Outcome-targeted Therapy: Principle and Outcome Evaluation: Clinical Study and Phenotype-genotype Correlation

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Oct 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called simvastatin on children and adults with dilated cardiomyopathy (DCM), a condition where the heart becomes enlarged and cannot pump blood effectively. The researchers believe that simvastatin may help improve heart function in patients who are not responding well to other treatments. They are looking for individuals diagnosed with DCM who are experiencing significant heart function issues, particularly those with a specific heart measurement (left ventricular ejection fraction) that indicates poor heart performance, and who have not seen improvement after using other heart medications.

To participate in the study, patients must be diagnosed with DCM and meet certain criteria, such as having low heart function despite being on heart medications for at least three months. The trial is open to people of all ages and genders, and participants will need to give their consent before joining. If eligible, those who take part can expect to receive simvastatin and be monitored for any changes in their heart function. It's important to note that individuals with certain medical conditions or previous heart surgeries may not be able to join the trial. Overall, this study aims to explore a potential new treatment option for those struggling with this challenging heart condition.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• Patients diagnosed as dilated cardiomyopathy, classified as NYHA functional class II or III and still have a low left ventricular ejection fraction (LVEF) (LVEF \< 45% and the Z score of the LV end-diastolic diameter \> 2.0) will be enrolled, if they have normal or high level of cholesterol and triglyceride and fulfill any of the following criteria:
• • 1. Patients who have already received anti-congestive medications for at least three months and still have poor LV function (LVEF \< 45% and the Z score of the LV end-diastolic diameter \> 2.0).
• • 2. Patients who have persistent or even worsening heart failure after one month of anti-congestive medications.
• • 3. Patients who have positive family history of dilated cardiomyopathy and have received anti-congestive medications for one month.
• • 4. Patients or their parents must sign an informed consent form.
• • Exclusion criteria
• Patients who fulfill any of the following criteria will be excluded from the trial:
• • 1. Patients who underwent prior cardiac surgery. Those who received DCM related surgery, such as mitral valve plasy, for longer than a year are not subject to this restriction.
• • 2. Patients who had active liver / renal dysfunction.
• • 3. Concomitant use with gemfibrozil, cyclosporine, danazol, strong CYP3A4 inhibitors (eg, boceprevir, clarithromycin, erythromycin, HIV protease inhibitors, itraconazole, ketoconazole, nefazodone, posaconazole, telaprevir, telithromycin, voriconazole), or cobicistat-containing products
• • 4. Patients who are pregnant or plan to pregnancy in the period of study.
• • 5. Patients who are intolerance to simvastatin therapy.