Status:

UNKNOWN

Effects of Atorvastatin Treatment on Left Ventricular Diastolic Function in Peritoneal Dialysis Patients

Lead Sponsor:

National Taiwan University Hospital

Conditions:

Heart Failure

Eligibility:

All Genders

20-90 years

Phase:

PHASE4

Brief Summary

Background Heart failure is the final consequence of various heart disease and is also the leading cause of mortality worldwide. Diastolic dysfunction refers to an abnormality of diastolic distensibi...

Detailed Description

We will evaluate left ventricular diastolic function noninvasively by echocardiography before and after the intervention. Exclusion criteria include coronary artery disease, significant valvular heart...

Eligibility Criteria

Inclusion

  • Outpatients ≥ 20 year of age, male or female with essential hypertension
  • Patients must be on a stable condition of CAPD for at least 6 months.

Exclusion

  • History of hypersensitivity to any of the study drugs.
  • Current acute decompensated HF (exacerbation of chronic HF manifested by signs \& symptoms that may require IV therapy).
  • Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or major vascular surgery, percutaneous coronary intervention (PCI) or carotid angioplasty, within the past 3 months prior to visit 1.
  • Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 6 months after Visit 1.
  • Right heart failure due to severe pulmonary disease.
  • Diagnosis of peripartum or chemotherapy induced cardiomyopathy within the 12 months prior to visit 1.
  • Patients with a history of heart transplant or who are on a transplant list or with left ventricular assistance device (LVAD device).
  • Documented ventricular arrhythmia with syncopal episodes within past 3 months, prior to visit 1, that is untreated.
  • Symptomatic bradycardia or second or third degree heart block without a pacemaker.
  • Implantation of a CRT (cardiac resynchronization therapy) device within the prior 3 months from visit 1 or intent to implant a CRT device.
  • Presence of hemodynamically significant mitral and/or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation.
  • Presence of other hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic and sub-aortic stenosis.
  • Severe primary pulmonary, renal or hepatic disease judged by physicians.
  • Presence of any other disease with a life expectancy of \< 1 year.
  • Chronic long-term requirement for NSAIDs (high dose) or COX2 inhibitors, with the exception of aspirin at doses used for CV prophylaxis (≤325 mg o.d.).
  • Subjects are now breast feeding, get pregnant or will be pregnant within 6 months.

Key Trial Info

Start Date :

November 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 1 2015

Estimated Enrollment :

36 Patients enrolled

Trial Details

Trial ID

NCT01503671

Start Date

November 1 2011

End Date

October 1 2015

Last Update

August 11 2015

Active Locations (1)

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1

National Taiwan University Hospital

Taipei, Taiwan, 100