HypertensionTRHNCT02167464
Controlling Blood Pressure in Treatment Resistant Hypertension: A Pilot Study
A study testing Renin treatment-guided Therapeutics, Referral Hypertension specialist and Aldosterone Antagonist in people with Hypertension, run by Medical University of South Carolina at 8 sites in United States.
Trial summary
Comparative Effectiveness Research using an intent-to-treat approach in 8 clinics in South Carolina. The investigators will assess 4 efficacious approaches to controlling treatment-resistant hypertension (TRH): Aldosterone Antagonist, Referral to Hypertension Specialist, Renin Treatment-Guided Therapeutics, and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Renin treatment-guided Therapeutics, Referral Hypertension specialist and Aldosterone Antagonist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2011to Jan 2015
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Treatment Resistant Hypertension (TRH)
- On three or more hypertensive medications at therapeutic dose
- BpTRU measurement on two occasions of >135/85 without diabetes or chronic kidney disease or BP >125/75 if diabetes and/or chronic kidney disease.
- Mean of >10 BP readings of >135/85 mm mercury for those with no diabetes or chronic kidney disease
- Mean of >10 home BP readings of >125/75 mm mercury for those with diabetes and/or chronic kidney disease.
Who cannot join
- Less than 18 years of age
- Refuses or incompetent to provide consent
- BP controlled to goal in or outside the clinic
- Symptomatic or significant orthostatic hypotension (<20/10 on standing)
- Life-threatening or severe illness
- Currently on protocol
- Myocardial Infarction or stroke in the past 6 months
- Estimated Glomerular Filtration Rate <50 ml/1.7/min.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
AnMed
Anderson, South Carolina, 29621
Beaufort Jasper Hampton Comprehensive Health
Beaufort, South Carolina, 29935
McLeod Family Medicine Center
Florence, South Carolina, 29506
Family Diagnostics
Holly Hill, South Carolina, 29059
Lovelace Family Medicine
Prosperity, South Carolina, 29127
Carolina Medical Affiliates
Spartanburg, South Carolina, 29303
Spartanburg Regional Health Services
Spartanburg, South Carolina, 29303
Palmetto Primary Care
Summerville, South Carolina, 29485
About this study
Comparative Effectiveness Research using an intent-to-treat approach in 8 clinics in South Carolina. The investigators will assess 4 efficacious approaches to controlling treatment-resistant hypertension (TRH): Aldosterone Antagonist, Referral to Hypertension Specialist, Renin Treatment-Guided Therapeutics, and combination of Hypertension Specialist and Renin Treatment-Guided Therapeutics. Patients with TRH are evaluated with the BpTRU device for an accurate and representative blood pressure measure on two occasions before entry into the study. Qualitative data from focus group discussions with practice staff, and patient surveys and interviews will provide contextual data to help explain why some interventions are more acceptable and successful than others.
Read the detailed description
This is Comparative Effectiveness Research conducted in the real world of under-resourced primary care clinics in South Carolina. Four arms of the study are identified with two clinics/arm enrolling and following patients with TRH. The goal is to compare rates of BP control according to American Heart Association guidelines among the 4 arms, along with clinic and patient satisfaction with each approach.
Our hypothesis is that defining pathophysiological mechanisms (e.g. renin treatment-guided therapeutics) with or without referral to a hypertension specialist will improve blood pressure control over adding an aldosterone antagonist in eligible patients or just referring patients to a hypertension specialist.
This mixed-methods design captures medical and qualitative data to not only describe the outcome of blood pressure control, but to assess the impact of the four interventions on staff and patient satisfaction. Key patient data includes demographics, visits, blood pressure values, medications and laboratory data. Focus group discussions with practice staff before and after the study will document early attitudes toward each arm, any practice changes needed to implement each arm and any burdens of the intervention on the practice. Patient surveys and interviews will assess their satisfaction with each intervention along with their experiences in participating in this research project.
Treatment Resistant Hypertension is a common medical condition, and relatively ineffective treatment regimens are a significant contributing factor. The long-term goal is to establish practice and effective approaches for controlling blood pressure and reducing clinical complications and related health disparities.
- Conditions
- Hypertension
- Being tested
- Renin treatment-guided Therapeutics, Referral Hypertension specialist, Aldosterone Antagonist
- Keywords
- Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renin treatment-guided TherapeuticsDrug
Patients are treated based upon their renin levels according to an approved algorithm.
