Comparative Effectiveness of Tirzepatide Versus Semaglutide in Individuals With Heart Failure With Preserved Ejection Fraction
Comparing Tirzepatide and Semaglutide for Heart Failure with Preserved Ejection Fraction
Plain English Summary
Comparative Effectiveness of Tirzepatide Versus Semaglutide in Individuals With Heart Failure With Preserved Ejection Fraction is a Not Applicable clinical trial sponsored by Brigham and Women's Hospital studying Diabetes Mellitus, Type 2, HFpEF - Heart Failure With Preserved Ejection Fraction. This study compares two diabetes medications, Tirzepatide and Semaglutide, in people with type 2 diabetes and a specific type of heart failure (HFpEF). It is for adults with type 2 diabetes, obesity (BMI > 27), and heart failure with preserved ejection fraction (LVEF >= 45%). Participation involves analyzing existing health records; no new treatments are given. Alternatives include standard diabetes and heart failure management, and other medications not specifically studied here. The trial aims to enroll 28118 participants.
Official Summary
Investigators are building an empirical evidence base for real-world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 18 or older, have type 2 diabetes, a BMI over 27, and a specific type of heart failure (HFpEF). You cannot join if you have type 1 diabetes, severe kidney disease, have had bariatric surgery, or are pregnant or breastfeeding. You also cannot join if you have previously used GLP-1 receptor agonists (like Semaglutide or Tirzepatide), have certain eye conditions related to diabetes, or have had certain types of cancer within the last 5 years. This trial is studying Diabetes Mellitus, Type 2, HFpEF - Heart Failure With Preserved Ejection Fraction, so participants generally need a confirmed diagnosis.
What They're Measuring
The main goal is to see if Tirzepatide or Semaglutide is better at preventing death or hospitalization due to heart failure in patients with this condition. The specific primary outcome measures are: Composite of all-cause mortality or heart failure hospitalization (Through study completion (1 day after cohort entry date until the first of outcome or censoring)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it will provide real-world evidence on how two popular diabetes drugs compare in treating patients with both type 2 diabetes and heart failure with preserved ejection fracti This research targets Diabetes Mellitus, Type 2, HFpEF - Heart Failure With Preserved Ejection Fraction, where improved treatment options are needed.
Investor Insight
This observational study leverages large datasets to compare two widely used diabetes medications, indicating a significant market for treatments addressing both diabetes and heart failure, with high The large enrollment target of 28118 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if these medications are right for you, considering your diabetes and heart health. This study uses existing health data, so your day-to-day involvement is minimal, focusing on your regular medical care. Your doctor will review your medical history to see if you meet the study's criteria. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 28,118 participants
Interventions
- DRUG: Tirzepatide — New use of tirzepatide dispensing claim is used as the exposure.
- DRUG: Semaglutide — New use of semaglutide dispensing claim is used as the reference.
Primary Outcomes
- Composite of all-cause mortality or heart failure hospitalization (Through study completion (1 day after cohort entry date until the first of outcome or censoring))
Secondary Outcomes
- Composite of all-cause mortality or all-cause mortality or a worsening heart failure event (exacerbated symptoms of heart failure resulting in hospitalization, intravenous diuretic therapy in an urgent care setting). (Through study completion (1 day after cohort entry date until the first of outcome or censoring))
- Worsening heart failure event (exacerbated symptoms of heart failure resulting in hospitalization or intravenous diuretic therapy in an urgent care setting). (Through study completion (1 day after cohort entry date until the first of outcome or censoring))
- Intravenous diuretic therapy in an urgent care setting (Through study completion (1 day after cohort entry date until the first of outcome or censoring))
- Hospitalization for heart failure (Through study completion (1 day after cohort entry date until the first of outcome or censoring))
- All-cause mortality (Through study completion (1 day after cohort entry date until the first of outcome or censoring))
Full Eligibility Criteria
Eligible cohort entry dates: Optum: Study period between May 13, 2022 to November 30, 2024. Marketscan: Study period between May 13, 2022 to December 31, 2023. Inclusion Criteria: * Heart failure * BMI \> 27.0 kg/m2 * History of type 2 diabetes mellitus * LVEF ≥ 45% * ≥ 18 years old, male or female sex Exclusion Criteria: * Prior treatment with any GLP-1-RA * History of type 1 diabetes mellitus * End-stage renal disease or chronic or intermittent haemodialysis or peritoneal dialysis * History of bariatric surgery * History of nursing home admission * Pregnant female or breastfeeding * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy * Treatment with continuous subcutaneous insulin infusion * Multiple endocrine neoplasia type 2 or medullary thyroid carcinoma * Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous-cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) for less than 5 years
Trial Locations
- Brigham and Women's Hospital, Boston, Massachusetts, United States
Frequently Asked Questions
What is clinical trial NCT06914141?
NCT06914141 is a Not Applicable OBSERVATIONAL study titled "Comparative Effectiveness of Tirzepatide Versus Semaglutide in Individuals With Heart Failure With Preserved Ejection Fraction." It is currently completed and is sponsored by Brigham and Women's Hospital. The trial targets enrollment of 28118 participants.
What conditions does NCT06914141 study?
This trial investigates treatments for Diabetes Mellitus, Type 2, HFpEF - Heart Failure With Preserved Ejection Fraction. The primary condition under study is Diabetes Mellitus, Type 2.
What treatments are being tested in NCT06914141?
The interventions being studied include: Tirzepatide (DRUG), Semaglutide (DRUG). New use of tirzepatide dispensing claim is used as the exposure.
What does Not Applicable mean for NCT06914141?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT06914141?
This trial is currently "Completed." It started on 2025-01-14. The estimated completion date is 2025-06-01.
Who is sponsoring NCT06914141?
NCT06914141 is sponsored by Brigham and Women's Hospital. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06914141?
The trial aims to enroll 28118 participants. The trial status is completed.
How is NCT06914141 designed?
This is a observational study.
What are the primary outcomes being measured in NCT06914141?
The primary outcome measures are: Composite of all-cause mortality or heart failure hospitalization (Through study completion (1 day after cohort entry date until the first of outcome or censoring)). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06914141 being conducted?
This trial is being conducted at 1 site, including Boston, Massachusetts (United States).
Where can I find official information about NCT06914141?
The official record for NCT06914141 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06914141. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06914141 testing in simple terms?
This study compares two diabetes medications, Tirzepatide and Semaglutide, in people with type 2 diabetes and a specific type of heart failure (HFpEF). It is for adults with type 2 diabetes, obesity (BMI > 27), and heart failure with preserved ejection fraction (LVEF >= 45%).
Why is this trial significant?
This trial matters because it will provide real-world evidence on how two popular diabetes drugs compare in treating patients with both type 2 diabetes and heart failure with preserved ejection fracti
What are the potential risks of participating in NCT06914141?
Potential side effects of these medications can include nausea, vomiting, diarrhea, and constipation. Less common but serious risks may involve pancreatitis, gallbladder problems, or kidney issues. As this is an observational study using existing data, the risks are primarily those associated with the medications themselves, not the study procedures. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06914141?
Ask your doctor if these medications are right for you, considering your diabetes and heart health. This study uses existing health data, so your day-to-day involvement is minimal, focusing on your regular medical care. Your doctor will review your medical history to see if you meet the study's criteria. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06914141 signal from an investment perspective?
This observational study leverages large datasets to compare two widely used diabetes medications, indicating a significant market for treatments addressing both diabetes and heart failure, with high This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves analyzing existing health records; no new treatments are given. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.