ERTU-SODIUM: Double-blind, Prospective, Randomized, Crossover, Placebo-control Study on the Effects of the SGLT2 Inhibitor Ertugliflozin on the Regulation of Interstitial Volume, Plasma Volume, Subcutaneous Sodium Storage, and the Functionality of the Subcutaneous Glycosaminoglycan Network in Patients With Heart Failure With Reduced Ejection Fraction (HFrEF)

NCT05152940 Phase 4 COMPLETED

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).

Details

Lead sponsor	Icahn School of Medicine at Mount Sinai
Phase	Phase 4
Status	COMPLETED
Enrolment	28
Start date	2023-02-02
Completion	2023-10-27

Conditions

• Heart Failure With Reduced Ejection Fraction
• Congestion

Interventions

• Ertugliflozin
• Placebo

Primary outcomes

• Change in the skin water content — Baseline and One month
  Skin water content is measured as total (wet) weight - dry weight, determined after desiccation at 90°C for 24 hours to stable weight

Countries

United States