HypertensionNCT00229242
Comparison of Diuretic-based With Non-diuretic Based Hypertension Therapy Using Echocardiographic Measures
A study testing Diuretic-Based or Non-Diuretic Based Hypertension Therapy in people with Hypertension, run by Queen's University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Diuretic-Based or Non-Diuretic Based Hypertension Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2003to Mar 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Successful treatment of hypertension with single medications is very rare. On average successful treatment requires more than 2 medications. These medications work by different methods. One of the ideas behind the use of combinations of medication for hypertension is that benefits are additive. There are unresolved questions about whether the observed benefits are simply related to effective treatment of hypertension, or whether some of the medications have special benefits independent of blood pressure lowering. Each of these contentions has been justified by clinical trials. However these trials have in common the flaw that hypertension is either not effectively controlled in all the treated subjects, or the magnitude of blood pressure change after treatment is different in the groups compared. The result of one of the largest blood pressure clinical trials called ALLHAT trial has recently fuelled this debate. The ALLHAT trial which utilized only subjective symptoms and signs of heart failure, called the FRAMINGHAM score, to determine who has abnormal heart function, implied that diuretics (water pills) were superior to the newer drugs in reducing the frequency of abnormal heart function. This study shared the flaw of previous trials in not having equal blood pressure lowering in the groups. Nevertheless it provided some evidence that argued against the notion that newer drugs were better than older drugs like diuretics. Shortly after the publication of ALLHAT, another trial called ANBP was published showing that the group of drugs that was least effective in ALLHAT was superior to diuretics in preventing important cardiovascular outcomes. Hence, it is not currently clear that there are differences between various drug combinations, if effective and equal blood pressure lowering is achieved. Another finding that may have confounded clinical trials that rely on subjective scores of heart dysfunction such as the ALLHAT, is that a significant proportion of subjects with advanced heart disease are unaware of their heart problem and hence will probably not seek attention. This raises the concern that the true frequency of abnormal heart function might not have been reported in those studies. Using more modern tools such as Echocardiography, a more complete assessment of heart dysfunction can be obtained. In addition objective tests of heart function such as the 6-minute walk distance could yield a more reliable assessment of any worsening or improvement in heart function if performed serially in treated subjects. In view of the above discussion, only a study in which hypertension is effectively and similarly controlled could be used to answer the questions regarding different effects of various drug combinations. Such is this study proposed.
- Conditions
- Hypertension
- Being tested
- Diuretic-Based or Non-Diuretic Based Hypertension Therapy
- Keywords
- Ambulatory blood pressure monitoring, Echocardiography, Diastolic function, Left ventricular mass regression
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diuretic-Based or Non-Diuretic Based Hypertension TherapyDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Diuretic-Based Hypertension Therapy Receives: Drug: Diuretic-Based or Non-Diuretic Based Hypertension Therapy |
| 2 | Active comparator | Non-Diuretic-Based Hypertension Therapy Receives: Drug: Diuretic-Based or Non-Diuretic Based Hypertension Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of systolic and diastolic function in responders to therapy
Measured: 0, 3 and 6 months
LV mass in responders
Measured: 0, 3 and 6 months
Change in 6-minute walk distance in responders
Measured: 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
Measured: 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
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2005 (estimated)
- Study startNov 2003
- Primary completionDec 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Kofo O Ogunyankin, MD, FACC, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229242
- Sponsor's protocol ID
- DMED-676-03
- Status last verified
- Dec 2009
- First submitted
- 13 Sep 2005
- Last updated
- 14 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19960134
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Diuretic-based With Non-diuretic Based Hypertension Therapy Using Echocardiographic Measures
- ClinicalTrials.gov ID
- NCT00229242
- Acronym / sponsor ID
- DMED-676-03
- Conditions
- Hypertension
- Keywords
- Ambulatory blood pressure monitoring, Echocardiography, Diastolic function, Left ventricular mass regression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Nov 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 29 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Successful treatment of hypertension with single medications is very rare. On average successful treatment requires more than 2 medications. These medications work by different methods. One of the ideas behind the use of combinations of medication for hypertension is that benefits are additive. There are unresolved questions about whether the observed benefits are simply related to effective treatment of hypertension, or whether some of the medications have special benefits independent of blood pressure lowering. Each of these contentions has been justified by clinical trials. However these trials have in common the flaw that hypertension is either not effectively controlled in all the treated subjects, or the magnitude of blood pressure change after treatment is different in the groups compared. The result of one of the largest blood pressure clinical trials called ALLHAT trial has recently fuelled this debate. The ALLHAT trial which utilized only subjective symptoms and signs of heart failure, called the FRAMINGHAM score, to determine who has abnormal heart function, implied that diuretics (water pills) were superior to the newer drugs in reducing the frequency of abnormal heart function. This study shared the flaw of previous trials in not having equal blood pressure lowering in the groups. Nevertheless it provided some evidence that argued against the notion that newer drugs were better than older drugs like diuretics. Shortly after the publication of ALLHAT, another trial called ANBP was published showing that the group of drugs that was least effective in ALLHAT was superior to diuretics in preventing important cardiovascular outcomes. Hence, it is not currently clear that there are differences between various drug combinations, if effective and equal blood pressure lowering is achieved. Another finding that may have confounded clinical trials that rely on subjective scores of heart dysfunction such as the ALLHAT, is that a significant proportion of subjects with advanced heart disease are unaware of their heart problem and hence will probably not seek attention. This raises the concern that the true frequency of abnormal heart function might not have been reported in those studies. Using more modern tools such as Echocardiography, a more complete assessment of heart dysfunction can be obtained. In addition objective tests of heart function such as the 6-minute walk distance could yield a more reliable assessment of any worsening or improvement in heart function if performed serially in treated subjects. In view of the above discussion, only a study in which hypertension is effectively and similarly controlled could be used to answer the questions regarding different effects of various drug combinations. Such is this study proposed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Diuretic-Based or Non-Diuretic Based Hypertension TherapyDiuretic-Based Hypertension Therapy |
| 2 | Active comparator | Drug: Diuretic-Based or Non-Diuretic Based Hypertension TherapyNon-Diuretic-Based Hypertension Therapy |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diuretic-Based or Non-Diuretic Based Hypertension Therapy | Drug | 1, 2 |
Primary outcome
Measurement of systolic and diastolic function in responders to therapy
Time frame: 0, 3 and 6 months
LV mass in responders
Time frame: 0, 3 and 6 months
Change in 6-minute walk distance in responders
Time frame: 0, 3, and 6 months
2 secondary outcomes
Correlation between interval improvement or deterioration in Framingham score and corresponding change in echocardiographic classification in all subjects
Time frame: 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
Time frame: 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2009.
- Results publication: PubMed 19960134Ogunyankin 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.
- Manuscript of resultLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kofo O Ogunyankin, MD, FACC principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diuretic-Based or Non-Diuretic Based Hypertension Therapy in people with Hypertension, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of systolic and diastolic function in responders to therapy (time frame: 0, 3 and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00229242, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2009.