Effect of Valsartan on Left Ventricular Myocardial Functions in Hypertensive Patients With Left Ventricular Hypertrophy
Primary Purpose
Hypertension, Left Ventricular Hypertrophy
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
valsartan
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring hypertension, left ventricular hypertrophy, angiotensin receptor blocker, midwall mechanics, tissue Doppler imaging, Hypertension with left ventricular hypertrophy
Eligibility Criteria
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
Sites / Locations
- Mustafa Kemal University School of Medicine, Department of Cardiology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Valsartan treatment
Arm Description
Outcomes
Primary Outcome Measures
change from baseline in midwall fractional shortening (mFS) and tissue Doppler systolic wave (Sm) measured by echocardiography at six months
Secondary Outcome Measures
change from baseline in systolic and diastolic blood pressure at six months
change from baseline in left ventricular mass index measured by echocardiography at six months
Full Information
NCT ID
NCT01425411
First Posted
August 18, 2011
Last Updated
August 29, 2011
Sponsor
Mustafa Kemal University
Collaborators
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01425411
Brief Title
Effect of Valsartan on Left Ventricular Myocardial Functions in Hypertensive Patients With Left Ventricular Hypertrophy
Official Title
Effect of Valsartan on Left Ventricular Myocardial Functions in Hypertensive Patients With Left Ventricular Hypertrophy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mustafa Kemal University
Collaborators
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Left Ventricular Hypertrophy
Keywords
hypertension, left ventricular hypertrophy, angiotensin receptor blocker, midwall mechanics, tissue Doppler imaging, Hypertension with left ventricular hypertrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Valsartan treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
valsartan
Other Intervention Name(s)
Diovan 80 mg, Diovan 160 mg, Co-diovan 160/12,5 mg
Intervention Description
80/160 mg dosage of valsartan or 160+12,5 mg valsartan+hydrochlorothiazide combination, once a day, for six months
Primary Outcome Measure Information:
Title
change from baseline in midwall fractional shortening (mFS) and tissue Doppler systolic wave (Sm) measured by echocardiography at six months
Time Frame
six months
Secondary Outcome Measure Information:
Title
change from baseline in systolic and diastolic blood pressure at six months
Time Frame
six months
Title
change from baseline in left ventricular mass index measured by echocardiography at six months
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatih Yalcin, M.D.
Organizational Affiliation
Mustafa Kemal University: Turkey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mustafa Kemal University School of Medicine, Department of Cardiology
City
Antioch
ZIP/Postal Code
31100
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
22306782
Citation
Kucukler N, Kurt IH, Topaloglu C, Gurbuz S, Yalcin F. The effect of valsartan on left ventricular myocardial functions in hypertensive patients with left ventricular hypertrophy. J Cardiovasc Med (Hagerstown). 2012 Mar;13(3):181-6. doi: 10.2459/JCM.0b013e3283511f00.
Results Reference
derived
Learn more about this trial
Effect of Valsartan on Left Ventricular Myocardial Functions in Hypertensive Patients With Left Ventricular Hypertrophy
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