RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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)

Quick Facts

Study Start:2023-03-20
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05152940

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * age \>18 years;
  2. * males and females (females of child bearing potential must be using adequate contraceptive precautions)
  3. * diagnosis of heart failure (New York Heart Association \[NYHA\] functional class II to III);
  4. * Left ventricular ejection fraction \<40%;
  5. * stable symptoms and medical therapy within the last month.
  6. * Informed consent has to be given in written form
  1. * taking SGLT2i in the last month
  2. * acute coronary syndrome or cardiac surgery within the last month;
  3. * estimated glomerular filtration rate \<20 ml/kg/min;
  4. * use of continuous parental inotropic agents;
  5. * systolic blood pressure \<90 mm Hg;
  6. * LVAD implantation or cardiac transplantation
  7. * pregnant or lactating women; and
  8. * any other medical condition considered unappropriated by a study physician

Contacts and Locations

Study Contact

Carlos G Santos-Gallego, MD
CONTACT
2122418484
carlos.santos-gallego@mssm.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-20
Study Completion Date2024-12

Study Record Updates

Study Start Date2023-03-20
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • SGLT2 inhibitors
  • heart failure with reduced ejection fraction
  • congestion
  • sodium

Additional Relevant MeSH Terms

  • Heart Failure With Reduced Ejection Fraction
  • Congestion