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Simvastatin and Diastolic Dysfunction

NCT01061450 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2010-02-03

No results posted yet for this study

Summary

Diastolic dysfunction (DD) is an increasingly frequent condition in hypertensive individuals whose treatment remains unclear. Its presence is related to higher morbidity and mortality independent of blood pressure levels. The aim of this study is to investigate the additive effect of simvastatin on enalapril on DD in hypertensive patients with average cholesterol levels.

For this aim, hypertensive patients with DD and LDL-cholesterol \<160 mg/dL will undergo a run-in phase to achieve a systolic blood pressure (SBP) \<135 mmHg and diastolic blood pressure (DBP) \<85 mmHg with enalapril. Hydrochlorothiazide could be added when need to achieve SBP or DBP control. Four weeks after reaching the optimum anti-hypertensive regimen patients will be randomized to receive 80 mg simvastatin or placebo for a period of 20 weeks. Echocardiograms will be performed before and after treatment with measurement of left atrial volume, conventional and tissue Doppler velocities in early diastole and late diastole. The evaluation of these will allow to identify changes of DD severity after treatment.

Conditions

Interventions

DRUG

Simvastatin

80 mg once a day

DRUG

Placebo

1 pill once a day

Sponsors & Collaborators

  • Fundação de Amparo a Pesquisa do Distrito Federal

    collaborator UNKNOWN

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

    collaborator OTHER_GOV

  • Brasilia Heart Study Group

    lead OTHER

Principal Investigators

  • Adenalva LS Beck, MD · InCor Heart Institute

  • Andrei C Sposito, MD, PhD · University of Brasilia Medical School, Brasilia, Brazil

  • Maria E Otto, MD, PhD · Instituto de Cardiologia do Distrito Federal, Brasilia, Brazil

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2009-07-31
Completion
2009-08-31

Countries

  • Brazil

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 NCT01061450 on ClinicalTrials.gov