Controlling Blood Pressure in Treatment Resistant Hypertension: A Pilot Study
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

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.
    

Intervention name(s): Renin treatment-guided Therapeutics; Referral Hypertension specialist; Aldosterone Antagonist
Intervention type(s): Drug; Other; Drug
Intervention description(s): Patients are treated based upon their renin levels according to an approved algorithm.; Patients are referred to a hypertension specialist.; Spironolactone 12.5 - 25mg daily
Intervention MeSH terms: Coal Tar; Mineralocorticoid Receptor Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypertension