NCT07599293Completed
Emulation of the EMPEROR-Preserved Trial Using Healthcare Claims Data
Source: ClinicalTrials.gov · Last updated 9 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 39614 (actual)
- First submitted
- 14 May 2026
- Start date
- 13 Oct 2024
- Primary completion date
- 19 Jun 2026
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Heart failure, Type 2 diabetes
- NCT number
- NCT07599293
What you commit to
- Study type: Observational
- Participants enrolled: 39614
- From 13 Oct 2024 to the primary completion date, 19 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent use of both study drugs on cohort entry date
- Major surgery
- Chronic alcohol and or drug abuse
Other illness
- MI, CABG or other major cardiovascular surgery, GI surgery or disorder, stroke or TIA
- Implantable cardiac defibrillator
- GI surgery or disorder
- Cancer
- Heart transplant
- Liver disease
- Hypertension
- History of ketoacidosis
- Valvular heart disease
- Chronic pulmonary disease
Other
- Hypotension
- Pacemaker
- Atrial fibrillation
- Impaired renal function
- Anemia
- Pregnancy
- Cardiomyopathy
- Combined comorbidity score
- Noncompliance
- Acute decompensated HF
- Use of SGLT2i or DPP4i
Who the study is looking for
- At least 18 years of age
- Heart failure with preserved ejection fraction
- Structural heart disease
- Previous HHF
- BMI \< 45 kg/m2
- Type 2 diabetes mellitus
- Use of oral diuretics
Criteria the registry did not label
- Study period:
- Optum: Eligible cohort entry period from August 1, 2014 to August 31, 2024. Marketscan: Eligible cohort entry period from August 1, 2014 to September 31, 2023.
- Medicare: Eligible cohort entry period from August 1, 2014 to September 31, 2020.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.