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

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Nagehan Kucukler, Mustafa Kemal University
ClinicalTrials.gov Identifier:
NCT01425411
First received: August 18, 2011
Last updated: August 29, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Hypertension
Left Ventricular Hypertrophy
Drug: valsartan
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Valsartan on Left Ventricular Myocardial Functions in Hypertensive Patients With Left Ventricular Hypertrophy

Resource links provided by NLM:


Further study details as provided by Mustafa Kemal University:

Primary Outcome Measures:
  • change from baseline in midwall fractional shortening (mFS) and tissue Doppler systolic wave (Sm) measured by echocardiography at six months [ Time Frame: six months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • change from baseline in systolic and diastolic blood pressure at six months [ Time Frame: six months ] [ Designated as safety issue: Yes ]
  • change from baseline in left ventricular mass index measured by echocardiography at six months [ Time Frame: six months ] [ Designated as safety issue: Yes ]

Enrollment: 38
Study Start Date: November 2006
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01425411

Locations
Turkey
Mustafa Kemal University School of Medicine, Department of Cardiology
Antioch, Turkey, 31100
Sponsors and Collaborators
Mustafa Kemal University
Novartis Pharmaceuticals
Investigators
Principal Investigator: Fatih Yalcin, M.D. Mustafa Kemal University: Turkey
  More Information

No publications provided by Mustafa Kemal University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nagehan Kucukler, MD, Mustafa Kemal University
ClinicalTrials.gov Identifier: NCT01425411     History of Changes
Other Study ID Numbers: vals262626
Study First Received: August 18, 2011
Last Updated: August 29, 2011
Health Authority: Turkey: Ethics Committee

Keywords provided by Mustafa Kemal University:
hypertension
left ventricular hypertrophy
angiotensin receptor blocker
midwall mechanics
tissue Doppler imaging
Hypertension with left ventricular hypertrophy

Additional relevant MeSH terms:
Hypertension
Hypertrophy
Hypertrophy, Left Ventricular
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Cardiomegaly
Heart Diseases
Valsartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014