Diabetes Mellitus, Type 2DUP-SUMMITNCT06914154
Emulation of the SUMMIT Heart Failure Trial in Healthcare Claims Data
An observational study of Diabetes Mellitus, Type 2 and Heart Failure With Preserved Ejection Fraction (HFPEF), run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Heart Failure With Preserved Ejection Fraction (HFPEF)
- What is being tested?
- Tirzepatide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11,265 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2025to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population included individuals aged 40 years or older with heart failure with preserved ejection fraction.
Who may be able to join
- ≥ 40 years old, male or female sex
- Chronic heart failure (NYHA Class II-IV) diagnosed for at least 3 months before Visit 1
- LVEF ≥50% demonstrated by echocardiogram performed at Visit 1 or within 6 months of Visit 1
- Structural heart disease
- Either one of: (1) eGFR <70 mL/min/1.73m2 at Visit 1, (2) HF decompensation within 12 months of Visit 1, defined as hospitalization for HF requiring IV diuretic treatment or urgent HF visit requiring IV diuretic treatment
- Stable dose of all concomitant HF medications (that is, beta blockers, ACEis, ARBs, and MRAs), except for oral diuretics, for at least 4 weeks prior to Visit 1 a
Show all 14Show fewer
- If treated with oral diuretics, dose must be stable for at least 2 weeks prior to Visit 1 and throughout the screening period; volume control must be optimally achieved in the opinion of the investigator
- BMI ≥27.0 kg/m2 at Visit 1
- Type 2 diabetes mellitus trial subgroup
- Men or women ≥ 40 years old
- History of type 2 diabetes mellitus
- BMI ≥ 27.0 kg/m2
- Heart failure
- Preserved ejection fraction
Who cannot join
- Myocardial infarction, coronary artery bypass graft surgery, or other major CV surgery/intervention, stroke or transient ischemic attack in past 90 days, or unstable angina pectoris in past 30 days, prior to Visit 1 or during screening
- Lung disease: pulmonary arterial hypertension, chronic thromboembolic pulmonary hypertension (CTEPH), or severe pulmonary disease including (COPD)
- Other medical conditions: severe anemia (hemoglobin level <9 g/dL) at Visit 1, untreated thyroid disease or TSH >4.0 mU/L at Visit 1, or significant musculoskeletal disease
- Orthopedic conditions that limit the ability to walk, such as severe arthritis in the leg, knee, hip injuries, hemiplegia, or amputation with artificial limb without stable prosthesis function
- Any condition that in the opinion of the investigator would interfere with the assessment of 6MWT
- LVEF <40% by local echocardiography documented any time within 2 years of Visit 1
Show all 38Show fewer
- Acute decompensated HF (exacerbation of HF) requiring IV diuretics, IV inotropes, or IV vasodilators, or left ventricular assist device (LVAD) within 4 weeks prior to Visit 1, and/or during the screening period until randomization
- Impaired renal function, defined as eGFR <15 mL/min/1.73 m2 (CKD-EPI) or requiring dialysis at Visit 1
- Any one of the following: (1) Systolic blood pressure (SBP) ≥180 mmHg at Visit 1 (2) SBP >160 mmHg both at Visit 1 and at Visit 2 (3) Have symptomatic hypotension or SBP <100 mmHg at Visit 1 or Visit 2
- Atrial fibrillation or atrial flutter with a resting heart rate >110 bpm documented by ECG at Visit 1
- Cardiac amyloidosis or cardiomyopathy based on accumulation disease (for example, haemochromatosis, Fabry disease), muscular dystrophy, cardiomyopathy with reversible causes (for example, stress cardiomyopathy), hypertrophic obstructive cardiomyopathy or known pericardial constriction, or any severe (obstructive or regurgitant) valvular heart disease likely to lead to surgery during the study period
- Completed prior surgical treatment for obesity or had liposuction or abdominoplasty within 1 year prior to Visit 1. Participants who plan to have surgical treatment for obesity or liposuction or abdominoplasty during the duration of the study are excluded.
- Have type 1 diabetes mellitus
- For type 2 diabetes mellitus (1) Have uncontrolled diabetes requiring immediate therapy (such as diabetic ketoacidosis) at Visit 1 or Visit 2, in the judgement of the physician (2) Have had 1 or more events of severe hypoglycemia and/or 1 or more events of hypoglycemia unawareness within 6 months prior to Visit 1 (see Section 10.5.1.1 for definition of hypoglycemia) (3) Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or severe nonproliferative diabetic retinopathy that requires acute treatment. Patients with T2DM should have had a dilated fundoscopic examination, performed by an ophthalmologist or optometrist, within 12 months of Visit 1 or prior to randomization (4) Treated with premix or prandial insulins or intensified insulin regimens (multiple daily injection with basal and prandial insulins or insulin pump therapy) at Visit 1
- History of acute or chronic pancreatitis or at high risk for acute pancreatitis (for example, serum triglyceride level >500 mg/dL
- Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease, or any of the following, as determined by the central laboratory during Visit 1: ALT or AST levels >2.5X the ULN for the reference range.
- Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome type 2
- 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
- Have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the investigator, may preclude the participant from following and completing the protocol
- Have a known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect GI motility
- Treatment with any incretin, GLP-1 RA, or pramlintide in the 3 months prior to Visit 1
- Implantable cardioverter defibrillator (ICD) implantation within 1 month prior to Visit 1 or planned implantation during the course of the study
- Currently implanted left ventricular assist device (LVAD)
- Cardiac resynchronization therapy (CRT) implanted within 6 months prior to Visit 1 or planned implantation during the course of the trial
- Current use of medication associated with weight gain or weight loss, except when on stable dose for at least 3 months prior to Visit 1, and expected to be stable during the study period
- Pregnancy
- RELAXING ELIGIBILITY OF THE SUMMIT TRIAL
- Prior treatment with any GLP-1-RA
- History of type 1 diabetes mellitus
- End-stage renal disease or chronic or intermittent hemodialysis or peritoneal dialysis
- History of bariatric surgery
- History of nursing home admission
- Pregnant female or breast-feeding
- 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
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
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.
Read the detailed description
This is a non-randomized, non-interventional study that is part of the Randomized Controlled Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology (RCT DUPLICATE) initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to emulate, as closely as is possible in healthcare insurance claims data, the SUMMIT trial described below. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. In addition to closely emulating the trial population, this study also evaluates outcomes in a broader, less restrictive cohort to enhance generalizability to patients typically encountered in routine clinical practice. Randomization cannot be achieved in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides guidance on the reference standard treatment effect estimate. However, failure to replicate RCT findings is not necessarily indicative of the inadequacy of the healthcare claims data for emulation for a range of possible reasons, as the end points examined in the database study were partly only of exploratory nature in the trial. Moreover, divergence from these end points do not provide information on the validity of the original RCT finding.
The SUMMIT trial is a superiority trial that included an evaluation of the effect of tirzepatide, a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist (RA), vs placebo on all-cause mortality or worsening heart failure events among individuals with heart failure with preserved ejection fraction.
The database study designed to emulate the type 2 diabetes mellitus (T2DM) subgroup of the SUMMIT trial will be a new-user active-comparative study, conducted using 2 national United States claims databases, where we compare the effect of tirzepatide vs sitagliptin, a dipeptidyl peptidase-4 inhibitor (DPP4i) on the composite end point of all-cause mortality or heart failure hospitalization. While the SUMMIT trial was conducted in participants with and without T2DM, both subgroups showed similar effect estimates in their results. Furthermore, while the trial compared tirzepatide vs placebo, we chose to use sitagliptin as an active-comparator proxy for placebo in the T2DM subgroup. Sitagliptin was specifically chosen because a major randomized controlled trial on cardiovascular outcomes demonstrated that the drug does not affect the cardiovascular outcomes under investigation. Furthermore, clinical guidelines during the study period recommended both drug classes under investigation as second- or third-line options for glucose lowering and were similarly costly.
- Being tested
- Tirzepatide, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
New use of tirzepatide dispensing claim is used as the exposure.
PlaceboDrug
New use of sitagliptin dispensing claim is used as the reference (active-comparator proxy for placebo).
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide | Exposure group Receives: Drug: Tirzepatide | |
| Placebo | Reference group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause mortality or heart failure hospitalisation.
To evaluate the comparative effect of tirzepatide vs placebo (sitagliptin) on all-cause mortality or heart failure hospitalization in patients with heart failure with preserved ejection fraction when following the eligibility criteria of the SUMMIT trial.
Measured: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
Composite of all-cause mortality or heart failure hospitalization.
To evaluate the comparative effect of tirzepatide vs placebo (sitagliptin) on all-cause mortality or heart failure hospitalization in patients with heart failure with preserved ejection fraction when relaxing the eligibility criteria of the SUMMIT trial.
Measured: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
Secondary outcomes (8)
Composite of all-cause mortality or all-cause mortality or a worsening heart failure event (exacerbated symptoms of heart failure resulting in hospitalization or intravenous diuretic therapy in an urgent care setting).
