NCT01061450

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2010

Completed
Last Updated

February 3, 2010

Status Verified

February 1, 2010

Enrollment Period

2.7 years

First QC Date

February 2, 2010

Last Update Submit

February 2, 2010

Conditions

Diastolic DysfunctionHypertension

Keywords

Diastolic dysfunctionhypertensionStatinsACE inhibitorEchocardiography

Outcome Measures

Primary Outcomes (1)

  • Changes in E/A ratio and e' wave velocity

    20 weeks

Secondary Outcomes (7)

  • Changes in left atrium volume.

    20 weeks

  • Changes in left ventricular mass.

    20 weeks

  • Changes in e´/a´ waves ratio.

    20 weeks

  • Changes in mitral deceleration time.

    20 weeks

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

    20 weeks

  • +2 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Simvastatin

EXPERIMENTAL

Simvastatin 80 mg/day

Drug: Simvastatin

Interventions

SimvastatinDRUG

80 mg once a day

Also known as: Zocor
Simvastatin
PlaceboDRUG

1 pill once a day

Placebo

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Cardiologia do Distrito Federal

Brasília, Federal District, 70000.000, Brazil

Location

Related Publications (1)

  • Beck AL, Otto ME, D'Avila LB, Netto FM, Armendaris MK, Sposito AC. Diastolic function parameters are improved by the addition of simvastatin to enalapril-based treatment in hypertensive individuals. Atherosclerosis. 2012 Jun;222(2):444-8. doi: 10.1016/j.atherosclerosis.2012.03.030. Epub 2012 Apr 3.

    PMID: 22554359DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Adenalva LS Beck, MD

    InCor Heart Institute

    PRINCIPAL INVESTIGATOR

  • Andrei C Sposito, MD, PhD

    University of Brasilia Medical School, Brasilia, Brazil

    STUDY CHAIR

  • Maria E Otto, MD, PhD

    Instituto de Cardiologia do Distrito Federal, Brasilia, Brazil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 2, 2010

First Posted

February 3, 2010

Study Start

November 1, 2006

Primary Completion

July 1, 2009

Study Completion

August 1, 2009

Last Updated

February 3, 2010

Record last verified: 2010-02

Locations

BR(1)