NCT00229242

Brief Summary

MAIN: The benefits of treating high blood pressure successfully to normal levels on heart function are the same regardless of which particular combination of drugs are used. SECONDARY: Measurement of heart function using a comprehensive ultrasound imaging method (Echocardiography) and an objective test of functional ability are better predictors of changes in heart function with successful hypertension treatment, than subjective signs of heart failure.

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 not_applicable hypertension

Timeline
Completed

Started Nov 2003

Typical duration 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

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 29, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

December 14, 2009

Status Verified

December 1, 2009

Enrollment Period

3.1 years

First QC Date

September 13, 2005

Last Update Submit

December 11, 2009

Conditions

Hypertension

Keywords

Ambulatory blood pressure monitoringEchocardiographyDiastolic functionLeft ventricular mass regression

Outcome Measures

Primary Outcomes (3)

  • Measurement of systolic and diastolic function in responders to therapy

    0, 3 and 6 months

  • LV mass in responders

    0, 3 and 6 months

  • Change in 6-minute walk distance in responders

    0, 3, and 6 months

Secondary Outcomes (2)

  • Correlation between interval improvement or deterioration in Framingham score and corresponding change in echocardiographic classification in all subjects

    3 and 6 months

  • Correlation between interval improvement or deterioration in LV Mass and corresponding change in 6 minute walk distance and diastolic function in all subjects

    3 and 6 months

Study Arms (2)

1

ACTIVE COMPARATOR

Diuretic-Based Hypertension Therapy

Drug: Diuretic-Based or Non-Diuretic Based Hypertension Therapy

2

ACTIVE COMPARATOR

Non-Diuretic-Based Hypertension Therapy

Drug: Diuretic-Based or Non-Diuretic Based Hypertension Therapy

Interventions

Diuretic-Based or Non-Diuretic Based Hypertension TherapyDRUG
12

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age 20-65 years;
  • Hypertension with average 24-hour BP of \>130 mmHg systolic or \>80 mmHg diastolic in spite of treatment with one medication;
  • Office systolic blood pressure \>140 mmHg and less than 180mmHg;
  • Able to comprehend and sign the consent form;
  • Able to tolerate either hydrochlorothiazide 25 mg or amlodipine 5 mg daily for 3 weeks during the run-in phase.

You may not qualify if:

  • Diagnosis of secondary hypertension;
  • Hypertension with systolic BP \>180 mmHg in spite of 1 medication;
  • Chronic heart failure requiring diuretics, Angina or coronary syndrome requiring anti-angina therapy with CCB or beta blockers, or more than 0.4 mg/hr nitroglycerine patch;
  • Left Ventricular Ejection Fraction (LVEF) \<20% or LV end systolic dimension \>75 mm;
  • Significant valvular disease such as; more than mild disease of aortic or mitral valve;
  • Technically sub-optimal acoustic window or regional wall motion abnormalities;
  • Patients currently on both CCB and diuretics for more than 4 weeks;
  • Normal 24 hour ABPM at the end of the run-in period;
  • Physical handicap that precludes adequate performance of 6-minute walk such as arthritis;
  • Concomitant comorbidity that might compromise ability to evaluate treatment or enhance risks of therapy, such as: atrial fibrillation with resting ventricular rate of \>100 bpm; morbid obesity; uncontrolled diabetes mellitus; severe chronic obstructive pulmonary disease (COPD); hypertrophic cardiomyopathy; and documented history of non-compliance with treatment;
  • Any condition or disorder other than hypertension that: Requires prolonged hospitalization; May limit life expectancy within 2 years; would increase the risk of participation to the subject (in the opinion of the investigator).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Related Publications (1)

  • Ogunyankin KO, Day AG. Successful treatment of hypertension accounts for improvements in markers of diastolic function - a pilot study comparing hydrochlorothiazide-based and amlodipine-based treatment strategies. Can J Cardiol. 2009 Dec;25(12):e406-12. doi: 10.1016/s0828-282x(09)70534-3.

    PMID: 19960134RESULT

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Kofo O Ogunyankin, MD, FACC

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 29, 2005

Study Start

November 1, 2003

Primary Completion

December 1, 2006

Study Completion

March 1, 2007

Last Updated

December 14, 2009

Record last verified: 2009-12

Locations

CA(1)