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

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Treatments: Ertugliflozin

Criteria

Inclusion criteria:

• age >18 years;

• males and females (females of child bearing potential must be using adequate contraceptive precautions)

• diagnosis of heart failure (New York Heart Association [NYHA] functional class II to III);

• Left ventricular ejection fraction <40%;

• stable symptoms and medical therapy within the last month.

• Informed consent has to be given in written form

Exclusion criteria:

• taking SGLT2i in the last month

• acute coronary syndrome or cardiac surgery within the last month;

• estimated glomerular filtration rate <20 ml/kg/min;

• use of continuous parental inotropic agents;

• systolic blood pressure <90 mm Hg;

• LVAD implantation or cardiac transplantation

• pregnant or lactating women; and

• any other medical condition considered unappropriated by a study physician