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

NCT05152940 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: PD21-12423
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Heart Failure With Reduced Ejection Fraction; Congestion

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in the skin water content

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

  Baseline and One month

Secondary Outcomes (10)

• Change in skin sodium content

  Baseline and One month

• Change in interstitial Fluid

  Baseline and One month

• Change in pulmonary fluid

  Baseline and One month

• Change in the number of pulmonary Kerley's B-lines

  Baseline and One month

• Change in the plasma volume

  Baseline and One month

Study Arms (2)

Ertugliflozin then Placebo

ACTIVE COMPARATOR

Treatment with Ertugliflozin for one month, washout period for one month, and then with Placebo for one month

Drug: Ertugliflozin; Drug: Placebo

Placebo

ACTIVE COMPARATOR

Treatment with matching placebo for one month, washout period for one month, and then Ertugliflozin for one month

Drug: Ertugliflozin; Drug: Placebo

Interventions

Ertugliflozin DRUG

Treatment with Ertugliflozin 5 mg oral once per day for one month

Ertugliflozin then Placebo; Placebo

Placebo DRUG

Treatment with matching placebo to ertugliflozin administered orally once daily for a period of one month

Ertugliflozin then Placebo; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Interventions

ertugliflozin

Study Officials

• Carlos G Santos-Gallego, MD

  Icanh School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos G Santos-Gallego, MD

CONTACT

2122418484; carlos.santos-gallego@mssm.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 10, 2021
• Study Start: March 20, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Beginning 9 months and ending 36 months following article publication.

Locations

US (1)