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Simvastatin and Diastolic Dysfunction

This study has been completed.
Sponsor:
Collaborators:
Fundação de Amparo a Pesquisa do Distrito Federal
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by:
Brasilia Heart Study Group
ClinicalTrials.gov Identifier:
NCT01061450
First received: February 2, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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 Intervention Phase
Diastolic Dysfunction
Hypertension
 Drug: Simvastatin
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

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

Further study details as provided by Brasilia Heart Study Group:

Primary Outcome Measures:
  • Changes in E/A ratio and e' wave velocity [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in left atrium volume. [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Changes in left ventricular mass. [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Changes in e´/a´ waves ratio. [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Changes in mitral deceleration time. [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Changes in the ratio of mitral inflow velocity to annular relaxation velocity. [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Changes in mitral annulus systolic velocity [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Diastolic function reserve index measured at peak stress with dobutamine [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: November 2006
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
1 pill once a day
Other Name: Placebo
Experimental: Simvastatin
Simvastatin 80 mg/day
 Drug: Simvastatin
80 mg once a day
Other Name: Zocor

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061450

Locations
Brazil
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.
Investigators
Principal Investigator: Adenalva LS Beck, MD Heart Institute (InCor), University of São Paulo Medical School, São Paulo, Brazil
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
  More Information

No publications provided by Brasilia Heart Study Group

Additional 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
Study First Received: February 2, 2010
Last Updated: February 2, 2010
Health Authority: Brazil: National Committee of Ethics in Research

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Simvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013