Actively Recruiting

Phase 1
Phase 2
Age: 20Years - 80Years
All Genders
NCT06541509

Mechanisms of Semaglutide Therapy in Heart Failure Patients

Led by University Medical Centre Ljubljana · Updated on 2024-08-07

10

Participants Needed

3

Research Sites

59 weeks

Total Duration

On this page

Sponsors

U

University Medical Centre Ljubljana

Lead Sponsor

S

Stanford University

Collaborating Sponsor

AI-Summary

What this Trial 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. 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.

CONDITIONS

Official Title

Mechanisms of Semaglutide Therapy in Heart Failure Patients

Who Can Participate

Age: 20Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 20 and 80 years
  • Diagnosis of heart failure
  • Body mass index of 27 kg/m2 or greater
  • Stable and optimal heart failure therapy doses for at least 3 months
  • N-terminal pro B-type natriuretic peptide levels greater than 350 pg/mL
Not Eligible

You will not qualify if you...

  • Diagnosis of type 1 or type 2 diabetes or Hemoglobin A1c higher than 6.5%
  • Pregnancy or potential to become pregnant
  • Cancer
  • Liver dysfunction with enzyme levels more than 3 times the normal upper limit or high bilirubin
  • Kidney dysfunction with estimated glomerular filtration rate below 25 mL/min/1.73 m2
  • Hospitalization within the last 3 months for reasons other than heart failure
  • New York Heart Association functional class I or IV symptoms
  • Previous or planned bariatric surgery
  • Weight change greater than 11 lbs (5 kg) in the 3 months before enrollment
  • Acute or chronic infection

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Greenstone Biosciences

Palo Alto, California, United States, 94304

Actively Recruiting

2

Stanford Cardiovascular Institute

Stanford, California, United States, 94305

Actively Recruiting

3

University Medical Center Ljubljana

Ljubljana, Slovenia, 1000

Actively Recruiting

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Research Team

B

Bojan Vrtovec, MD, PhD

CONTACT

S

Sabina Frljak, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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