Controlling Blood Pressure in Treatment Resistant Hypertension: A Pilot Study
- Conditions
- Hypertension
- Interventions
- Drug: Renin treatment-guided TherapeuticsOther: Referral Hypertension specialist
- Registration Number
- NCT02167464
- Lead Sponsor
- Medical University of South Carolina
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Renin-guided therapeutics and referral Renin treatment-guided Therapeutics 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. Renin-guided therapeutics and referral Referral Hypertension specialist 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. Aldosterone Antagonist Aldosterone Antagonist 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. Referral Hypertension specialist Referral Hypertension specialist Referral to a hypertension specialist Renin treatment-guided therapeutics Renin treatment-guided Therapeutics Renin treatment-guided therapeutics. A treatment algorithm is provided to guide treatment based upon renin levels.
- Primary Outcome Measures
Name Time Method blood pressure control four months Blood pressure control will be assessed according to guidelines established by American Heart Association.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
AnMed
🇺🇸Anderson, South Carolina, United States
Beaufort Jasper Hampton Comprehensive Health
🇺🇸Beaufort, South Carolina, United States
Carolina Medical Affiliates
🇺🇸Spartanburg, South Carolina, United States
Spartanburg Regional Health Services
🇺🇸Spartanburg, South Carolina, United States
McLeod Family Medicine Center
🇺🇸Florence, South Carolina, United States
Lovelace Family Medicine
🇺🇸Prosperity, South Carolina, United States
Family Diagnostics
🇺🇸Holly Hill, South Carolina, United States
Palmetto Primary Care
🇺🇸Summerville, South Carolina, United States