NCT01503671

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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for phase_4 heart-failure

Timeline
Completed

Started Nov 2011

Longer than P75 for phase_4 heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

August 11, 2015

Status Verified

August 1, 2015

Enrollment Period

3.9 years

First QC Date

January 2, 2012

Last Update Submit

August 9, 2015

Conditions

Heart Failure

Keywords

left ventricular diastolic functioninflammationperitoneal dialysisLV diastolic function changes after statin intervention

Outcome Measures

Primary Outcomes (1)

  • Left ventricular diastolic function

    We will arrange UCG follow up to delineate the change of LV diastolic function after intervention

    1 year

Secondary Outcomes (3)

  • Mortality

    1 year

  • Major cardiovascular events

    1 year

  • Side effects

    1 year

Study Arms (2)

Atorvastatin

EXPERIMENTAL

Atorvastatin 40 mg/day for high inflammation CAPD patient

Drug: Atorvastatin

No intervention arm

NO INTERVENTION

Placebo arm without intervention

Interventions

AtorvastatinDRUG

Atorvastatin 40 mg/day

Also known as: Lipitor
Atorvastatin

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.).
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (1)

  • Wu CK, Yeh CF, Chiang JY, Lin TT, Wu YF, Chiang CK, Kao TW, Hung KY, Huang JW. Effects of atorvastatin treatment on left ventricular diastolic function in peritoneal dialysis patients-The ALEVENT clinical trial. J Clin Lipidol. 2017 May-Jun;11(3):657-666. doi: 10.1016/j.jacl.2017.02.016. Epub 2017 Mar 18.

    PMID: 28506387DERIVED

MeSH Terms

Conditions

Heart FailureInflammation

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Cho-Kai Wu, MD

    National Taiwan University Hospital

    STUDY CHAIR

Central Study Contacts

Cho-Kai Wu, MD

CONTACT

886-23123456chokaiwu@yahoo.com.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2012

First Posted

January 4, 2012

Study Start

November 1, 2011

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

August 11, 2015

Record last verified: 2015-08

Locations

TW(1)