Clinical trial
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)
Name
PD21-12423
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).
Trial arms
Trial start
2023-03-20
Estimated PCD
2024-12-01
Trial end
2024-12-01
Status
Recruiting
Phase
Early phase I
Treatment
Ertugliflozin
Treatment with Ertugliflozin 5 mg oral once per day for one month
Arms:
Ertugliflozin then Placebo, Placebo
Placebo
Treatment with matching placebo to ertugliflozin administered orally once daily for a period of one month
Arms:
Ertugliflozin then Placebo, Placebo
Size
28
Primary endpoint
Change in the skin water content
Baseline and One month
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 28, 'type': 'ESTIMATED'}}
Updated at
2023-10-13
1 organization
2 products
2 indications
Organization
Icahn School of Medicine at Mount SinaiProduct
ErtugliflozinIndication
Upper respiratory congestionProduct
Placebo