An interventional study of Renin treatment-guided Therapeutics and Referral Hypertension specialist in Hypertension, sponsored by Medical University of South Carolina. Completed at 8 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-07-23.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
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.
Drug: Aldosterone Antagonist
Referral to a hypertension specialist
Other: Referral Hypertension specialist
Renin treatment-guided therapeutics. A treatment algorithm is provided to guide treatment based upon renin levels.
Drug: 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.
Drug: Renin treatment-guided Therapeutics · Other: Referral Hypertension specialist
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
blood pressure control
Blood pressure control will be assessed according to guidelines established by American Heart Association.
Time frame: four months
Plan to share: Yes — De-identified data file is available. Email Suparna Qanungo at MUSC.
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Medical University of South Carolina