To evaluate the effect of tirzepatide vs placebo (sitagliptin) on composite of all-cause mortality or all-cause mortality or a worsening heart failure event (exacerbated symptoms of heart failure resulting in hospitalization or intravenous diuretic therapy in an urgent care setting). in two populations: (1) patients meeting the eligibility criteria of the SUMMIT trial, and (2) a broader patient population when relaxing the eligibility criteria of the SUMMIT trial.
Measured: 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).
To evaluate the effect of tirzepatide vs placebo (sitagliptin) on worsening heart failure event (exacerbated symptoms of heart failure resulting in hospitalization or intravenous diuretic therapy in an urgent care setting). in two populations: (1) patients meeting the eligibility criteria of the SUMMIT trial, and (2) a broader patient population when relaxing the eligibility criteria of the SUMMIT trial.
Measured: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
Intravenous diuretic therapy in an urgent care setting
To evaluate the effect of tirzepatide vs placebo (sitagliptin) on intravenous diuretic therapy in an urgent care setting in two populations: (1) patients meeting the eligibility criteria of the SUMMIT trial, and (2) a broader patient population when relaxing the eligibility criteria of the SUMMIT trial.
Measured: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
Hospitalization for heart failure
To evaluate the effect of tirzepatide vs placebo (sitagliptin) on hospitalization for heart failure in two populations: (1) patients meeting the eligibility criteria of the SUMMIT trial, and (2) a broader patient population when relaxing the eligibility criteria of the SUMMIT trial.
Measured: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
All-cause mortality
To evaluate the effect of tirzepatide vs placebo (sitagliptin) on all-cause mortality in two populations: (1) patients meeting the eligibility criteria of the SUMMIT trial, and (2) a broader patient population when relaxing the eligibility criteria of the SUMMIT trial.
Measured: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
Urinary tract infection
To evaluate the effect of tirzepatide vs placebo (sitagliptin) on Urinary tract infection in two populations: (1) patients meeting the eligibility criteria of the SUMMIT trial, and (2) a broader patient population when relaxing the eligibility criteria of the SUMMIT trial.
Measured: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
Serious bacterial infection
To evaluate the effect of tirzepatide vs placebo (sitagliptin) on serious bacterial infection in two populations: (1) patients meeting the eligibility criteria of the SUMMIT trial, and (2) a broader patient population when relaxing the eligibility criteria of the SUMMIT trial.
Measured: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
Gastrointestinal adverse effects
To evaluate the effect of tirzepatide vs placebo (sitagliptin) on gastrointestinal adverse effects in two populations: (1) patients meeting the eligibility criteria of the SUMMIT trial, and (2) a broader patient population when relaxing the eligibility criteria of the SUMMIT trial.
Measured: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start14 Jan 2025
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 11,265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shirley Vichy Wang, Brigham and Women's Hospital
- Investigators
- Shirley Wang, PhD, ScM, Principal investigator, Brigham and Women's HospitalNils Krüger, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914154
- Sponsor's protocol ID
- 2018P002966-DUP-SUMMIT
- Acronym
- DUP-SUMMIT
- Status last verified
- May 2025
- First submitted
- 31 Mar 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kruger N, Schneeweiss S, Fuse K, Matseyko S, Sreedhara SK, Hahn G, Schunkert H, Wang SV. Semaglutide and Tirzepatide in Patients With Heart Failure With Preserved Ejection Fraction. JAMA. 2025 Oct 14;334(14):1255-1266. doi: 10.1001/jama.2025.14092.
PubMed 40886075
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emulation of the SUMMIT Heart Failure Trial in Healthcare Claims Data
- ClinicalTrials.gov ID
- NCT06914154
- Acronym / sponsor ID
- DUP-SUMMIT / 2018P002966-DUP-SUMMIT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,265 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 14 Jan 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a non-randomized, non-interventional study that is part of the Randomized Controlled Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology (RCT DUPLICATE) initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to emulate, as closely as is possible in healthcare insurance claims data, the SUMMIT trial described below. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. In addition to closely emulating the trial population, this study also evaluates outcomes in a broader, less restrictive cohort to enhance generalizability to patients typically encountered in routine clinical practice. Randomization cannot be achieved in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides guidance on the reference standard treatment effect estimate. However, failure to replicate RCT findings is not necessarily indicative of the inadequacy of the healthcare claims data for emulation for a range of possible reasons, as the end points examined in the database study were partly only of exploratory nature in the trial. Moreover, divergence from these end points do not provide information on the validity of the original RCT finding.
The SUMMIT trial is a superiority trial that included an evaluation of the effect of tirzepatide, a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist (RA), vs placebo on all-cause mortality or worsening heart failure events among individuals with heart failure with preserved ejection fraction.
The database study designed to emulate the type 2 diabetes mellitus (T2DM) subgroup of the SUMMIT trial will be a new-user active-comparative study, conducted using 2 national United States claims databases, where we compare the effect of tirzepatide vs sitagliptin, a dipeptidyl peptidase-4 inhibitor (DPP4i) on the composite end point of all-cause mortality or heart failure hospitalization. While the SUMMIT trial was conducted in participants with and without T2DM, both subgroups showed similar effect estimates in their results. Furthermore, while the trial compared tirzepatide vs placebo, we chose to use sitagliptin as an active-comparator proxy for placebo in the T2DM subgroup. Sitagliptin was specifically chosen because a major randomized controlled trial on cardiovascular outcomes demonstrated that the drug does not affect the cardiovascular outcomes under investigation. Furthermore, clinical guidelines during the study period recommended both drug classes under investigation as second- or third-line options for glucose lowering and were similarly costly.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide | – | Drug: TirzepatideExposure group |
| Placebo | – | Drug: PlaceboReference group |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population included individuals aged 40 years or older with heart failure with preserved ejection fraction.
Key inclusion criteria (14 listed)
- ≥ 40 years old, male or female sex
- Chronic heart failure (NYHA Class II-IV) diagnosed for at least 3 months before Visit 1
- LVEF ≥50% demonstrated by echocardiogram performed at Visit 1 or within 6 months of Visit 1
- Structural heart disease
- Either one of: (1) eGFR <70 mL/min/1.73m2 at Visit 1, (2) HF decompensation within 12 months of Visit 1, defined as hospitalization for HF requiring IV diuretic treatment or urgent HF visit requiring IV diuretic treatment
Key exclusion criteria (38 listed)
- Myocardial infarction, coronary artery bypass graft surgery, or other major CV surgery/intervention, stroke or transient ischemic attack in past 90 days, or unstable angina pectoris in past 30 days, prior to Visit 1 or during screening
- Lung disease: pulmonary arterial hypertension, chronic thromboembolic pulmonary hypertension (CTEPH), or severe pulmonary disease including (COPD)
- Other medical conditions: severe anemia (hemoglobin level <9 g/dL) at Visit 1, untreated thyroid disease or TSH >4.0 mU/L at Visit 1, or significant musculoskeletal disease
- Orthopedic conditions that limit the ability to walk, such as severe arthritis in the leg, knee, hip injuries, hemiplegia, or amputation with artificial limb without stable prosthesis function
- Any condition that in the opinion of the investigator would interfere with the assessment of 6MWT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideNew use of tirzepatide dispensing claim is used as the exposure. | Drug | Tirzepatide |
| PlaceboNew use of sitagliptin dispensing claim is used as the reference (active-comparator proxy for placebo). | Drug | Placebo |
Primary outcome
Composite of all-cause mortality or heart failure hospitalisation.
Time frame: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
To evaluate the comparative effect of tirzepatide vs placebo (sitagliptin) on all-cause mortality or heart failure hospitalization in patients with heart failure with preserved ejection fraction when following the eligibility criteria of the SUMMIT trial.
Composite of all-cause mortality or heart failure hospitalization.
Time frame: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
To evaluate the comparative effect of tirzepatide vs placebo (sitagliptin) on all-cause mortality or heart failure hospitalization in patients with heart failure with preserved ejection fraction when relaxing the eligibility criteria of the SUMMIT trial.
8 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 or intravenous diuretic therapy in an urgent care setting).
Time frame: 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).
Time frame: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
Intravenous diuretic therapy in an urgent care setting
Time frame: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
Hospitalization for heart failure
Time frame: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
All-cause mortality
Time frame: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
Urinary tract infection
Time frame: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
Serious bacterial infection
Time frame: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
Gastrointestinal adverse effects
Time frame: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Derived from this study: PubMed 40886075Kruger N, Schneeweiss S, Fuse K, Matseyko S, Sreedhara SK, Hahn G, Schunkert H, Wang SV. Semaglutide and Tirzepatide in Patients With Heart Failure With Preserved Ejection Fraction. JAMA. 2025 Oct 14;334(14):1255-1266. doi: 10.1001/jama.2025.14092.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shirley Wang, PhD, ScM principal investigator
Brigham and Women's Hospital
Nils Krüger, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Heart Failure With Preserved Ejection Fraction (HFPEF), run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of all-cause mortality or heart failure hospitalisation. (time frame: Through study completion (1 day after cohort entry date until the first of outcome or censoring)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06914154, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.