MedTrace Logo

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

NCT01503671 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-08-11

No results posted yet for this study

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 distensibility, filling, or relaxation of the left ventricle. Patients with hypertensive left ventricular hypertrophy and an echocardiogram showing a normal ejection fraction and abnormal left ventricular filling can be said to have diastolic dysfunction. If pulmonary edema or effort dyspnea developed in such a patient. The term diastolic heart failure would be appropriate.

Pathology leading to diastolic heart failure include: impaired relaxation, increased passive stiffness, endocardial and pericardial disorders, microvascular flow and neurohormonal regulation. Among them, the association of pro-inflammatory system and diastolic dysfunction are already established. The investigators therefore hypothesized that the change of serum inflammatory markers might be associated with the change of left ventricular diastolic function and the investigators thus conducted a randomized case-control trial with this regard.

Method and materials

This is a case-control randomized study. The definition of left ventricular diastolic function is according to Guideline from the ACC and AHA. The investigators will evaluate left ventricular diastolic function noninvasively by echocardiography before and after the intervention. Exclusion criteria include coronary artery disease, significant valvular heart disease, cardiomyopathy, pericardial disease and renal insufficiency. The investigators would like to enroll 50 cases and the same numbers of the controls. The inclusion criteria are subjects who underwent peritoneal dialysis at the investigators hospital for more than 6 months with higher pro-inflammation serum cytokine levels (C-reactive protein \> 0.2mg/dL). Atorvastatin (40mg/day) would be given to those who were allocated to the intervention group. The investigators will than follow up cardiac diastolic function by echocardiography and also the change of serum markers. The investigators would also genotype the inflammation-associated genes and their promoter region and find the association between genetic polymorphisms and the treatment effects of statins.

Conditions

Interventions

DRUG

Atorvastatin

Atorvastatin 40 mg/day

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Cho-Kai Wu, MD · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01503671 on ClinicalTrials.gov