Controlling Blood Pressure in Treatment Resistant Hypertension: A Pilot Study
TRH
1 other identifier
interventional
70
1 country
8
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hypertension
Started Jun 2011
Longer than P75 for not_applicable hypertension
8 active sites
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, 2011
CompletedFirst Submitted
Initial submission to the registry
June 17, 2014
CompletedFirst Posted
Study publicly available on registry
June 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedJuly 23, 2018
September 1, 2014
3.6 years
June 17, 2014
July 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
blood pressure control
Blood pressure control will be assessed according to guidelines established by American Heart Association.
four months
Study Arms (4)
Aldosterone Antagonist
ACTIVE COMPARATORPrescribe 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 COMPARATORReferral to a hypertension specialist
Renin treatment-guided therapeutics
ACTIVE COMPARATORRenin treatment-guided therapeutics. A treatment algorithm is provided to guide treatment based upon renin levels.
Renin-guided therapeutics and referral
ACTIVE COMPARATORRenin 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.
Interventions
Patients are treated based upon their renin levels according to an approved algorithm.
Patients are referred to a hypertension specialist.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical University of South Carolinalead
- University of South Carolinacollaborator
Study Sites (8)
AnMed
Anderson, South Carolina, 29621, United States
Beaufort Jasper Hampton Comprehensive Health
Beaufort, South Carolina, 29935, United States
McLeod Family Medicine Center
Florence, South Carolina, 29506, United States
Family Diagnostics
Holly Hill, South Carolina, 29059, United States
Lovelace Family Medicine
Prosperity, South Carolina, 29127, United States
Carolina Medical Affiliates
Spartanburg, South Carolina, 29303, United States
Spartanburg Regional Health Services
Spartanburg, South Carolina, 29303, United States
Palmetto Primary Care
Summerville, South Carolina, 29485, United States
Related Publications (2)
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.
PMID: 23321408BACKGROUNDEgan 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.
PMID: 27076600RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marilyn A Laken, PhD, RN
Medical University of South Carolina
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The PI was blinded to clinic and group assignment when he conducted the final statistical analysis.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2014
First Posted
June 19, 2014
Study Start
June 1, 2011
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
July 23, 2018
Record last verified: 2014-09
Data Sharing
- IPD Sharing
- Will share
De-identified data file is available. Email Suparna Qanungo at MUSC.