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

Description

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).

Conditions

Heart Failure With Reduced Ejection Fraction, Congestion

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Study Overview

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Study Details

Study overview

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).

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)

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

Condition
Heart Failure With Reduced Ejection Fraction
Intervention / Treatment

-

Contacts and Locations

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Icahn School of Medicine at Mount Sinai,

Carlos G Santos-Gallego, MD, PRINCIPAL_INVESTIGATOR, Icanh School of Medicine at Mount Sinai

Study Record Dates

2024-12