Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2026-01-01 @ 8:04 PM
Study NCT ID:
NCT01061450
Status:
COMPLETED
Last Update Posted:
2010-02-03
First Post:
2010-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simvastatin and Diastolic Dysfunction
Sponsor:
Brasilia Heart Study Group
Organization:
Study Overview
Official Title:
Effect of the Addition of Simvastatin to Enalapril in Hypertensive Individuals With Average Cholesterol Levels and Diastolic Dysfunction
Status:
COMPLETED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: