Safety, Tolerability and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Part… (NCT03292653) | Clinical Trial Compass
TerminatedPhase 2
Safety, Tolerability and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Participants With Worsening Heart Failure
Stopped: 1st two cohorts provided the required data, therefore 3rd cohort was not deemed necessary
United States, Canada, Netherlands32 participantsStarted 2017-12-04
Plain-language summary
Primary Objectives:
* Assess the safety and tolerability of sotagliflozin in hemodynamically stable participants with worsening of heart failure, compared to placebo.
* Estimate the effects of sotagliflozin on plasma volume changes in hemodynamically stable participants with worsening of heart failure, compared to placebo.
Secondary Objectives:
* Explore the effect of sotagliflozin on erythropoiesis, as assessed by changes in plasma erythropoietin levels, in hemodynamically stable participants with worsening of heart failure, compared to placebo.
* Explore the effect of sotagliflozin on changes in plasma N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels, in hemodynamically stable participants with worsening of heart failure, compared to placebo.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Written informed consent.
* 18 years of age or older.
* Participants admitted to the hospital or had urgent visit to emergency department or heart failure unit/clinic or infusion center for Congestive Heart Failure (CHF), defined by:
* Presence of ≥2 of the following clinical signs and symptoms of congestion: jugular venous distension, pitting edema in lower extremities greater than trace, dyspnea, rales heard on auscultation, radiographic pulmonary congestion, weight gain above historical dry weight of at least 5 pounds (lbs) (2.27 Kilograms (kg)).
* Requiring treatment with intravenous (IV) diuretics.
* Estimated glomerular filtration rate (eGFR) ≥30 milliliter per minute (mL/min)/1.73 square meter (m\^2) at the screening or randomization visit by the 4 variable Modification of Diet in Renal Disease (MDRD) equation.
* Female participants must use a double contraception method during the study including a highly effective method of birth control, except if she has undergone sterilization at least 3 months earlier or is postmenopausal.
* Male participants, unless vasectomized and confirmed sterile by sperm analysis, must use condoms during the study and refrain from donating sperm up to 90 days after the day of last dose. If the participant has a female partner of childbearing potential, the participant must wear a condom and female partner must use at least 1 highly effective method of birth control during the study treatment period and the Follow-up p…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), AEs Leading to Discontinuation From the Investigational Medicinal Product (IMP) and Deaths
Timeframe: Baseline up to Day 14
2
Change From Baseline in Hemoconcentration as Assessed by Changes in Albumin to Day 14
Timeframe: Baseline to Day 14
3
Change From Baseline in Hemoconcentration as Assessed by Changes in Hematocrit to Day 14
Timeframe: Baseline to Day 14
4
Change From Baseline in Hemoconcentration as Assessed by Changes in Hemoglobin to Day 14
Timeframe: Baseline to Day 14
5
Change From Baseline in Hemoconcentration as Assessed by Changes in Total Protein to Day 14