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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

Tracking Information
First Submitted Date  ICMJE August 18, 2011
First Posted Date  ICMJE August 30, 2011
Last Update Posted Date August 30, 2011
Study Start Date  ICMJE November 2006
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2011)		 change from baseline in midwall fractional shortening (mFS) and tissue Doppler systolic wave (Sm) measured by echocardiography at six months [ Time Frame: six months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2011)
  • change from baseline in systolic and diastolic blood pressure at six months [ Time Frame: six months ]
  • change from baseline in left ventricular mass index measured by echocardiography at six months [ Time Frame: six months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Valsartan on Left Ventricular Myocardial Functions in Hypertensive Patients With Left Ventricular Hypertrophy
Official Title  ICMJE Effect of Valsartan on Left Ventricular Myocardial Functions in Hypertensive Patients With Left Ventricular Hypertrophy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Left Ventricular Hypertrophy
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Valsartan treatment
Intervention: Drug: valsartan
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 29, 2011)		 38
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01425411
Other Study ID Numbers  ICMJE vals262626
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Nagehan Kucukler, Mustafa Kemal University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Mustafa Kemal University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Novartis Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Fatih Yalcin, M.D. Mustafa Kemal University: Turkey
PRS Account Mustafa Kemal University
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP