Semaglutide for Heart Failure and Obesity

This study is looking at how Semaglutide, a medication often used for type 2 diabetes, works in people with heart failure and obesity. Researchers want to understand its effects beyond what we already know. You might be able to join if you are between 20 and 80 years old, have heart failure and a body-mass index (BMI) of 27 or higher, and are not diabetic. The study will measure specific markers in your blood, like Interleukin-6 (IL-6), Interleukin-8 (IL-8), and Tumor Necrosis Factor-alpha (TNF-α), after 4 months to see how Semaglutide affects them. The study is currently unclear on its recruitment status and plans to enroll 10 patients.

Study design
This is an interventional study, meaning participants will receive Semaglutide. It will include 10 patients with heart failure and obesity.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Blood markers will be measured at 4 months after starting the intervention.

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NCT06541509

Mechanisms of Semaglutide Therapy in Heart Failure Patients

UNKNOWN
PHASE1Ages 20–80InterventionalTreatment
University Medical Centre Ljubljana
~10 participants
Updated 2024-08-07 on ClinicalTrials.gov
What's tested:Semaglutide

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Interleukin-6 (IL-6)
Measured over 4 months
+10 more outcomes measured
Heart Failure
Obesity
3 sites across 2 states
California2
Slovenia1

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Eligibility criteria

Inclusion

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

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 \> 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
  • Interleukin-6 (IL-6)4 months

    Measured using enzyme linked immunosorbent assay (ELISA). Units of Measure: picograms per milliliter (pg/mL).

  • Interleukin-8 (IL-8)4 months

    Measured using ELISA. Units of Measure: picograms per milliliter (pg/mL).

  • Tumor Necrosis Factor-alpha (TNF-α)4 months

    Measured using ELISA. Units of Measure: picograms per milliliter (pg/mL).

  • Interferon-gamma (IFN-γ)4 months

    Measured using ELISA. Units of Measure: picograms per milliliter (pg/mL).

  • B-type Natriuretic Peptide (BNP)4 months

    Measured using immunoassay. Units of Measure: picograms per milliliter (pg/mL).

  • C-reactive Protein (CRP)4 months

    Measured using immunoassay. Units of Measure: picograms per milliliter (pg/mL).

  • Hemoglobin A1C (HgA1C)4 months

    Measured using standard laboratory methods. Units of Measure: percent (%).

  • Complete Blood Count (CBC)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)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)4 months

    Measured using standard laboratory methods. LFT parameters will be measured in their respective units (e.g., mg/dL, U/L).

  • Body mass index4 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.