Back to resultsSotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients
Primary Purpose
Heart Failure With Preserved Ejection Fraction
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sotagliflozin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure With Preserved Ejection Fraction
Eligibility Criteria
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.
Sites / Locations
- Icahn School of Medicine at Mount SinaiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sotagliflozin
Placebo
Arm Description
Daily administration of sotagliflozin (2x200 mg, orally, once a day) for 6 months.
Daily administration of placebo (2 tablet identical in appearance and color to sotagliflozin tablets, orally, once a day) for 6 months.
Outcomes
Primary Outcome Measures
Changes in Left Ventricular mass in CMRI
Changes in Left Ventricular (LV) mass at 6 months compared to baseline
Secondary Outcome Measures
Changes in Left Ventricular end-systolic volume
Changes in left ventricular end-systolic volume (LVESV) in CMRI at 6 months compared to baseline
Changes in Left Ventricular end-diastolic volume
Changes in left ventricular end-diastolic volume (LVEDV) in CMRI at 6 months compared to baseline
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
Changes in Left atrial volume index
Changes in Left atrial volume index measured by CMRI at 6 months compared to baseline
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05562063
Brief Title
Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients
Official Title
SOTA-P-CARDIA Trial: A Randomized Trial of Sotagliflozin in HFpEF Patients Without Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Juan Badimon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Preserved Ejection Fraction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sotagliflozin
Arm Type
Experimental
Arm Description
Daily administration of sotagliflozin (2x200 mg, orally, once a day) for 6 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Daily administration of placebo (2 tablet identical in appearance and color to sotagliflozin tablets, orally, once a day) for 6 months.
Intervention Type
Drug
Intervention Name(s)
Sotagliflozin
Intervention Description
Daily administration of sotagliflozin (2x200 mg, PO, OD) for 6 months.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo for 6 months.
Primary Outcome Measure Information:
Title
Changes in Left Ventricular mass in CMRI
Description
Changes in Left Ventricular (LV) mass at 6 months compared to baseline
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Changes in Left Ventricular end-systolic volume
Description
Changes in left ventricular end-systolic volume (LVESV) in CMRI at 6 months compared to baseline
Time Frame
Baseline and 6 months
Title
Changes in Left Ventricular end-diastolic volume
Description
Changes in left ventricular end-diastolic volume (LVEDV) in CMRI at 6 months compared to baseline
Time Frame
Baseline and 6 months
Title
Changes in extracellular volume (ECV)
Description
Changes in extracellular volume (ECV) to assess Left Ventricular interstitial myocardial fibrosis as quantified using T1 mapping at 6 months compared to baseline
Time Frame
Baseline and 6 months
Title
Changes in Left atrial volume index
Description
Changes in Left atrial volume index measured by CMRI at 6 months compared to baseline
Time Frame
Baseline and 6 months
Title
Changes in Peak oxygen consumption (peakVO2)
Description
Changes in exercise capacity as assessed by peak oxygen consumption in Cardiopulmonary exercise test (CPET) at 6 months compared to baseline
Time Frame
Baseline and 6 months
Title
Changes 6 minute walk test
Description
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
Time Frame
Baseline and 6 months
Title
Changes in The Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
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.
Time Frame
Baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan J Badimon
Phone
(212) 241-8484
Email
Juan.Badimon@mssm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos G Santos-Gallego, MD
Phone
212-241-8484
Email
carlos.santos-gallego@mssm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan J Badimon
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlos G Santos-Gallego, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Undecided: It is not yet known if there will be a plan to make IPD available.
Learn more about this trial
Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients
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