NCT01425411

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 30, 2011

Completed
Last Updated

August 30, 2011

Status Verified

August 1, 2011

Enrollment Period

2 years

First QC Date

August 18, 2011

Last Update Submit

August 29, 2011

Conditions

HypertensionLeft Ventricular Hypertrophy

Keywords

hypertensionleft ventricular hypertrophyangiotensin receptor blockermidwall mechanicstissue Doppler imagingHypertension with left ventricular hypertrophy

Outcome Measures

Primary Outcomes (1)

  • change from baseline in midwall fractional shortening (mFS) and tissue Doppler systolic wave (Sm) measured by echocardiography at six months

    six months

Secondary Outcomes (2)

  • change from baseline in systolic and diastolic blood pressure at six months

    six months

  • change from baseline in left ventricular mass index measured by echocardiography at six months

    six months

Study Arms (1)

Valsartan treatment

EXPERIMENTAL
Drug: valsartan

Interventions

valsartanDRUG

80/160 mg dosage of valsartan or 160+12,5 mg valsartan+hydrochlorothiazide combination, once a day, for six months

Also known as: Diovan 80 mg, Diovan 160 mg, Co-diovan 160/12,5 mg
Valsartan treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hypertension with left ventricular hypertrophy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mustafa Kemal University School of Medicine, Department of Cardiology

Antioch, Antioch, 31100, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 22306782DERIVED

MeSH Terms

Conditions

HypertensionHypertrophy, Left Ventricular

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesCardiomegalyHeart DiseasesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • Fatih Yalcin, M.D.

    Mustafa Kemal University: Turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 18, 2011

First Posted

August 30, 2011

Study Start

November 1, 2006

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

August 30, 2011

Record last verified: 2011-08

Locations

TU(1)