HypertensionPhase 4NCT01748123
EBMtrialcentral- Comparing Initial Diuretic Therapies Using a Collaborative Network
A Phase 4 study testing Chlorthalidone and Hydrochlorothiazide in people with Hypertension, run by Johns Hopkins University at 1 site in United States.
Trial summary
Clinical equipoise exists with respect to the important question, "What is the best initial diuretic for the treatment of Hypertension"? A pragmatic comparative effectiveness research (CER) study comparing Chlorthalidone to Hydrochlorthiazide (HCTZ) could help inform decision making for this common problem. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Chlorthalidone and Hydrochlorothiazide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Jun 2018
- Phase
- Phase 4
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women are eligible if they have hypertension, are not receiving antihypertensive medications, and have average office BP values within the last 6 months ≥140/90 mmHg.
Who cannot join
- Patients with hypertensive urgency will be excluded (BP ≥180/120 mmHg). We also plan to exclude those with "compelling indications" for an Angiotensin Converting Enzyme (ACE) inhibitor or Beta-blocker therapy (per JNC 7). These include those with; a history of diabetes (prior HbA1c ≥6.5%, fasting glucose ≥126mg/dl, a history of insulin or oral hypoglycemic use, or microalbuminuria), myocardial infarction within the last 3 years, and a known LVEF <50%. Other safety exclusions will be; a history of chronic kidney disease (or a serum creatinine ≥1.8 mg/dL), known allergy to study medications, inability to provide consent, a history of significant non-compliance or missed appointments, a history of poorly-controlled gout and a history of falls or autonomic dysfunction and subjects aged <21years or ≥90yrs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Creating an Active Collaborative Network of Comparative Effectiveness Researchers: A Randomized Study of Initial Diuretic Therapy for Hypertension.
- Clinical equipoise exists with respect to the important question, "What is the best initial diuretic for the treatment of Hypertension"? A pragmatic comparative effectiveness research (CER) study comparing Chlorthalidone to Hydrochlorthiazide (HCTZ) could help inform decision making for this common problem.
- The investigators aim to harness both the power of bioinformatics (using web-based data-capture and electronic health records) and of online media (through collaboration) in order to facilitate such a CER in "usual-care" settings. This process may also provide a foundation for testing a wealth of important clinical questions which commonly arise in the delivery of contemporary healthcare and would otherwise be left unanswered.
- To this end the investigators are developing a website, EBMtrialcentral, where eligible physicians can go online and join their collaborative network. Physicians can then enroll eligible patients in this study. These will include under-served urban patients. Clinical information will be entered online (using a secure database housed at Johns Hopkins), patient consent will be obtained electronically and treatment recommendations will be randomly allocated to either 25mg daily of oral HCTZ or 12.5mg daily of oral Chlorthalidone. The investigators aim to increase to 50mg HCTZ and 25mg Chlorthalidone over 8 weeks and compare their effects on BP measured with a 24 hour monitor.
- The investigators' primary hypothesis is that non-blinded, random, parallel allocation of 12.5mg daily Chlorthalidone (titrated to 25mg at 4 weeks) will demonstrate a clinically meaningful ≥5mmHg improvement in BP control (as measured by change in BP from baseline using 24hr ABPM) compared to 25mg daily HCTZ (titrated to 50mg at 4 weeks) in newly hypertensive patients followed in a usual-care clinic setting over 8 weeks. They will also analyze differences in side-effects or safety (serum electrolytes) between these two medications.
Read the detailed description
- BACKGROUND:
The application of many traditional randomized controlled trial(RCT) findings to real-world practice is in question. To this end, comparative effectiveness research(CER) has evolved. However, there remains ample evidence that U.S. trials are becoming increasingly cumbersome and expensive. Moreover, 90 percent fail to meet enrollment goals.
In contrast, there have been significant recent technological advances in both bioinformatics and social media. However, thus-far, the combined potential of both has yet to be achieved in the field of medicine. The stage is now set for an amalgamation of these three disciplines; CER, bioinformatics and social media. EBMtrialcentral is a non-profit website developed at Johns Hopkins University with the idea of using an online social network to actually perform CER trials. By harnessing the power of social media, EBMtrialcentral could open up a world of opportunity for conducting clinical research and bring randomization into "usual care".
- OBJECTIVES:
- To determine if a social network website can be created, among a group of academic physicians, with the pre-specified objective of using this website to conduct a CER trial.
- To perform a pilot-study though the website. This study will randomly allocate initial anti-hypertensive treatment strategies, using guideline recommended diuretic agents.
- METHODS:
- Website development-A test website, EBMtrialcentral.org, has been initiated. By visiting the website, eligible physicians will be able to join the collaborative network. Once a member physician identifies an eligible patient who agrees to participate, consent forms will be generated online for formal enrollment. A therapeutic strategy will be randomly allocated via the website. The investigators' platform would require parsimonious imputation of secured patient data. Follow-up will be pragmatic and guideline-directed. Data will initially be managed in a protected online database run by "project REDCap". Patients and patient advocate stakeholders will be invited to help with IRB and website development.
- Pilot study-Despite stronger evidence for chlorthalidone, most hypertensive patients prescribed diuretics currently receive HCTZ. However, the two have not been randomly compared in an adequately powered study. The investigators will require 80 newly hypertensive urban subjects to detect a greater than 5mmHg mean automated BP difference between the two groups over 2 monthly follow-up visits (8 weeks total, with a standardized effect size of 0.7 based on prior data). The investigators will include ethnic and under-served subjects. Exclusion criteria will include compelling indications for alternative anti-hypertensives. Non-blinded random allocation will be generated online.
- Conditions
- Hypertension
- Being tested
- Chlorthalidone, Hydrochlorothiazide
- Keywords
- Pragmatic, Comparative Effectiveness
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChlorthalidoneDrug
Also called Hygroton, Tenoretic
Initial dose of 12.5mg daily Chlorthalidone (force titrated to 25mg at 4 weeks)
HydrochlorothiazideDrug
Also called Apo-hydro, Aquazide h, Dichlotride, Oretic
Initial dose 25mg daily HCTZ (force titrated to 50mg at 4 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Chlorthalidone | Active comparator | 25mg daily orally for 8 weeks Receives: Drug: Chlorthalidone |
| Hydrochlorothiazide | Active comparator | 50mg daily orally for 8 weeks Receives: Drug: Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean systolic 24 Hour Ambulatory Blood Pressure
Measured: 8 weeks
Secondary outcomes (1)
Subjective Medication Side Effects
Measured: 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startAug 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2018 (estimated)
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven P Schulman, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748123
- Sponsor's protocol ID
- PCORI-EGID 4231
- Other IDs
- 00041242
- Status last verified
- Aug 2017
- First submitted
- 10 Dec 2012
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating an Active Collaborative Network of Comparative Effectiveness Researchers: A Randomized Study of Initial Diuretic Therapy for Hypertension.
- ClinicalTrials.gov ID
- NCT01748123
- Acronym / sponsor ID
- PCORI-EGID 4231
- Conditions
- Hypertension
- Keywords
- Pragmatic, Comparative Effectiveness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Slow enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 12 Dec 2012 (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.
- Clinical equipoise exists with respect to the important question, "What is the best initial diuretic for the treatment of Hypertension"? A pragmatic comparative effectiveness research (CER) study comparing Chlorthalidone to Hydrochlorthiazide (HCTZ) could help inform decision making for this common problem.
- The investigators aim to harness both the power of bioinformatics (using web-based data-capture and electronic health records) and of online media (through collaboration) in order to facilitate such a CER in "usual-care" settings. This process may also provide a foundation for testing a wealth of important clinical questions which commonly arise in the delivery of contemporary healthcare and would otherwise be left unanswered.
- To this end the investigators are developing a website, EBMtrialcentral, where eligible physicians can go online and join their collaborative network. Physicians can then enroll eligible patients in this study. These will include under-served urban patients. Clinical information will be entered online (using a secure database housed at Johns Hopkins), patient consent will be obtained electronically and treatment recommendations will be randomly allocated to either 25mg daily of oral HCTZ or 12.5mg daily of oral Chlorthalidone. The investigators aim to increase to 50mg HCTZ and 25mg Chlorthalidone over 8 weeks and compare their effects on BP measured with a 24 hour monitor.
- The investigators' primary hypothesis is that non-blinded, random, parallel allocation of 12.5mg daily Chlorthalidone (titrated to 25mg at 4 weeks) will demonstrate a clinically meaningful ≥5mmHg improvement in BP control (as measured by change in BP from baseline using 24hr ABPM) compared to 25mg daily HCTZ (titrated to 50mg at 4 weeks) in newly hypertensive patients followed in a usual-care clinic setting over 8 weeks. They will also analyze differences in side-effects or safety (serum electrolytes) between these two medications.
