CLINICAL TRIAL

Semaglutide for Heart Failure

Class II
Recruiting · 18+ · All Sexes · Baja, Hungary

Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity

See full description

About the trial for Heart Failure

Eligible Conditions
Heart Failure · Obesity

Treatment Groups

This trial involves 2 different treatments. Semaglutide is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Semaglutide
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo (semaglutide)
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
FDA approved

Side Effect Profile for Overall Study

Overall Study
Show all side effects
21%
Nausea
12%
Decreased Appetite
Nausea
21%
Decreased Appetite
12%
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT04189848) in the Overall Study ARM group. Side effects include: Nausea with 21%, Decreased Appetite with 12%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Body mass index (BMI) greater than or equal to 30.0 kg/m^2
New York Heart Association (NYHA) Class II-IV
Male or female, age above or equal to 18 years at the time of signing informed consent.
Left ventricular ejection fraction (LVEF) greater than or equal to 45 percentage at screening
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: From baseline (week -2) to end of treatment (week 52)
Screening: ~3 weeks
Treatment: Varies
Reporting: From baseline (week -2) to end of treatment (week 52)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From baseline (week -2) to end of treatment (week 52).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Semaglutide will improve 2 primary outcomes and 9 secondary outcomes in patients with Heart Failure. Measurement will happen over the course of From baseline (week 0) to end of treatment (visit 52).

Change in waist circumference
FROM BASELINE (WEEK 0) TO END OF TREATMENT (VISIT 52)
cm
FROM BASELINE (WEEK 0) TO END OF TREATMENT (VISIT 52)
Subject improving 10 points or more in KCCQ clinical summary score (Yes/No)
FROM BASELINE (WEEK 0) TO END OF TREATMENT (WEEK 52)
Count of subjects
FROM BASELINE (WEEK 0) TO END OF TREATMENT (WEEK 52)
Subject achieving 15 percentage weight loss or more (Yes/No)
FROM BASELINE (WEEK 0) TO END OF TREATMENT (WEEK 52)
Count of subjects
FROM BASELINE (WEEK 0) TO END OF TREATMENT (WEEK 52)
Change in KCCQ (Kansas City Cardiomyopathy Questionnaire ) clinical summary score
FROM BASELINE (WEEK 0) TO END OF TREATMENT (WEEK 52)
Score (no unit, range; 0-100 where the score 100 means the least burden for the participant)
FROM BASELINE (WEEK 0) TO END OF TREATMENT (WEEK 52)
Subject achieving 10 percentage weight loss or more (Yes/No)
FROM BASELINE (WEEK 0) TO END OF TREATMENT (WEEK 52)
Count of subjects
FROM BASELINE (WEEK 0) TO END OF TREATMENT (WEEK 52)
Subject improving 5 points or more in KCCQ clinical summary score (Yes/No)
FROM BASELINE (WEEK 0) TO END OF TREATMENT (WEEK 52)
Count of subjects
FROM BASELINE (WEEK 0) TO END OF TREATMENT (WEEK 52)
See More

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes heart failure?

Heart failure is usually not the result of a single specific cause. heart failure can result from a combination of causes, including coronary artery disease and cardiomyopathy.\n

Anonymous Patient Answer

What are common treatments for heart failure?

There is no single treatment for heart failure. Treatment may range from medications to surgery, pacemakers, or transcutaneous/artificial left/right ventricular assist pumps, among other options. Some of the treatments (e.g. pacemakers or ventricular assist pump) can be combined using a device called a dual-chamber pacemaker. Some heart failure treatment guidelines recommend combining medication, device therapy, exercise, or surgery in some cases.

Anonymous Patient Answer

What is heart failure?

Heart failure is a medical condition that can be caused by an interruption in the normal physiological functioning of the heart, most commonly by the heart muscle not pumping efficiently.\n

Anonymous Patient Answer

Can heart failure be cured?

Heart failure patients may have reduced survival rates as compared to a comparison group, but these differences are similar to those that exist within the general population. There is no difference in survival rates between patients receiving treatment or those left untreated.

Anonymous Patient Answer

How many people get heart failure a year in the United States?

Only 1 in 28,000 new Americans suffers from acute heart failure each year. But this number can rise dramatically in the next year and may reach 2 in 3,000 every year. Even a very mild grade of heart failure in a person with no prior cardiovascular disease raises the prospect of high-risk morbidity and mortality.

Anonymous Patient Answer

What are the signs of heart failure?

There are many different signs and symptoms of heart failure. Some of the common ones are shortness of breath or chest pain, or palpitations.\n\n- Advanced Symptoms"

"Eugenia baehrii\n\nEugenia baehrii is a species of plant in the family Myrtaceae. It is a native of New Caledonia.

Anonymous Patient Answer

How does semaglutide work?

Semaglutide is a GLP-1 (glucagon-like peptide 1) analog for once-weekly subcutaneous injection without food intake. When administered once-weekly, semaglutide is efficacious and well-tolerated in adults with the long-term glucagon analogs.

Anonymous Patient Answer

Is semaglutide safe for people?

Semaglutide is generally well-tolerated in people with type 2 diabetes. Most adverse events were mild to moderate and were not serious. There was no evidence of accelerated fracture healing after semaglutide therapy and no evidence that semaglutide increased the risk of cancer or cardiovascular events. Clinical trial registration NCT01811478.

Anonymous Patient Answer

Who should consider clinical trials for heart failure?

Given our inability to predict which patients respond to treatments or benefit from treatments, it comes as no surprise that patient opinion and their own perception of what treatment is best for them are the most important predictors of treatment decision-making. For individuals who have left ventricular dysfunction, their view of the benefit of particular drugs is a much more important consideration than what current evidence suggests as to the efficacy of the drug. Furthermore, for many individuals the only evidence of efficacy comes from patient data that has been pooled from several clinical trials. This suggests that individualised treatment, based on the individual patient's view of benefit and the efficacy of treatment will be the only way forward.

Anonymous Patient Answer

Have there been other clinical trials involving semaglutide?

Results from a recent paper is the first description of a semaglutide trial in a population with Type 2 diabetes that was mainly supported using exogenous insulin to control blood glucose. This represents a significant extension of the clinical efficacy of semaglutide to include a subset of patients with Type 2 diabetes for whom other treatments are inadequate. A similar trend was noted with body weight reductions. A larger trial of this medication will prove important as it may support the use of semaglutide over injectable and oral insulin therapy for a patient population that has few options.

Anonymous Patient Answer

What are the latest developments in semaglutide for therapeutic use?

SGLT2 is a promising therapeutic agent for hyperglycemia with or without diabetes, for which new therapies are sorely needed. Its potential role for treatment of type 2 diabetes is particularly promising given the increasing prevalence of obesity and associated insulin resistance.

Anonymous Patient Answer

Have there been any new discoveries for treating heart failure?

At present, we have little knowledge about the process by which heart failure develops and the mechanisms of the disease and as we progress our understanding of these things will likely influence both research as well as clinical practice to better the current management of the disease.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Heart Failure by sharing your contact details with the study coordinator.