Referral Hypertension specialistOther
Patients are referred to a hypertension specialist.
Aldosterone AntagonistDrug
Spironolactone 12.5 - 25mg daily
| Study group | Role | What they receive |
|---|---|---|
| Aldosterone Antagonist | Active comparator | Prescribe an aldosterone antagonist such as Spironolactone 12.5-25 mg daily as a starting dose with a maximum recommended dose of 50 mg daily. Receives: Drug: Aldosterone Antagonist |
| Referral Hypertension specialist | Active comparator | Referral to a hypertension specialist Receives: Other: Referral Hypertension specialist |
| Renin treatment-guided therapeutics | Active comparator | Renin treatment-guided therapeutics. A treatment algorithm is provided to guide treatment based upon renin levels. Receives: Drug: Renin treatment-guided Therapeutics |
| Renin-guided therapeutics and referral | Active comparator | Renin treatment-guided therapeutics and referral to hypertension specialist. Treatment based upon algorithm for treatment related to renin level in addition to referral to a hypertension specialist. Receives: Drug: Renin treatment-guided Therapeutics; Other: Referral Hypertension specialist |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure control
Blood pressure control will be assessed according to guidelines established by American Heart Association.
Measured: four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study startJun 2011
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Carolina
- Responsible party
- Sponsor
- Investigators
- Marilyn A Laken, PhD, RN, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167464
- Sponsor's protocol ID
- R34HL105880
- Acronym
- TRH
- Status last verified
- Sep 2014
- First submitted
- 17 Jun 2014
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data file is available. Email Suparna Qanungo at MUSC.
Publications
Laken MA, Dawson R, Engelman O, Lovelace O, Way C, Egan BM. Comparative effectiveness research in the "real" world: lessons learned in a study of treatment-resistant hypertension. J Am Soc Hypertens. 2013 Jan-Feb;7(1):95-101. doi: 10.1016/j.jash.2012.12.002.
PubMed 23321408Egan BM, Laken MA, Sutherland SE, Qanungo S, Fleming DO, Cook AG, Hester WH, Jones KW, Jebaily GC, Valainis GT, Way CF, Wright MB, Davis RA. Aldosterone Antagonists or Renin-Guided Therapy for Treatment-Resistant Hypertension: A Comparative Effectiveness Pilot Study in Primary Care. Am J Hypertens. 2016 Aug;29(8):976-83. doi: 10.1093/ajh/hpw016. Epub 2016 Apr 13.
PubMed 27076600
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlling Blood Pressure in Treatment Resistant Hypertension: A Pilot Study
- ClinicalTrials.gov ID
- NCT02167464
- Acronym / sponsor ID
- TRH / R34HL105880
- Conditions
- Hypertension
- Keywords
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- University of South Carolina
- Study start
- Jun 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 19 Jun 2014 (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.
Comparative Effectiveness Research using an intent-to-treat approach in 8 clinics in South Carolina. The investigators will assess 4 efficacious approaches to controlling treatment-resistant hypertension (TRH): Aldosterone Antagonist, Referral to Hypertension Specialist, Renin Treatment-Guided Therapeutics, and combination of Hypertension Specialist and Renin Treatment-Guided Therapeutics. Patients with TRH are evaluated with the BpTRU device for an accurate and representative blood pressure measure on two occasions before entry into the study. Qualitative data from focus group discussions with practice staff, and patient surveys and interviews will provide contextual data to help explain why some interventions are more acceptable and successful than others.
Detailed description
This is Comparative Effectiveness Research conducted in the real world of under-resourced primary care clinics in South Carolina. Four arms of the study are identified with two clinics/arm enrolling and following patients with TRH. The goal is to compare rates of BP control according to American Heart Association guidelines among the 4 arms, along with clinic and patient satisfaction with each approach.
Our hypothesis is that defining pathophysiological mechanisms (e.g. renin treatment-guided therapeutics) with or without referral to a hypertension specialist will improve blood pressure control over adding an aldosterone antagonist in eligible patients or just referring patients to a hypertension specialist.
