Simvastatin Therapy in Patients With Dilated Cardiomyopathy.

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Brief Title

Simvastatin Therapy in Patients With Dilated Cardiomyopathy.

Official Title

An Open Label, Single-armed, Exploratory Study of Simvastatin Therapy on the Cardiac Function in Patients With Dilated Cardiomyopathy.

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.
    

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Change from base line in left ventricular ejection fraction and end-diastolic dimention by cardiac ultrasound.

Secondary Outcome

 Number of participants with treatment-related adverse events as assessed by CTCAE v3.0

Condition

Dilated Cardiomyopathy

Intervention

Simvastatin

Study Arms / Comparison Groups

 Simvastatin
Description:  Simvastatin, 0.5mg/kg/d(maximum 20mg), once daily

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

30

Start Date

December 31, 2018

Completion Date

October 2021

Primary Completion Date

October 2021

Eligibility 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.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

, +886-2-23123456, [email protected]

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations


NCT ID

NCT03775070

Organization ID

201806014MIPB


Responsible Party

Sponsor

Study Sponsor

National Taiwan University Hospital


Study Sponsor

, , 


Verification Date

March 2020