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OpenTrials
Completed

NCT Number: NCT01061450

Simvastatin and Diastolic Dysfunction

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.

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Key information

Conditions

Diastolic Dysfunction Cardiovascular Diseases Hypertension Vascular Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Instituto de Cardiologia do Distrito Federal

Brasília, Federal District, 70000.000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

simvastatin

Drug

80 mg once a day

Other names: Zocor

Placebo

Drug

1 pill once a day

Primary outcomes

  1. Changes in E/A ratio and e' wave velocity

    Time frame: 20 weeks

Secondary outcomes

  1. Changes in left atrium volume.

    Time frame: 20 weeks

  2. Changes in left ventricular mass.

    Time frame: 20 weeks

  3. Changes in e´/a´ waves ratio.

    Time frame: 20 weeks

  4. Changes in mitral deceleration time.

    Time frame: 20 weeks

  5. Changes in the ratio of mitral inflow velocity to annular relaxation velocity.

    Time frame: 20 weeks

  6. Changes in mitral annulus systolic velocity

    Time frame: 20 weeks

  7. Diastolic function reserve index measured at peak stress with dobutamine

    Time frame: 20 weeks

Sponsors and collaborators

Lead sponsor

Brasilia Heart Study Group

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Fundação de Amparo a Pesquisa do Distrito Federal

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Feb 3, 2010
Registry last updated
Feb 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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