  8. * Prior or planned bariatric surgery
  9. * Self-reported change in body weight \>11 lbs (5 kg) within 3 months before enrollment
  10. * Acute or chronic infection

Contacts and Locations

Study Contact

Bojan Vrtovec, MD, PhD
CONTACT
+3861 522 1157
bojan.vrtovec@kclj.si
Sabina Frljak, MD, PhD
CONTACT
+3861 522 2844
sabina.frljak@kclj.si

Study Locations (Sites)

Greenstone Biosciences
Palo Alto, California, 94304
United States
Stanford Cardiovascular Institute
Stanford, California, 94305
United States

Collaborators and Investigators

Sponsor: University Medical Centre Ljubljana

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-10
Study Completion Date2025-09-01

Study Record Updates

Study Start Date2024-07-10
Study Completion Date2025-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Heart Failure
  • Obesity