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SGLT-1 and SGLT-2 Inhibitor

Sotagliflozin for Heart Failure

Phase 4
Recruiting
Led By Carlos G Santos-Gallego, MD
Research Sponsored by Juan Badimon
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
LVEF > 50%
No diabetes as confirmed by HbA1c <6.5%, fasting serum glucose <126 mg/dL, and review of concomitant medications and medical history
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 months
Awards & highlights

Study Summary

This trial looks at how a drug, sotagliflozin, could help people with heart failure and kidney disease, and will measure its effects using MRI, CPET, 6-MWT and KCCQ-12.

Who is the study for?
This trial is for adults over 18 with heart failure who have a normal ejection fraction (LVEF > 50%) and are not diabetic. They must be on stable heart failure medication, except diuretics which need to be stable for at least two weeks. Women able to have children must use effective birth control during the study.Check my eligibility
What is being tested?
The trial is testing Sotagliflozin, a drug that may help heart failure patients without affecting blood sugar levels. It's compared against a placebo in a double-blind setup where neither doctors nor patients know who gets the real medicine. Effects will be checked using heart scans and physical tests.See study design
What are the potential side effects?
Sotagliflozin can potentially interact with certain medications like digoxin or HIV drugs and might not be safe for those with severe kidney issues or incompatible medical devices like some pacemakers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart's pumping ability is normal.
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I do not have diabetes, as shown by my blood tests and medical history.
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I have been diagnosed with moderate to moderately severe heart failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Left Ventricular mass in CMRI
Secondary outcome measures
Changes 6 minute walk test
Changes in Left Ventricular end-diastolic volume
Changes in Left Ventricular end-systolic volume
+4 more

Side effects data

From 2019 Phase 3 trial • 277 Patients • NCT03242018
11%
Glomerular filtration rate decreased
11%
Urinary tract infection
10%
Hyperkalaemia
10%
Vitamin D deficiency
9%
Nasopharyngitis
5%
Influenza
5%
Diarrhoea
5%
Renal impairment
3%
Arthralgia
2%
End stage renal disease
2%
Renal failure
2%
Hyperuricaemia
2%
Hypoglycaemia
1%
Femoral neck fracture
1%
Acute myocardial infarction
1%
Acute respiratory failure
1%
Atrial fibrillation
1%
Pancreatic carcinoma
1%
Pulmonary hypertension
1%
Peripheral ischaemia
1%
Acute kidney injury
1%
Hypertension
1%
Asthenia
1%
Renal colic
1%
Inguinal hernia
1%
Plasma cell myeloma
1%
Post procedural haemorrhage
1%
Peripheral sensorimotor neuropathy
1%
Atrioventricular block complete
1%
Cardiac failure
1%
Obstructive pancreatitis
1%
Cholangitis
1%
Metatarsalgia
1%
Cholelithiasis
1%
Cellulitis
1%
Gangrene
1%
Osteomyelitis
1%
Cardiac failure chronic
1%
Pneumonia bacterial
1%
Bronchitis
1%
Alanine aminotransferase increased
1%
Haemorrhoids
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Sotagliflozin 200 mg
Sotagliflozin 400 mg

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SotagliflozinExperimental Treatment1 Intervention
Daily administration of sotagliflozin (2x200 mg, orally, once a day) for 6 months.
Group II: PlaceboPlacebo Group1 Intervention
Daily administration of placebo (2 tablet identical in appearance and color to sotagliflozin tablets, orally, once a day) for 6 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sotagliflozin
2013
Completed Phase 3
~5700

Find a Location

Who is running the clinical trial?

Juan BadimonLead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
Carlos G Santos-Gallego, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
28 Total Patients Enrolled
1 Trials studying Heart Failure
28 Patients Enrolled for Heart Failure
Juan J BadimonPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Media Library

Sotagliflozin (SGLT-1 and SGLT-2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05562063 — Phase 4
Heart Failure Research Study Groups: Sotagliflozin, Placebo
Heart Failure Clinical Trial 2023: Sotagliflozin Highlights & Side Effects. Trial Name: NCT05562063 — Phase 4
Sotagliflozin (SGLT-1 and SGLT-2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05562063 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are current participants of this investigation?

"Affirmative. According to clinicaltrials.gov, this medical investigation is actively seeking participants after being posted on October 26th 2022 and last updated November 17th of the same year. Currently 100 patients are enrolled from a single site."

Answered by AI

Are individuals currently eligible to take part in this experiment?

"Data hosted on clinicaltrials.gov exhibits that this trial is actively searching for participants, with the initial posting occurring on October 26th 2022 and a recent edit taking place on November 17th of the same year."

Answered by AI

To what extent does Sotagliflozin present a risk to individuals?

"The safety level of Sotagliflozin is adjudged to be a 3, as it has already been approved for use during Phase 4 trials."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients
Juan Badimon 2022. "Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05562063.
~5 spots leftby Jun 2024
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