Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05562063
Other study ID # GCO-22-0574
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date October 26, 2022
Est. completion date November 2025

Study information

Verified date May 2024
Source Icahn School of Medicine at Mount Sinai
Contact Juan J Badimon
Phone (212) 241-8484
Email Juan.Badimon@mssm.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date November 2025
Est. primary completion date November 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: patients should meet all of the following 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 Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sotagliflozin
Daily administration of sotagliflozin (2x200 mg, PO, OD) for 6 months.
Placebo
Matching placebo for 6 months.

Locations

Country Name City State
United States Icahn School of Medicine at Mount Sinai New York New York

Sponsors (1)

Lead Sponsor Collaborator
Juan Badimon

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Left Ventricular mass in CMRI Changes in Left Ventricular (LV) mass at 6 months compared to baseline Baseline and 6 months
Secondary Changes in Left Ventricular end-systolic volume Changes in left ventricular end-systolic volume (LVESV) in CMRI at 6 months compared to baseline Baseline and 6 months
Secondary Changes in Left Ventricular end-diastolic volume Changes in left ventricular end-diastolic volume (LVEDV) in CMRI at 6 months compared to baseline Baseline and 6 months
Secondary Changes in extracellular volume (ECV) Changes in extracellular volume (ECV) to assess Left Ventricular interstitial myocardial fibrosis as quantified using T1 mapping at 6 months compared to baseline Baseline and 6 months
Secondary Changes in Left atrial volume index Changes in Left atrial volume index measured by CMRI at 6 months compared to baseline Baseline and 6 months
Secondary Changes in Peak oxygen consumption (peakVO2) Changes in exercise capacity as assessed by peak oxygen consumption in Cardiopulmonary exercise test (CPET) at 6 months compared to baseline Baseline and 6 months
Secondary Changes 6 minute walk test Changes in exercise tolerance as assessed by 6 minute walk test, or the distance covered over a time of 6 minutes, at 6 months compared to baseline Baseline and 6 months
Secondary Changes in The Kansas City Cardiomyopathy Questionnaire (KCCQ) Changes in The KCCQ at 6 months compared to baseline. The KCCQ is the most widely used instrument to evaluate quality of life in Heart Failure (HF).
The KCCQ is a 12-item self-administered questionnaire used to measure the patient's perception of their health status. The KCCQ is a disease-specific health status instrument composed of 12 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Full scale range is from 0 to 100; higher scores reflect better health status.
Baseline and 6 months
See also
  Status Clinical Trial Phase
Suspended NCT05839730 - Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction N/A
Recruiting NCT05095688 - Relationship Between Adipose Tissue Distribution and Arterial Stiffness in HFpEF
Recruiting NCT06379152 - Effect of Bilirubin on Prognosis in Heart Failure With Preserved Ejection Fraction
Recruiting NCT05676684 - Dapagliflozin, Spironolactone or Both for HFpEF Phase 2/Phase 3
Recruiting NCT04153136 - Effects of Sacubitril/Valsartan on Subclinical Heart Failure in HIV (The ENCHANTMENT HIV Study) Phase 2
Recruiting NCT05715697 - Renal Denervation in Patients With Chronic Heart Failure With Preserved Ejection Fraction N/A
Recruiting NCT06114498 - Hospital Register of Decompensated Heart Failure With Preserved Ejection Fraction
Recruiting NCT04745013 - PeRsonalIzed remOtely Guided Preventive exeRcIse Therapy for a healThY Heart N/A
Completed NCT05126836 - Cilostazol for HFpEF Phase 2
Completed NCT05586828 - A Single-center Retrospective Cohort Study to Explore the Prognostic Significance of CONUT in Elderly CAD Patients With HFpEFand Compare CONUT With Other Objective Nutritional Indices.
Recruiting NCT04594499 - The Relationship Between Pericardial Fat Thickness and Arterial Stiffness in HFpEF Patients
Active, not recruiting NCT05204238 - Follow Up of acuTe Heart failUre: a pRospective Echocardiographic and Clinical Study (FUTURE)
Completed NCT04535726 - The Relationship Between Blood Pressure and Arterial Stiffness in HFpEF Patients With Different Levels of Obesity
Recruiting NCT03550235 - Exploration of Dyspnea at Non-high Brain Natriuretic Peptide (BNP)
Completed NCT04633460 - Acute Effects of Exogenous Ketone Ester Administration in Heart Failure Phase 2
Completed NCT06228807 - Clinical Characteristics and Predictors of Adverse Outcomes in HFpEF
Active, not recruiting NCT05284617 - Exploratory Ph 2A, Double-Blind, Placebo-Controlled Dose Escalation Study of Safety, Tolerability, PD, & PK of HU6 for Subjects With Obese HFpEF Phase 2
Recruiting NCT06027307 - Enavogliflozin Outcome Trial in Functional Tricuspid Regurgitation Phase 3
Withdrawn NCT05322616 - Single-Ascending Dose Study of JK07 in Subjects With HFpEF Phase 1
Not yet recruiting NCT06309537 - Chemoreflex Sensitivity in HFpEF