Simvastatin and Diastolic Dysfunction

Phase 4

Completed

• Conditions: Diastolic Dysfunction; Hypertension
• Interventions: Drug: Placebo; Drug: Simvastatin

• Registration Number: NCT01061450
• Lead Sponsor: Brasilia Heart Study Group

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2009-07
• Study Completion: 2009-08
• Status Verified: 2010-02
• Study First Submitted: 2010-02-02
• Study First Submitted QC: 2010-02-02
• Last Update Submitted: 2010-02-02
• Study First Posted: 2010-02-03
• Last Update Posted: 2010-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• men or postmenopausal women aged between 40 and 65 years old
• normal fasting blood glucose (<100 mg/dL) and glucose tolerance test (<140 mg/dL)
• waist circumference < 102 cm (men) or < 88cm (women)
• triglycerides <150 mg/dL, LDL cholesterol ≤ 160 mg/dl
• creatinine <1.2 mg/dL, sinus rhythm
• the presence of grade 1 or 2 of DD with an ejection fraction of left ventricle > 55%
• absence of myocardial ischemia during dobutamine stress echocardiography

Exclusion Criteria

• thyroid dysfunction
• acute or chronic liver disease
• regular use of 3 or more antihypertensive drugs
• secondary hypertension
• symptoms or history of atherosclerotic disease
• valvular dysfunction
• LVH 14 and use of statins in the last 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Simvastatin	Simvastatin	Simvastatin 80 mg/day

Primary Outcome Measures

Name	Time	Method
Changes in E/A ratio and e' wave velocity	20 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in the ratio of mitral inflow velocity to annular relaxation velocity.	20 weeks
Changes in e´/a´ waves ratio.	20 weeks
Changes in mitral deceleration time.	20 weeks
Changes in left atrium volume.	20 weeks
Changes in left ventricular mass.	20 weeks
Changes in mitral annulus systolic velocity	20 weeks
Diastolic function reserve index measured at peak stress with dobutamine	20 weeks

Trial Locations

Locations (1)

Instituto de Cardiologia do Distrito Federal; 🇧🇷 Brasilia, DF, Brazil