Simvastatin and Diastolic Dysfunction

Hypertension Clinical Trial

Official title:

Effect of the Addition of Simvastatin to Enalapril in Hypertensive Individuals With Average Cholesterol Levels and Diastolic Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061450
• Other study ID #: Statin_DD
• Status: Completed
• Phase: Phase 4
• First received: February 2, 2010
• Last updated: February 2, 2010
• Start date: November 2006
• Est. completion date: August 2009

Study information

• Verified date: February 2010
• Source: Brasilia Heart Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: August 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diastolic Dysfunction
• Hypertension

Intervention

Drug:
• Simvastatin
80 mg once a day
• Placebo
1 pill once a day

Locations

Country	Name	City	State
Brazil	Instituto de Cardiologia do Distrito Federal	Brasilia	DF

Sponsors (3)

Lead Sponsor	Collaborator
Brasilia Heart Study Group	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo a Pesquisa do Distrito Federal

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in E/A ratio and e' wave velocity		20 weeks	No
Secondary	Changes in left atrium volume.		20 weeks	No
Secondary	Changes in left ventricular mass.		20 weeks	No
Secondary	Changes in e´/a´ waves ratio.		20 weeks	No
Secondary	Changes in mitral deceleration time.		20 weeks	No
Secondary	Changes in the ratio of mitral inflow velocity to annular relaxation velocity.		20 weeks	No
Secondary	Changes in mitral annulus systolic velocity		20 weeks	No
Secondary	Diastolic function reserve index measured at peak stress with dobutamine		20 weeks	No