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

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ClinicalTrials.gov Identifier: NCT05562063
Recruitment Status : Recruiting
First Posted : September 30, 2022
Last Update Posted : May 9, 2024
Sponsor:
Information provided by (Responsible Party):
Juan Badimon, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE September 27, 2022
First Posted Date  ICMJE September 30, 2022
Last Update Posted Date May 9, 2024
Actual Study Start Date  ICMJE October 26, 2022
Estimated Primary Completion Date November 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2022)		 Changes in Left Ventricular mass in CMRI [ Time Frame: Baseline and 6 months ]
Changes in Left Ventricular (LV) mass at 6 months compared to baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2022)
  • Changes in Left Ventricular end-systolic volume [ Time Frame: Baseline and 6 months ]
    Changes in left ventricular end-systolic volume (LVESV) in CMRI at 6 months compared to baseline
  • Changes in Left Ventricular end-diastolic volume [ Time Frame: Baseline and 6 months ]
    Changes in left ventricular end-diastolic volume (LVEDV) in CMRI at 6 months compared to baseline
  • Changes in extracellular volume (ECV) [ Time Frame: Baseline and 6 months ]
    Changes in extracellular volume (ECV) to assess Left Ventricular interstitial myocardial fibrosis as quantified using T1 mapping at 6 months compared to baseline
  • Changes in Left atrial volume index [ Time Frame: Baseline and 6 months ]
    Changes in Left atrial volume index measured by CMRI at 6 months compared to baseline
  • Changes in Peak oxygen consumption (peakVO2) [ Time Frame: Baseline and 6 months ]
    Changes in exercise capacity as assessed by peak oxygen consumption in Cardiopulmonary exercise test (CPET) at 6 months compared to baseline
  • Changes 6 minute walk test [ Time Frame: Baseline and 6 months ]
    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
  • Changes in The Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Baseline and 6 months ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients
Official Title  ICMJE SOTA-P-CARDIA Trial: A Randomized Trial of Sotagliflozin in HFpEF Patients Without Diabetes
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure With Preserved Ejection Fraction
Intervention  ICMJE
  • Drug: Sotagliflozin
    Daily administration of sotagliflozin (2x200 mg, PO, OD) for 6 months.
  • Drug: Placebo
    Matching placebo for 6 months.
Study Arms  ICMJE
  • Experimental: Sotagliflozin
    Daily administration of sotagliflozin (2x200 mg, orally, once a day) for 6 months.
    Intervention: Drug: Sotagliflozin
  • Placebo Comparator: Placebo
    Daily administration of placebo (2 tablet identical in appearance and color to sotagliflozin tablets, orally, once a day) for 6 months.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 8, 2024)		 60
Original Estimated Enrollment  ICMJE
 (submitted: September 27, 2022)		 100
Estimated Study Completion Date  ICMJE November 2025
Estimated Primary Completion Date November 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Juan J Badimon (212) 241-8484 Juan.Badimon@mssm.edu
Contact: Carlos G Santos-Gallego, MD 212-241-8484 carlos.santos-gallego@mssm.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05562063
Other Study ID Numbers  ICMJE GCO-22-0574
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Undecided: It is not yet known if there will be a plan to make IPD available.
Current Responsible Party Juan Badimon, Icahn School of Medicine at Mount Sinai
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Juan Badimon
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Juan J Badimon Icahn School of Medicine at Mount Sinai
Principal Investigator: Carlos G Santos-Gallego, MD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP