Controlling Blood Pressure in Treatment Resistant Hypertension: A Pilot Study

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Collaborator: University of South Carolina
• Treatments: Coal Tar; Mineralocorticoid Receptor Antagonists; Spironolactone

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.