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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01425411
Recruitment Status : Completed
First Posted : August 30, 2011
Last Update Posted : August 30, 2011
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Nagehan Kucukler, Mustafa Kemal University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypertension Left Ventricular Hypertrophy Drug: valsartan Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Valsartan on Left Ventricular Myocardial Functions in Hypertensive Patients With Left Ventricular Hypertrophy
Study Start Date : November 2006
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Valsartan

Arms and Interventions
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Arm Intervention/treatment
Experimental: Valsartan treatment Drug: valsartan
80/160 mg dosage of valsartan or 160+12,5 mg valsartan+hydrochlorothiazide combination, once a day, for six months
Other Names:
  • Diovan 80 mg
  • Diovan 160 mg
  • Co-diovan 160/12,5 mg


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. change from baseline in systolic and diastolic blood pressure at six months [ Time Frame: six months ]
  2. change from baseline in left ventricular mass index measured by echocardiography at six months [ Time Frame: six months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01425411


Locations
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Turkey
Mustafa Kemal University School of Medicine, Department of Cardiology
Antioch, Turkey, 31100
Sponsors and Collaborators
Mustafa Kemal University
Novartis Pharmaceuticals
Investigators
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Principal Investigator: Fatih Yalcin, M.D. Mustafa Kemal University: Turkey
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nagehan Kucukler, MD, Mustafa Kemal University
ClinicalTrials.gov Identifier: NCT01425411    
Other Study ID Numbers: vals262626
First Posted: August 30, 2011    Key Record Dates
Last Update Posted: August 30, 2011
Last Verified: August 2011
Keywords provided by Nagehan Kucukler, Mustafa Kemal University:
hypertension
left ventricular hypertrophy
angiotensin receptor blocker
 midwall mechanics
tissue Doppler imaging
Hypertension with left ventricular hypertrophy
Additional relevant MeSH terms:
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Hypertension
Hypertrophy, Left Ventricular
Hypertrophy
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Cardiomegaly
 Heart Diseases
Valsartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action