NCT01442116

Brief Summary

The study hypothesis is stress-related regional tissue dynamics is related to left ventricular outflow tract blood flow.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Jun 2009

Shorter than P25 for not_applicable hypertension

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

June 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 28, 2011

Completed
Last Updated

September 29, 2011

Status Verified

September 1, 2011

Enrollment Period

6 months

First QC Date

September 15, 2011

Last Update Submit

September 28, 2011

Conditions

HypertensionLeft Ventricular Hypertrophy

Outcome Measures

Primary Outcomes (2)

  • measurement of LVOT velocity before and after exercise by echocardiography

    1 day (before and after exercise stress)

  • measurement of TDI S wave before and after exercise by echocardiography

    1 day (before and after exercise)

Secondary Outcomes (1)

  • myocardial regional functions measured by tissue Doppler imagination

    1 day

Study Arms (1)

Hypertensives

EXPERIMENTAL
Procedure: stress echocardiography

Interventions

stress echocardiographyPROCEDURE

safety and efficacy of stress echocardiography

Hypertensives

Eligibility Criteria

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

You may qualify if:

  • Essential hypertension

You may not qualify if:

  • History of Myocardial Infarction
  • Diabetes Mellitus
  • Renal Failure
  • Orthopedic problems

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

MeSH Terms

Conditions

HypertensionHypertrophy, Left Ventricular

Condition Hierarchy (Ancestors)

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

Study Officials

  • Fatih Yalcin, MD

    Mustafa Kemal University: Turkey

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 15, 2011

First Posted

September 28, 2011

Study Start

June 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

September 29, 2011

Record last verified: 2011-09

Locations

TU(1)