Effects of Ertugliflozin on sodium and fluid levels in heart failure patients
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)
This study is testing if the medication Ertugliflozin can help people with heart failure manage their sodium and fluid levels better than a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05152940 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates how the SGLT2 inhibitor Ertugliflozin affects sodium storage and fluid levels in patients with heart failure with reduced ejection fraction (HFrEF). The study employs a randomized, cross-over design where participants will receive either Ertugliflozin or a placebo. Skin biopsies will be taken before and after treatment to measure sodium and water content, and an oral salt challenge will assess the drug's impact on congestion. The goal is to determine if Ertugliflozin can provide better congestion relief with minimal effects on blood volume.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a diagnosis of HFrEF and stable symptoms on medical therapy.
Not a fit: Patients with acute coronary syndrome, recent cardiac surgery, or those on continuous inotropic agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve congestion relief in heart failure patients while preserving blood volume and organ perfusion.
How similar studies have performed: While SGLT2 inhibitors have shown promise in heart failure management, this specific approach focusing on sodium storage and interstitial fluid is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Carlos G Santos-Gallego, MD — Icanh School of Medicine at Mount Sinai
- Study coordinator: Carlos G Santos-Gallego, MD
- Email: carlos.santos-gallego@mssm.edu
- Phone: 2122418484
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.