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Trial record 21 of 157 for:    Idiopathic Dilated Cardiomyopathy

Simvastatin Therapy in Patients With Dilated Cardiomyopathy. (SavDCM)

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ClinicalTrials.gov Identifier: NCT03775070
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
Dilated cardiomyopathy (DCM) is the most common childhood cardiomyopathy and is associated with significant early morbidity and mortality. About half of patients die or require heart transplantation within 5 years of diagnosis. The medical therapy for DCM with heart failure includes anti-congestive medications and antiplatelet therapy. Those who fail to improve within the first year of diagnosis usually deteriorated even upon aggressive anti-congestive medications. The investigators had conducted precision-medicine-based approach to provide strategic approach as drug repurposing to identify new treatments. The investigators have identified the beneficial effects from a statin, simvastatin, to restore the cardiac contractility. The investigators would further assess the efficacy of simvastatin to improve the cardiac function in patients with DCM.

Condition or disease Intervention/treatment Phase
Dilated Cardiomyopathy Drug: Simvastatin Phase 2

Detailed Description:

Dilated cardiomyopathy (DCM) is the most common childhood cardiomyopathy and is associated with significant early morbidity and mortality. About half of patients die or require heart transplantation within 5 years of diagnosis. The survival advantage from transplantation is limited, particularly in DCM infants.

The medical therapy for DCM with heart failure includes anti-congestive medications and antiplatelet therapy. Those who fail to improve within the first year of diagnosis usually deteriorated even upon aggressive anti-congestive medications. The investigators had conducted precision-medicine-based approach to provide strategic approach as drug repurposing to identify new treatments. The investigators have identified the beneficial effects from a statin, simvastatin, to restore the cardiac contractility in a DCM proband.The initial experience in the proband is promising.

Simvastatin is effective in lowing LDL and cholesterol, thereby to improve the outcome of patients with coronary arterial disease, familiar hypercholesterolemia, etc. For children, though the dosage range and the indication remain unclear, it had been used in children with various diseases. Simvastatin had been given in a small cohort of adult DCM. Patients treated with simvastatin had a lower New York Heart Association functional class compared with those receiving placebo. The LVEF also improved in the simvastatin group. The investigators would further assess the efficacy of simvastatin to improve the cardiac function in patients with DCM.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Single-armed, Exploratory Study of Simvastatin Therapy on the Cardiac Function in Patients With Dilated Cardiomyopathy.
Actual Study Start Date : December 31, 2018
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021


Arm Intervention/treatment
Experimental: Simvastatin
Simvastatin, 0.5mg/kg/d(maximum 20mg), once daily
Drug: Simvastatin
  • Starting dosage: in adult, the dose of simvastatin is 10 mg once daily. In children, the dose is 0.25mg/Kg/day (maximum dose: 10 mg/d).
  • Target dosage: in adult, the dose of simvastatin is 20 mg once daily. In children, the dose is 0.5mg/Kg/day (maximum dose: 20 mg/d).
  • The basic anti-congestive medication will be kept as the same.




Primary Outcome Measures :
  1. Change from base line in left ventricular ejection fraction and end-diastolic dimention by cardiac ultrasound. [ Time Frame: baseline, 1st week ]
  2. Change from base line in left ventricular ejection fraction and end-diastolic dimention by cardiac ultrasound. [ Time Frame: baseline, 1st month ]
  3. Change from base line in left ventricular ejection fraction and end-diastolic dimention by cardiac ultrasound. [ Time Frame: baseline, 3rd month ]
  4. Change from base line in left ventricular ejection fraction and end-diastolic dimention by cardiac ultrasound. [ Time Frame: baseline, 6th month ]
  5. Change from base line in left ventricular ejection fraction and end-diastolic dimention by cardiac ultrasound. [ Time Frame: baseline, 9th month ]
  6. Change from base line in left ventricular ejection fraction and end-diastolic dimention by cardiac ultrasound. [ Time Frame: baseline, 12th month ]
  7. Change from base line in left ventricular ejection fraction and end-diastolic dimention by cardiac ultrasound. [ Time Frame: baseline, 15th month ]
  8. Change from base line in left ventricular ejection fraction and end-diastolic dimention by cardiac ultrasound. [ Time Frame: baseline, 18th month ]
  9. Change from base line in left ventricular ejection fraction and end-diastolic dimention by cardiac ultrasound. [ Time Frame: baseline, 21st month ]
  10. Change from base line in left ventricular ejection fraction and end-diastolic dimention by cardiac ultrasound. [ Time Frame: baseline, 24th month ]
  11. Change from baseline in N-terminal pro-brain natriuretic peptide level.natriuretic peptide level. [ Time Frame: baseline, 3rd month ]
  12. Change from baseline in N-terminal pro-brain natriuretic peptide level.natriuretic peptide level. [ Time Frame: baseline, 6th month ]
  13. Change from baseline in N-terminal pro-brain natriuretic peptide level.natriuretic peptide level. [ Time Frame: baseline, 9th month ]
  14. Change from baseline in N-terminal pro-brain natriuretic peptide level.natriuretic peptide level. [ Time Frame: baseline, 12th month ]
  15. Change from baseline in N-terminal pro-brain natriuretic peptide level.natriuretic peptide level. [ Time Frame: baseline, 15th month ]
  16. Change from baseline in N-terminal pro-brain natriuretic peptide level.natriuretic peptide level. [ Time Frame: baseline, 18th month ]
  17. Change from baseline in N-terminal pro-brain natriuretic peptide level.natriuretic peptide level. [ Time Frame: baseline, 21st month ]
  18. Change from baseline in N-terminal pro-brain natriuretic peptide level.natriuretic peptide level. [ Time Frame: baseline, 24th month ]

Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v3.0 [ Time Frame: Up to 24 months ]
    We will check patient's biochemistry profile including, lipid profile, liver function and renal function. Treatment-related adverse events would be assessed by CTCAE v3.0



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have already received anti-congestive medications for at least three months and still have compromised LV function (LVEF < 45% and the Z score of the LV end-diastolic diameter > 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 week.

Exclusion Criteria:

  • Patients who underwent prior cardiac surgery.
  • Patients who had liver / renal dysfunction.
  • Patients who are pregnant or plan to pregnancy in the period of study.
  • Patients who are intolerance to simvastatin therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775070


Contacts
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Contact: Wei-Chieh Tseng, M.D. +886-2-23123456 ext 66257 littlecardiologist@gmail.com

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Wei-Chieh Tseng, M.D.    +886223123456 ext 66257    littlecardiologist@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03775070     History of Changes
Other Study ID Numbers: 201806014MIPB
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Cardiomegaly
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors