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Ertugliflozin for Diabetes & Heart Failure (EMMED-HF Trial)
EMMED-HF Trial Summary
This trial will see if a SGLTi2 inhibitor alters cardiac metabolism in people with HFpEF and DM2 compared to placebo.
- Type 2 Diabetes
- Heart Failure
EMMED-HF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowEMMED-HF Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2017 Phase 3 trial • 621 Patients • NCT02033889EMMED-HF Trial Design
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- You have heart failure due to poorly controlled high blood pressure or heart muscle damage from reduced blood flow.You cannot have an MRI if you have metal implants or are very claustrophobic. You cannot do treadmill exercise if you have an amputated limb, severe osteoarthritis, or other major physical limitations.You are expected to change your heart failure medication during the study.You have had a heart attack, stroke, or severe blood vessel blockage in the last 6 months, or you have had heart or blood vessel surgery in the last 3 months.You have a very serious illness that could be life-threatening or are not expected to live for more than 6 months.You have low levels of red blood cells (Hgb) or platelets in your blood.You have a condition where your heart doesn't pump blood effectively (left ventricular ejection fraction less than 50%).You have a history of insulin resistance or type 2 diabetes and are taking certain diabetes medications, but not SGLT2 inhibitors, and your HgbA1c level is between 5.8% and 10.5%.Your heart's pumping ability, measured in a recent test, is more than 50%.You haven't been hospitalized for heart failure in the last 6 months.You have been hospitalized for heart failure with preserved ejection fraction (HFpEF) in the past 6 months.You have severe kidney disease with very low kidney function.You are between 18 and 75 years old.You are too heavy for your height, with a body mass index (BMI) between 29 and 42.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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.
- Group 1: Placebo
- Group 2: Ertugliflozin Treatment Arm
Frequently Asked Questions
Does this scientific investigation include persons aged 55 or greater?
"Applicants aged between 18 and 75 are eligible to participate in this medical trial. Those younger than 18 have 215 other studies to choose from, while those over 65 can pick from 1,742 different clinical trials."
How many participants are currently being recruited for this testing program?
"That is correct. According to the data hosted on clinicaltrials.gov, this medical trial which first began recruiting patients on March 1st 2020, is still actively searching for 52 participants at a single site."
Are there existing vacancies for participants in this research study?
"That is correct. Clinicaltrials.gov records indicate that this trial, which kicked off on March 1st 2020, is still searching for participants. The study requires 52 individuals to be registered from a single site."
Has the Food & Drug Administration sanctioned Ertugliflozin 5 mg?
"The safety of Ertugliflozin 5 mg scored a 3 in our assessment due to the Phase 4 trial status, which implies that this treatment has already been approved."
Does this experiment constitute a pioneering venture?
"Research on Ertugliflozin 5 mg began in 2019 when MSD Korea Ltd. sponsored the initial 120-person trial. The drug subsequently received its Phase 3 approval and, presently, 8 trials for it are going on across 26 countries and 136 cities."
Is it possible for me to participate in this research protocol?
"Eligibility for this medical research is limited to those aged 18-75 with a diagnosis of type 2 diabetes mellitus. The team are hoping to register 52 people in total."
To what extent have researchers explored Ertugliflozin 5 mg's feasibility in clinical settings?
"Currently, there are 8 clinical trials researching Ertugliflozin 5 mg with 4 of them being in phase 3. In total, 221 sites across the United States have been identified as running studies for this medication, though Cleveland has a particularly high concentration of research centres."
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