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Ertugliflozin for Heart Failure (ERTU-SODIUM Trial)
ERTU-SODIUM Trial Summary
This trial tests whether or not Ertugliflozin can help relieve congestion in the legs and improve blood flow.
ERTU-SODIUM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowERTU-SODIUM Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ERTU-SODIUM Trial Design
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Who is running the clinical trial?
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- I am on continuous heart-strengthening medications through an IV.My kidney function is very low.I have heart failure and experience mild to moderate symptoms.Your blood pressure is less than 90 mm Hg when the heart is pumping.I have had a heart transplant or a device implanted to help my heart pump.I am older than 18 years.I have had a heart attack or heart surgery in the last month.My health condition and treatments have been stable for the last month.I am using effective birth control if I am a woman who can become pregnant.Your heart's pumping ability is less than 40%.I have taken SGLT2 inhibitors in the past month.
- Group 1: Ertugliflozin then Placebo
- Group 2: Placebo
- 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.
Frequently Asked Questions
What is the projected participant count for this clinical experiment?
"Affirmative. As per the clinicaltrials.gov website, this medical investigation is currently recruiting patients and was initially posted on November 1st 2022. The most recent update occurred on November 3rd 2022, with 28 volunteers expected to be accepted from a single location."
Is this medication compliant with the Food and Drug Administration's regulations?
"The safety of this treatment has been rated a 3, since it is in Phase 4 trials and thus approved."
Are there still opportunities for new participants to join this research endeavor?
"Indeed, the information hosted on clinicaltrials.gov confirms that this medical research project is actively searching for participants. The trial was first listed on November 1st 2022 and has since been updated as of November 3rd 2022. 28 individuals have to be sourced from a single location"
Are there any previous investigations related to this treatment?
"Currently, 8 clinical trials are underway to examine the efficacy of this medical treatment. Of those studies, 4 are in Phase 3 and 221 different sites across the United States offer access to these tests. The most concentrated region for such research is Cleveland, Ohio."
Is this research project a groundbreaking discovery?
"Currently, 8 trials are ongoing involving the proposed medication. These clinical studies span 136 cities and 26 nations, with MSD Korea Ltd.'s 2019 Phase 3 drug approval trial being among the most noteworthy of these investigations having included 120 participants. In total, 18351 experiments have been conducted since that time."
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