COMPLETED

Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients

Conditions

Heart Failure With Preserved Ejection Fraction

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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 clinical benefits of the dual Sodium-Glucose cotransporter (SGLT) 1 and 2-inhibition have recently been reported in two clinical trials. The SOLOIST reported the benefits of sotagliflozin in Type-2 Diabetes Mellitus (T2DM) patients hospitalized for worsening of Heart Failure (HF), while the SCORED involved T2DM patients with Chronic Kidney Disease (CKD). It is worth noting that not only did the event curves separate within the first week post-treatment, but the effects of sotagliflozin on HF-related outcomes were observed regardless of Left Ventricular Ejection Fraction (LVEF) values and did not seem to attenuate with increasing LVEF as seen with empagliflozin and sacubitril/valsartan. Despite the favorable outcomes, the mechanism(s) of action through which sotagliflozin exerts these benefits remains unclear. The present study aims to investigate the potential (non-glucose dependent) "cardio-renal" pleiotropic effects of sotagliflozin in a mechanistic, randomized, double blind, placebo-control trial in HF patients with preserved ejection fraction (HFpEF). Comparisons between treatment groups will be made using cardiac MRI, CPET, 6-MWT and KCCQ-12.

Official Title

SOTA-P-CARDIA Trial: A Randomized Trial of Sotagliflozin in HFpEF Patients Without Diabetes

Quick Facts

Study Start:2022-10-26

Study Completion:2025-06-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05562063

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 Criteria	Exclusion Criteria
* Ambulatory patients age ≥ 18 years * Written informed consent prior to admission to the trial. * No diabetes as confirmed by HbA1c \<6.5%, fasting serum glucose \<126 mg/dL, and review of concomitant medications and medical history * Diagnosis of Heart failure (NYHA II to III) * LVEF \> 50% * On medical therapy for heart failure consistent with prevailing cardiovascular guidelines at a stable dose for ≥4 weeks prior to screening, except for diuretics which must have been stable for ≥2 weeks prior to screening * Women of child-bearing potential must agree to use birth control measures with a failure rate of \<1% per year during the treatment period of the study	* Type 1 and Type 2 diabetes * Acute coronary syndrome (ACS) or cardiac surgery within the last week. * Pregnant or lactating women, * Acute decompensated HF or hospitalized for HF within 1 month from screening visit * Glomerular Filtration Rate (GFR) \< 25 ml/ min/1.73m2, * Patients on drugs with potential interaction with sotagliflozin including digoxin, phenytoin, HIV medication and rifampin. * Receiving SGLT2-I 3-months prior to randomization. * non-MRI compatible PM or ICD and any other medical or physical condition considered unappropriated by a study physician.

Inclusion Criteria

Exclusion Criteria

* Ambulatory patients age ≥ 18 years
* Written informed consent prior to admission to the trial.
* No diabetes as confirmed by HbA1c \<6.5%, fasting serum glucose \<126 mg/dL, and review of concomitant medications and medical history
* Diagnosis of Heart failure (NYHA II to III)
* LVEF \> 50%
* On medical therapy for heart failure consistent with prevailing cardiovascular guidelines at a stable dose for ≥4 weeks prior to screening, except for diuretics which must have been stable for ≥2 weeks prior to screening
* Women of child-bearing potential must agree to use birth control measures with a failure rate of \<1% per year during the treatment period of the study

* Type 1 and Type 2 diabetes
* Acute coronary syndrome (ACS) or cardiac surgery within the last week.
* Pregnant or lactating women,
* Acute decompensated HF or hospitalized for HF within 1 month from screening visit
* Glomerular Filtration Rate (GFR) \< 25 ml/ min/1.73m2,
* Patients on drugs with potential interaction with sotagliflozin including digoxin, phenytoin, HIV medication and rifampin.
* Receiving SGLT2-I 3-months prior to randomization.
* non-MRI compatible PM or ICD and any other medical or physical condition considered unappropriated by a study physician.

Contacts and Locations

Principal Investigator

Juan J Badimon

PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Carlos G Santos-Gallego, MD

PRINCIPAL_INVESTIGATOR

Icahn 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: Juan Badimon

Juan J Badimon, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai
Carlos G Santos-Gallego, MD, PRINCIPAL_INVESTIGATOR, Icahn 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 Date2022-10-26

Study Completion Date2025-06-04

Study Record Updates

Study Start Date2022-10-26

Study Completion Date2025-06-04

Terms related to this study

Additional Relevant MeSH Terms

Heart Failure With Preserved Ejection Fraction