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

August 29, 2011 updated by: Nagehan Kucukler, Mustafa Kemal University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antioch, Turkey, 31100
        • Mustafa Kemal University School of Medicine, Department of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change from baseline in midwall fractional shortening (mFS) and tissue Doppler systolic wave (Sm) measured by echocardiography at six months
Time Frame: six months
six months

Secondary Outcome Measures

Outcome Measure
Time Frame
change from baseline in systolic and diastolic blood pressure at six months
Time Frame: six months
six months
change from baseline in left ventricular mass index measured by echocardiography at six months
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mustafa Kemal University

Collaborators

Novartis Pharmaceuticals

Investigators

  • Principal Investigator: Fatih Yalcin, M.D., Mustafa Kemal University: Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (ACTUAL)

November 1, 2008

Study Completion (ACTUAL)

November 1, 2008

Study Registration Dates

First Submitted

August 18, 2011

First Submitted That Met QC Criteria

August 29, 2011

First Posted (ESTIMATE)

August 30, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 30, 2011

Last Update Submitted That Met QC Criteria

August 29, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • vals262626

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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