This mixed-methods design captures medical and qualitative data to not only describe the outcome of blood pressure control, but to assess the impact of the four interventions on staff and patient satisfaction. Key patient data includes demographics, visits, blood pressure values, medications and laboratory data. Focus group discussions with practice staff before and after the study will document early attitudes toward each arm, any practice changes needed to implement each arm and any burdens of the intervention on the practice. Patient surveys and interviews will assess their satisfaction with each intervention along with their experiences in participating in this research project.
Treatment Resistant Hypertension is a common medical condition, and relatively ineffective treatment regimens are a significant contributing factor. The long-term goal is to establish practice and effective approaches for controlling blood pressure and reducing clinical complications and related health disparities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aldosterone Antagonist | Active comparator | Drug: Aldosterone AntagonistPrescribe an aldosterone antagonist such as Spironolactone 12.5-25 mg daily as a starting dose with a maximum recommended dose of 50 mg daily. |
| Referral Hypertension specialist | Active comparator | Other: Referral Hypertension specialistReferral to a hypertension specialist |
| Renin treatment-guided therapeutics | Active comparator | Drug: Renin treatment-guided TherapeuticsRenin treatment-guided therapeutics. A treatment algorithm is provided to guide treatment based upon renin levels. |
| Renin-guided therapeutics and referral | Active comparator | Drug: Renin treatment-guided Therapeutics, Other: Referral Hypertension specialistRenin treatment-guided therapeutics and referral to hypertension specialist. Treatment based upon algorithm for treatment related to renin level in addition to referral to a hypertension specialist. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of Treatment Resistant Hypertension (TRH)
- On three or more hypertensive medications at therapeutic dose
- BpTRU measurement on two occasions of >135/85 without diabetes or chronic kidney disease or BP >125/75 if diabetes and/or chronic kidney disease.
- Mean of >10 BP readings of >135/85 mm mercury for those with no diabetes or chronic kidney disease
- Mean of >10 home BP readings of >125/75 mm mercury for those with diabetes and/or chronic kidney disease.
Key exclusion criteria (8 listed)
- Less than 18 years of age
- Refuses or incompetent to provide consent
- BP controlled to goal in or outside the clinic
- Symptomatic or significant orthostatic hypotension (<20/10 on standing)
- Life-threatening or severe illness
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 |
|---|---|---|
| Renin treatment-guided TherapeuticsPatients are treated based upon their renin levels according to an approved algorithm. | Drug | Renin treatment-guided therapeutics, Renin-guided therapeutics and referral |
| Referral Hypertension specialistPatients are referred to a hypertension specialist. | Other | Referral Hypertension specialist, Renin-guided therapeutics and referral |
| Aldosterone AntagonistSpironolactone 12.5 - 25mg daily | Drug | Aldosterone Antagonist |
Primary outcome
blood pressure control
Time frame: four months
Blood pressure control will be assessed according to guidelines established by American Heart Association.
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 23 Jul 2018.
- Background: PubMed 23321408Laken MA, Dawson R, Engelman O, Lovelace O, Way C, Egan BM. Comparative effectiveness research in the "real" world: lessons learned in a study of treatment-resistant hypertension. J Am Soc Hypertens. 2013 Jan-Feb;7(1):95-101. doi: 10.1016/j.jash.2012.12.002.
- Results publication: PubMed 27076600Egan BM, Laken MA, Sutherland SE, Qanungo S, Fleming DO, Cook AG, Hester WH, Jones KW, Jebaily GC, Valainis GT, Way CF, Wright MB, Davis RA. Aldosterone Antagonists or Renin-Guided Therapy for Treatment-Resistant Hypertension: A Comparative Effectiveness Pilot Study in Primary Care. Am J Hypertens. 2016 Aug;29(8):976-83. doi: 10.1093/ajh/hpw016. Epub 2016 Apr 13.
- Individual participant dataSharing planned: Yes. De-identified data file is available. Email Suparna Qanungo at MUSC.
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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.
Marilyn A Laken, PhD, RN principal investigator
Medical University of South Carolina
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renin treatment-guided Therapeutics, Referral Hypertension specialist and Aldosterone Antagonist in people with Hypertension, run by Medical University of South Carolina at 8 sites 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 5 inclusion and 8 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 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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.
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?
blood pressure control (time frame: four months). 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 NCT02167464, which also lists 2 linked publications.
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 23 Jul 2018.