drugset / Trial / NCT01503671

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

NCT01503671 ↗

Phase 4 Unknown 36 enrolled National Taiwan University Hospital
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2011-11
Primary completion
2015-10
Completion
2015-10

Outcome

Met primary endpoint

paper Nominal change for E/Emedial: -5.01 ± 6.36 vs 1.80 ± 6.59 for atorvastatin and control, respectively, P = .02 PMID 28506387 ↗

paper atorvastatin significantly improved cardiac diastolic function PMID 28506387 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 40 mg —