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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
Age > 18 years old
Admitted to CCU by advanced heart failure service for decompensated heart failure requiring continuous hemodynamic monitoring with a pulmonary artery catheter
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 days
Awards & highlights
Study 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
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are older than 18 years.
Select...
You are in the hospital's critical care unit for severe heart failure and need continuous monitoring with a special catheter.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Indirect Fick Cardiac Index
Change in Pulmonary Capillary Wedge Pressure (PCWP)
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
1,003 Previous Clinical Trials
819,748 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
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any additional participants being enrolled in this experiment?
"As demonstrated on clinicaltrials.gov, this particular medical trial is not currently enrolling any patients. Initially posted on January 1st 2023 and most recently updated November 23rd 2022, the study does not have an open recruitment process. However, there are 703 ongoing studies that may welcome participation from individuals seeking treatment for their condition."
Answered by AI
Has the Federal Drug Administration validated No SGLT2i?
"With the treatment being approved, No SGLT2i was given a score of 3 on our safety scale from 1 to 3."
Answered by AI
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