Simvastatin and Diastolic Dysfunction

Brasilia Heart Study Group

Status and phase: Completed; Phase 4

Conditions: Hypertension; Diastolic Dysfunction

Treatments: Drug: Placebo; Drug: Simvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01061450

Statin_DD

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

55 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Simvastatin

Experimental group

Description:

Simvastatin 80 mg/day

Treatment:

Drug: Simvastatin