Detailed description
- BACKGROUND:
The application of many traditional randomized controlled trial(RCT) findings to real-world practice is in question. To this end, comparative effectiveness research(CER) has evolved. However, there remains ample evidence that U.S. trials are becoming increasingly cumbersome and expensive. Moreover, 90 percent fail to meet enrollment goals.
In contrast, there have been significant recent technological advances in both bioinformatics and social media. However, thus-far, the combined potential of both has yet to be achieved in the field of medicine. The stage is now set for an amalgamation of these three disciplines; CER, bioinformatics and social media. EBMtrialcentral is a non-profit website developed at Johns Hopkins University with the idea of using an online social network to actually perform CER trials. By harnessing the power of social media, EBMtrialcentral could open up a world of opportunity for conducting clinical research and bring randomization into "usual care".
- OBJECTIVES:
- To determine if a social network website can be created, among a group of academic physicians, with the pre-specified objective of using this website to conduct a CER trial.
- To perform a pilot-study though the website. This study will randomly allocate initial anti-hypertensive treatment strategies, using guideline recommended diuretic agents.
- METHODS:
- Website development-A test website, EBMtrialcentral.org, has been initiated. By visiting the website, eligible physicians will be able to join the collaborative network. Once a member physician identifies an eligible patient who agrees to participate, consent forms will be generated online for formal enrollment. A therapeutic strategy will be randomly allocated via the website. The investigators' platform would require parsimonious imputation of secured patient data. Follow-up will be pragmatic and guideline-directed. Data will initially be managed in a protected online database run by "project REDCap". Patients and patient advocate stakeholders will be invited to help with IRB and website development.
- Pilot study-Despite stronger evidence for chlorthalidone, most hypertensive patients prescribed diuretics currently receive HCTZ. However, the two have not been randomly compared in an adequately powered study. The investigators will require 80 newly hypertensive urban subjects to detect a greater than 5mmHg mean automated BP difference between the two groups over 2 monthly follow-up visits (8 weeks total, with a standardized effect size of 0.7 based on prior data). The investigators will include ethnic and under-served subjects. Exclusion criteria will include compelling indications for alternative anti-hypertensives. Non-blinded random allocation will be generated online.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorthalidone | Active comparator | Drug: Chlorthalidone25mg daily orally for 8 weeks |
| Hydrochlorothiazide | Active comparator | Drug: Hydrochlorothiazide50mg daily orally for 8 weeks |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women are eligible if they have hypertension, are not receiving antihypertensive medications, and have average office BP values within the last 6 months ≥140/90 mmHg.
Key exclusion criteria (1 listed)
- Patients with hypertensive urgency will be excluded (BP ≥180/120 mmHg). We also plan to exclude those with "compelling indications" for an Angiotensin Converting Enzyme (ACE) inhibitor or Beta-blocker therapy (per JNC 7). These include those with; a history of diabetes (prior HbA1c ≥6.5%, fasting glucose ≥126mg/dl, a history of insulin or oral hypoglycemic use, or microalbuminuria), myocardial infarction within the last 3 years, and a known LVEF <50%. Other safety exclusions will be; a history of chronic kidney disease (or a serum creatinine ≥1.8 mg/dL), known allergy to study medications, inability to provide consent, a history of significant non-compliance or missed appointments, a history of poorly-controlled gout and a history of falls or autonomic dysfunction and subjects aged <21years or ≥90yrs.
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 |
|---|---|---|
| ChlorthalidoneAlso: Hygroton, TenoreticInitial dose of 12.5mg daily Chlorthalidone (force titrated to 25mg at 4 weeks) | Drug | Chlorthalidone |
| HydrochlorothiazideAlso: Apo-hydro, Aquazide h, Dichlotride, OreticInitial dose 25mg daily HCTZ (force titrated to 50mg at 4 weeks) | Drug | Hydrochlorothiazide |
Primary outcome
Mean systolic 24 Hour Ambulatory Blood Pressure
Time frame: 8 weeks
1 secondary outcome
Subjective Medication Side Effects
Time frame: 4 and 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
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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.
Steven P Schulman, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chlorthalidone and Hydrochlorothiazide in people with Hypertension, run by Johns Hopkins University at 1 site in United States.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 18 Aug 2017. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Mean systolic 24 Hour Ambulatory Blood Pressure (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2017.