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New treatment option for Dilated Cardiomyopathy
Official title Outcome-targeted Therapy: Principle and Outcome Evaluation: Clinical Study and Phenotype-genotype Correlation
ClinicalTrials.gov ID: NCT06632834
What this study is testing
What is simvastatin therapy?
simvastatin therapy is an investigational medicine, given as an once-daily, being studied as a potential treatment for dilated cardiomyopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Brief Summary(Use lay language. Include a statement of the study hypothesis.): Dilated cardiomyopathy (DCM) is the most common childhood cardiomyopathy and is associated with significant early morbidity and mortality.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 99
You may be able to join if
- Patients diagnosed as dilated cardiomyopathy, classified as NYHA functional class II or III and still have a low left ventricular ejection fraction...
- Patients who have already received anti-congestive medications for at least three months and still have poor LV function (LVEF \ 2.0).
- Patients who have persistent or even worsening heart failure after one month of anti-congestive medications.
- Patients who have positive family history of dilated cardiomyopathy and have received anti-congestive medications for one month.
- Patients or their parents must sign an informed consent form.
You likely can't join if
- Patients who fulfill any of the following criteria will be excluded from the trial:
- Patients who underwent prior cardiac surgery. Those who received DCM related surgery, such as mitral valve plasy, for longer than a year are not...
- Patients who had active liver / renal dysfunction.
- Concomitant use with gemfibrozil, cyclosporine, danazol, strong CYP3A4 inhibitors (eg, boceprevir, clarithromycin, erythromycin, HIV protease...
- Patients who are pregnant or plan to pregnancy in the period of study.
- Patients who are intolerance to simvastatin therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Taipei County, Zhongzheng District, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei County, Zhongzheng District, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.