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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 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.

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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.

Conditions Studied

Hypertension Cardiovascular Diseases

Interventions

  • DRUG Placebo tablet
  • DRUG empagliflozin

Study Locations (1)

Minnesota

  • University of Minnesota - Minneapolis

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2024-12-12
Est. Completion 2029-01-15
Phase Early Phase 1

Sponsor

University of Minnesota

966 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06507657

The ClinicalTrials.gov registry entry for NCT06507657 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (98% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.