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Sodium-glucose co-transporter 2 inhibitors
SGLT2 Inhibitors for Acute Decompensated Heart Failure
Phase 4
Waitlist Available
Led By Jonathan Grinstein, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 days
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial will study the effects of SGLT2i therapy on patients with acute decompensated heart failure who are admitted to the ICU.
Eligible Conditions
- Acute Heart Failure
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Indirect Fick Cardiac Index
Change in Pulmonary Capillary Wedge Pressure (PCWP)
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Group I: No SGLT2iActive Control1 Intervention
Participants will not be treated with a SGLT2i during their ICU stay. Heart failure care will be managed according to routine care, and data will be collected from the participant's medical record.
Group II: SGLT2iActive Control1 Intervention
Participants will be treated with a SGLT2i during their ICU stay. The SGLT2i and heart failure care will be managed according to routine care, and data will be collected from the participant's medical record.
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Who is running the clinical trial?
University of ChicagoLead Sponsor
1,054 Previous Clinical Trials
759,958 Total Patients Enrolled
12 Trials studying Heart Failure
1,501 Patients Enrolled for Heart Failure
Jonathan Grinstein, MDPrincipal InvestigatorUniversity of Chicago
1 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Heart Failure
20 Patients Enrolled for Heart Failure
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with type 1 diabetes.Your kidney function is very low, less than 30 milliliters per minute per square meter.Individuals who are Jehovah's WitnessesYou have been diagnosed with a specific type of high blood pressure in the lungs called group 1 pulmonary arterial hypertension.You need more insulin than the usual small amounts given when blood sugar is high.You have had a serious condition called diabetic ketoacidosis (DKA) in the past.You are allergic to SGLT2 inhibitor medications.You have had a bad reaction to SGLT2i medications in the past.You are waiting for a heart transplant or are currently using a heart-assisting device.You are older than 18 years.Your heart's pumping ability is reduced, with an ejection fraction of 40% or less.Your kidney function (eGFR) is above 30 ml/minute/1.73 m2.You are in the hospital's critical care unit for severe heart failure and need continuous monitoring with a special catheter.
Research Study Groups:
This trial has the following groups:- Group 1: No SGLT2i
- Group 2: SGLT2i
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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