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NCT01425411 Clinical Trial

Effect of Valsartan on Left Ventricular Myocardial Functions in Hypertensive Patients With Left Ventricular Hypertrophy

Hypertension Clinical Trial

Official title:
Effect of Valsartan on Left Ventricular Myocardial Functions in Hypertensive Patients With Left Ventricular Hypertrophy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01425411
Other study ID # vals262626
Secondary ID
Status Completed
Phase Phase 4
First received August 18, 2011
Last updated August 29, 2011
Start date November 2006
Est. completion date November 2008

Study information
Verified date August 2011
Source Mustafa Kemal University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial Summary

The study hypothesis: Valsartan as an angiotensin II receptor blocker treatment has beneficial effects on both midwall mechanics and myocardial functions in hypertensive patients with Left ventricular hypertrophy.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date November 2008
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- hypertension with left ventricular hypertrophy

Exclusion Criteria:

- clinical or laboratory evidence of secondary hypertension

- heart failure

- ischemic heart disease

- valvular heart disease

- arrhythmias

- peripheral vascular disease

- chronic obstructive pulmonary disease

- neurologic disorders

- diabetes mellitus

- renal dysfunction

- notable systemic disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• valsartan
80/160 mg dosage of valsartan or 160+12,5 mg valsartan+hydrochlorothiazide combination, once a day, for six months

Locations
Country Name City State
Turkey Mustafa Kemal University School of Medicine, Department of Cardiology Antioch

Sponsors (2)
Lead Sponsor Collaborator
Mustafa Kemal University Novartis Pharmaceuticals

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary change from baseline in midwall fractional shortening (mFS) and tissue Doppler systolic wave (Sm) measured by echocardiography at six months six months Yes
Secondary change from baseline in systolic and diastolic blood pressure at six months six months Yes
Secondary change from baseline in left ventricular mass index measured by echocardiography at six months six months Yes
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