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GLP-1 Receptor Agonist

Semaglutide for Heart Failure (SEMAHEART Trial)

Phase 1 & 2
Recruiting
Research Sponsored by University Medical Centre Ljubljana
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of heart failure
Body-mass index 27 kg/m2 or greater
Must not have
Renal dysfunction (estimated glomerular filtration rate less than 25 mL/min/1.73 m2)
Prior or planned bariatric surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights

Summary

"This trial aims to study how semaglutide, a drug used for treating type-2 diabetes, benefits patients with heart failure. Previous studies have shown that semaglutide can improve outcomes in

Who is the study for?
This trial is for heart failure patients who are also obese. It's exploring how a diabetes medication, Semaglutide, can help them. To join, participants must meet certain health conditions but the specific inclusion and exclusion criteria aren't provided here.
What is being tested?
The study tests Semaglutide, a drug used for type-2 diabetes that affects insulin and other hormones. Researchers want to understand why it helps with heart failure and reduces hospital visits for these patients.
What are the potential side effects?
While not detailed in this summary, Semaglutide may cause digestive issues like nausea or diarrhea, risk of low blood sugar levels if taken with other diabetes medications, and possible pancreatitis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have heart failure.
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My BMI is 27 or higher.
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I am between 20 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function is very low.
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I have had or am planning to have weight loss surgery.
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I have diabetes or my A1C level is above 6.5%.
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My liver tests are significantly higher than normal.
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I am currently dealing with an infection.
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My heart condition causes no or severe limitations in physical activity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
B-type Natriuretic Peptide (BNP)
Body mass index
C-reactive Protein (CRP)
+8 more
Secondary study objectives
Exercise capacity
Fat mass
Global longitudinal strain (GLS)
+6 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
21%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study

Trial Design

1Treatment groups
Experimental Treatment
Group I: Semaglutide TherapyExperimental Treatment1 Intervention
Timepoints: * Baseline (Week 0) * Week 2 (Visit 1) * Week 4 (Visit 2) * Week 12 (Visit 3) * Week 16 (Visit 4) Medication Schedule: Subcutaneous semaglutide (Ozempyc, Novo Nordisk A/S Bagsvaerd, Denmark) First 2 weeks: Semaglutide; 0.25 mg weekly Second 2 weeks: Semaglutide; 0.5 mg weekly Remaining 12 weeks: Semaglutide; 1 mg weekly
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2021
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

Greenstone BiosciencesUNKNOWN
1 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Heart Failure
40 Patients Enrolled for Heart Failure
Stanford UniversityOTHER
2,448 Previous Clinical Trials
17,492,384 Total Patients Enrolled
20 Trials studying Heart Failure
56,418 Patients Enrolled for Heart Failure
University Medical Centre LjubljanaLead Sponsor
268 Previous Clinical Trials
69,650 Total Patients Enrolled
9 Trials studying Heart Failure
650 Patients Enrolled for Heart Failure
~7 spots leftby Jul 2025
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