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NCT06914102 · ClinicalTrials.gov registry record
Emulation of the STEP-HFpEF DM Heart Failure Trial in Healthcare Claims Data
A clinical trial of Diabetes Mellitus, Type 2 and HFpEF - Heart Failure With Preserved Ejection Fraction, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- 58,387
- Enrollment target
- 1
- Study location
NCT06914102: Completed study of Diabetes Mellitus, Type 2 and HFpEF - Heart Failure With Preserved Ejection Fraction, sponsored by Brigham and Women's Hospital.
NCT06914102 is a study of Diabetes Mellitus, Type 2 and HFpEF - Heart Failure With Preserved Ejection Fraction that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 58,387 participants, above the 4,318-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (1252% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06914102, a study of Diabetes Mellitus, Type 2 and HFpEF - Heart Failure With Preserved Ejection Fraction, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- 58,387 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
To evaluate the effect of semgalutide vs placebo (sitaglitpin) on composite of all-cause mortality or heart failure hospitalization in two populations (1) patients meeting the eligibility criteria of the STEP-HFpEF DM trial, and (2) a broader patient population when relaxing the eligibility criteria of the STEP-HFpEF DM trial.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Semaglutide
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58,387 participants |
| Start Date | 2025-01-14 |
| Est. Completion | 2025-06-01 |
What the finished NCT06914102 record still lists
NCT06914102 is an observational study that tracks outcomes without assigning an intervention. Its 58,387 participants enrollment target places it among the larger protocols in the corpus, above the 4,318-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (1252% higher).
The record links to 2 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06914102 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06914102 about?
NCT06914102 is a clinical study titled "Emulation of the STEP-HFpEF DM Heart Failure Trial in Healthcare Claims Data". 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 s...
What is the current status of trial NCT06914102?
This trial is currently completed. The enrollment target is 58,387 participants. The study started on 2025-01-14. Estimated completion is 2025-06-01.
What conditions does trial NCT06914102 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, HFpEF - Heart Failure With Preserved Ejection Fraction.
What interventions are being tested in trial NCT06914102?
The interventions under investigation include: Placebo (DRUG), Semaglutide (DRUG).
Who is sponsoring clinical trial NCT06914102?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06914102 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 2
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06914102's enrollment target sits among peer trials
58,387 6th of 348 higher than 343 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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