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SGLT2 Inhibitor
Dapagliflozin for Heart Attack Recovery
Phase 2
Recruiting
Led By Jay Traverse, MD
Research Sponsored by Minneapolis Heart Institute Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with their first STEMI (> 18 years and < 75 years) who underwent successful primary PCI and able to give informed consent
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will test if dapagliflozin can improve heart function and reduce enlargement after a heart attack. Participants will take the medication or a placebo once daily for six months and have follow-up MRI tests and clinic visits.
Who is the study for?
This trial is for adults aged 18-75 who've had their first severe heart attack and received a procedure to open blocked arteries. They must have some heart muscle weakness and significant damage from the heart attack, but can't be on dialysis, pregnant, or have a life expectancy under one year. People with certain conditions like diabetes needing insulin or previous major heart issues aren't eligible.Check my eligibility
What is being tested?
The study tests if dapagliflozin improves heart function and reduces its enlargement after a heart attack compared to a placebo. Participants will take the medication daily for six months, undergo two cardiac MRI scans—one during hospitalization and another at six months—and receive follow-up calls.See study design
What are the potential side effects?
Dapagliflozin may cause urinary tract infections, dehydration leading to low blood pressure, yeast infections in women, increased cholesterol levels, kidney problems and rare cases of diabetic ketoacidosis even in those without diabetes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old, had a first heart attack, and underwent a successful procedure to open my heart's arteries.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in LVEDVI
Change in LVESVI
Secondary outcome measures
Change in LV mass
Change in LVEF
MACE rates - including hospitalization for CHF, repeat revascularization, MI and death and ICD implantation
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Treatment GroupActive Control1 Intervention
Treatment group will receive dapagliflozin in addition to standard heart attack medications for the duration of hospitalization and 6-month duration of the study.
Group II: Placebo GroupPlacebo Group1 Intervention
Placebo Group will receive placebo in addition to standard heart attack medications for the duration of hospitalization and 6-month duration of the study.
Find a Location
Who is running the clinical trial?
Minneapolis Heart Institute FoundationLead Sponsor
29 Previous Clinical Trials
15,385 Total Patients Enrolled
Jay Traverse, MDPrincipal InvestigatorMinneapolis Heart Institute Foundation
1 Previous Clinical Trials
41 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had heart bypass or valve surgery in the past.You are not expected to live for more than 1 year.You have a specific type of heart damage that is more than 10% of the size of the heart attack.I have had a major heart attack before.I am currently experiencing unresolved cardiogenic shock.My kidney function is very low or I am on dialysis.You have a condition that makes it unsafe for you to receive gadolinium.I am between 18 and 75 years old, had a first heart attack, and underwent a successful procedure to open my heart's arteries.You are not able to have a cardiac MRI for medical reasons.I have irregular heartbeats or repeated serious heart rhythm problems.I have type 1 diabetes or have had diabetic ketoacidosis.I have diabetes and use insulin.You had an allergic reaction to SGLT2 inhibitors before.I am currently taking SGLT2 inhibitors.You have a weak heart with a low ejection fraction (LVEF < 50%) as shown in heart tests.The size of the heart attack is more than 10% of the total mass of the left ventricle.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group
- Group 2: Placebo Group
Awards:
This trial has 0 awards, including: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.
Is the enrolment for this experiment restricted to adults aged 55 or below?
"Prospective participants must fall into the age range of 18-75 years old to qualify for this research trial."
Answered by AI
What potential perils are posed by Treatment Group to those who partake?
"After careful consideration, Treatment Group's safety rating was determined to be a 2 due to limited evidence supporting efficacy. However, there is some data that speaks in favor of the drug's security profile."
Answered by AI
Is this research accepting new participants at present?
"Affirmative. Per the data available on clinicaltrials.gov, this examination is actively recruiting as of August 4th 2022 after being initially posted on March 8th 2022. The trial requires 80 volunteers to be enrolled at a single medical site."
Answered by AI
What is the participant count of this research endeavor?
"Affirmative. According to clinicaltrials.gov, this medical study is recruiting patients right now; the initial posting was on August 3rd 2022 and a recent update occurred on August 4th 2022. 80 participants must be sourced from 1 site for successful completion of the trial."
Answered by AI
Who has the qualifications to join this experimental program?
"To participate in this medical trial, individuals must have experienced a myocardial infarction and be between 18 to 75 years of age. A total of 80 candidates are needed for the study."
Answered by AI
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