Left Atrial Remodelling in Hypertension: Effects of Ramipril or Irbesartan
Sponsor
Università degli Studi dell'Insubria (Other)
Overall Status
Unknown status
CT.gov ID
NCT00517322
Collaborator
(none)
80
1
2
36
2.2
Study Details
Study Description
Brief Summary
Aim of the study is to compare in hypertensive patients the effect of one year therapy with ACE-inhibitor (RAMIPRIL) or angiotensin II receptor blocker (IRBESARTAN) on left atrial remodelling and diastolic function.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Left Atrial Remodelling in Hypertension: Effects of Ramipril or Irbesartan
Study Start Date
:
Aug 1, 2007
Anticipated Study Completion Date
:
Aug 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 treatment with ramipril |
Drug: ramipril
ramipril 2.5- 5 mg once daily
|
| Experimental: 2 treatment with irbesartan |
Drug: irbesartan
irbesartan 150-300 mg once daily
|
Outcome Measures
Primary Outcome Measures
- left atrial volume [one year]
- diastolic function [one year]
Secondary Outcome Measures
- systolic and diastolic blood pressure [one year]
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:·
-
mild to moderate essential hypertension
-
no antihypertensive treatment
-
good quality echocardiogram
Exclusion Criteria:
-
cardiovascular diseases (AMI, stroke o TIA)
-
heart failure, valvular heart disease
-
diabetes
-
secondary hypertension
-
atrial fibrillation
-
hepatic and renal severe failure
-
pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Insubria-Department of Clinical Medicine | Varese | Italy | 21100 |
Sponsors and Collaborators
- Università degli Studi dell'Insubria
Investigators
- Principal Investigator: anna maria grandi, MD, Università degli Studi dell'Insubria
Study Documents (Full-Text)
None provided.More Information
Publications
- Healey JS, Baranchuk A, Crystal E, Morillo CA, Garfinkle M, Yusuf S, Connolly SJ. Prevention of atrial fibrillation with angiotensin-converting enzyme inhibitors and angiotensin receptor blockers: a meta-analysis. J Am Coll Cardiol. 2005 Jun 7;45(11):1832-9.
- Lang RM, Bierig M, Devereux RB, Flachskampf FA, Foster E, Pellikka PA, Picard MH, Roman MJ, Seward J, Shanewise JS, Solomon SD, Spencer KT, Sutton MS, Stewart WJ; Chamber Quantification Writing Group; American Society of Echocardiography's Guidelines and Standards Committee; European Association of Echocardiography. Recommendations for chamber quantification: a report from the American Society of Echocardiography's Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology. J Am Soc Echocardiogr. 2005 Dec;18(12):1440-63.
- Matsuda M, Matsuda Y. Mechanism of left atrial enlargement related to ventricular diastolic impairment in hypertension. Clin Cardiol. 1996 Dec;19(12):954-9.
- Tsang TS, Barnes ME, Gersh BJ, Bailey KR, Seward JB. Left atrial volume as a morphophysiologic expression of left ventricular diastolic dysfunction and relation to cardiovascular risk burden. Am J Cardiol. 2002 Dec 15;90(12):1284-9.
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00517322
Other Study ID Numbers:
- 1112
First Posted:
Aug 16, 2007
Last Update Posted:
Aug 16, 2007
Last Verified:
Aug 1, 2007
Keywords provided by ,
,
Additional relevant MeSH terms: