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Simvastatin and Diastolic Dysfunction

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ClinicalTrials.gov Identifier: NCT01061450
Recruitment Status : Completed
First Posted : February 3, 2010
Last Update Posted : February 3, 2010
Fundação de Amparo a Pesquisa do Distrito Federal
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Diastolic Dysfunction Hypertension Drug: Simvastatin Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of the Addition of Simvastatin to Enalapril in Hypertensive Individuals With Average Cholesterol Levels and Diastolic Dysfunction
Study Start Date : November 2006
Primary Completion Date : July 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
Drug: Placebo
1 pill once a day
Experimental: Simvastatin
Simvastatin 80 mg/day
Drug: Simvastatin
80 mg once a day
Other Name: Zocor

Primary Outcome Measures :
  1. Changes in E/A ratio and e' wave velocity [ Time Frame: 20 weeks ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01061450

Instituto de Cardiologia do Distrito Federal
Brasilia, DF, Brazil, 70000.000
Sponsors and Collaborators
Brasilia Heart Study Group
Fundação de Amparo a Pesquisa do Distrito Federal
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Principal Investigator: Adenalva LS Beck, MD InCor Heart Institute
Study Chair: Andrei C Sposito, MD, PhD University of Brasilia Medical School, Brasilia, Brazil
Principal Investigator: Maria E Otto, MD, PhD Instituto de Cardiologia do Distrito Federal, Brasilia, Brazil

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrei C Sposito, Heart Institute (InCor), University of São Paulo Medical School, São Paulo, Brazil
ClinicalTrials.gov Identifier: NCT01061450     History of Changes
Other Study ID Numbers: Statin_DD
First Posted: February 3, 2010    Key Record Dates
Last Update Posted: February 3, 2010
Last Verified: February 2010

Keywords provided by Brasilia Heart Study Group:
Diastolic dysfunction
ACE inhibitor

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors