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NCT05152940 · ClinicalTrials.gov registry record · Phase 4

ERTU-SODIUM: Study on the Effects of Ertugliflozin on Sodium Storage, Interstitial Volume, and Plasma Volume in HFrEF

A Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.

Completed
Registry status
Phase 4
Development phase
28
Enrollment target

NCT05152940: Completed Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.

NCT05152940 is a Phase 4 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 28 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05152940, a Phase 4 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.

COMPLETED
Registry status
Phase 4
Development phase
28 participants
Enrollment target

Study Summary

The overall hypothesis is that treatment with the SGLT2 inhibitor Ertugliflozin induces a differential regulation in interstitial fluid vs plasma volume, with more reduction of the volume from the interstitial fluid than from the circulating plasma volume, which results in Ertugliflozin inducing more potent congestion relief with minimal impact on blood volume and organ perfusion. Ertugliflozin reduces the levels of sodium and water from the skin and the interstitial tissue (which improves tissue congestion).

Primary Outcome

Skin water content is measured as total (wet) weight - dry weight, determined after desiccation at 90°C for 24 hours to stable weight

Interventions

  • DRUG Placebo
  • DRUG Ertugliflozin

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2023-02-02
Est. Completion 2023-10-27
Phase Phase 4

What the finished NCT05152940 record still lists

NCT05152940 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT05152940 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05152940 about?

NCT05152940 is a clinical study titled "ERTU-SODIUM: Study on the Effects of Ertugliflozin on Sodium Storage, Interstitial Volume, and Plasma Volume in HFrEF". The overall hypothesis is that treatment with the SGLT2 inhibitor Ertugliflozin induces a differential regulation in interstitial fluid vs plasma volume, with more reduction of the volume from the interstitial fluid than from the circulating plasma volume, which results in Ertugliflozin inducing mor...

What is the current status of trial NCT05152940?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 28 participants. The study started on 2023-02-02. Estimated completion is 2023-10-27.

What interventions are being tested in trial NCT05152940?

The interventions under investigation include: Placebo (DRUG), Ertugliflozin (DRUG).

Who is sponsoring clinical trial NCT05152940?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05152940's enrollment target sits among peer trials

28 1635th of 2000 higher than 350 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05152940, the US trial registry maintained by the National Library of Medicine. NCT05152940 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.