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NCT06507657 · ClinicalTrials.gov registry record · Early Phase 1
Effect of Empagliflozin on Left Atrial Function in Adults at Risk for Heart Failure
A Early Phase 1 study of Hypertension and Cardiovascular Diseases, sponsored by University of Minnesota.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT06507657: Recruiting Early Phase 1 study of Hypertension and Cardiovascular Diseases, sponsored by University of Minnesota.
NCT06507657 is a Early Phase 1 study of Hypertension and Cardiovascular Diseases that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 80 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06507657, a Early Phase 1 study of Hypertension and Cardiovascular Diseases, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
Sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce CVD events, including incident HF. SGLT2 is a glucose transport protein in the kidneys. Inhibition of this protein results in glucosuria and lower serum blood sugar. The SGLT2i medications were initially approved to treat type 2 diabetes (T2D). In 2015, Zinman et al. published the first large randomized clinical trial (RCT) demonstrating a lower composite CVD outcome in adults with T2D treated with empagliflozin compared to placebo (HR 0.85, 95% CI 0.74-0.99). In the specific case of empagliflozin, the hazard ratio was 0.75 (95% CI 0.65-0.86) for HFrEF 8 and 0.79 (95% CI 0.69-0.90) for HFpEF using a treatment dose of 10mg daily. The purpose of this placebo-controlled, double-blinded, randomized pilot study is to investigate the effect of empagliflozin on left atrial (LA) function in 80 patients who are at risk for heart failure. Participants will be randomized 1:1 to either intake of a 10mg empagliflozin oral tablet or a matching placebo once daily.
Primary Outcome
LA function will be quantified by assessing LA reservoir, conduit, and contractile strain with 2DE at baseline and 9 months.
Conditions Studied
Interventions
- DRUG Placebo tablet
- DRUG empagliflozin
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2024-12-12 |
| Est. Completion | 2029-01-15 |
| Phase | Early Phase 1 |
What NCT06507657 shows while recruiting
NCT06507657 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Placebo tablet is the first listed.
NCT06507657 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT06507657 about?
NCT06507657 is a clinical study titled "Effect of Empagliflozin on Left Atrial Function in Adults at Risk for Heart Failure". Sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce CVD events, including incident HF. SGLT2 is a glucose transport protein in the kidneys. Inhibition of this protein results in glucosuria and lower serum blood sugar. The SGLT2i medications were initially approved to treat type 2 diabetes (T2D...
What is the current status of trial NCT06507657?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 80 participants. The study started on 2024-12-12. Estimated completion is 2029-01-15.
What conditions does trial NCT06507657 study?
This clinical trial studies the following conditions: Hypertension, Cardiovascular Diseases.
What interventions are being tested in trial NCT06507657?
The interventions under investigation include: Placebo tablet (DRUG), empagliflozin (DRUG).
Who is sponsoring clinical trial NCT06507657?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06507657 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06507657's enrollment target sits among peer trials
80 316th of 470 higher than 150 of 470 other Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension 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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