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Metformin + Lifestyle Changes for Atrial Fibrillation (TRIM-AF Trial)
TRIM-AF Trial Summary
This trial is testing whether metformin and lifestyle/risk factor modification can help prevent atrial fibrillation in people with pacemakers or defibrillators.
TRIM-AF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTRIM-AF Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TRIM-AF Trial Design
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Who is running the clinical trial?
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- I am not pregnant, breastfeeding, or if capable of childbearing, I am willing to use contraception.You have a pacemaker or ICD with certain features for monitoring heart function.You have not had atrial fibrillation recorded on your heart monitoring device in the past 6 months.I have permanent atrial fibrillation and no plans to change it.You drink more than two alcoholic drinks on average every day.My current episode of atrial fibrillation has lasted more than 12 months.I am taking medication for diabetes.I am not taking any anti-retroviral protease inhibitors or topiramate.My kidney function is reduced (eGFR <45).I am scheduled for a heart rhythm treatment or surgery within the first 3 months of the study.I am willing and able to follow the study's treatment, diet, exercise plans, and attend all follow-up visits.I have irregular heartbeats and plans to normalize it.I have never had atrial fibrillation.You have a permanent pacemaker or an implantable cardioverter-defibrillator with certain features.I am under 18 years old.My bilirubin levels are high, but it's due to Gilbert's syndrome.I have severe heart failure.I am 18 years old or older.I have been on the same heart rhythm medication for the last 3 months.I had a procedure to correct my heart rhythm within the last 6 months.You have had at least one episode of atrial fibrillation (AF) lasting 5 minutes or longer in the past 3 months, as detected by a cardiac implantable electrical device.You have another health condition that is expected to significantly shorten your life.You are allergic to metformin.My heart's electrical activity measurements meet specific criteria due to my pacemaker and medication.
- Group 1: Lifestyle/Risk Factor Modification
- Group 2: Metformin
- Group 3: Control
- Group 4: No Atrial Fibrillation
- Group 5: Metformin + LRFM
- 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.
- 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
Are there any recruitment opportunities for this clinical research?
"According to the clinical trial registry, this study is presently recruiting participants. The posting date for this research was August 24th 2018 and it has been updated as recently as December 4th 2021."
For what health concerns is Lifestyle/Risk Factor Modification most often deployed?
"The therapeutic lifestyle/risk factor modification has a range of applications, notably treating exercise and the conditions type 1 diabetes mellitus, diabetic ketoacidosis, polycystic ovary syndrome."
To what extent is Lifestyle/Risk Factor Modification beneficial for patients?
"This Phase 4 trial has generated enough evidence for the safety of Lifestyle/Risk Factor Modification to be rated as a 3 on Power's scale."
Have past research efforts explored the impact of Lifestyle/Risk Factor Modification?
"Currently, 170 ongoing clinical trials are researching the effects of Lifestyle/Risk Factor Modification with 43 of them in their final stage. Pittsburgh Pennsylvania is just one out of 1903 sites that have approved trials regarding this subject."
How many participants are involved in this clinical trial?
"Affirmative. The listing on clinicaltrials.gov reveals that this research is presently recruiting participants, which was first posted on August 24th 2018 and updated on December 4th 2021. 270 individuals are needed to be enrolled from a single medical facility."
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