Controlling Blood Pressure in Treatment Resistant Hypertension: A Pilot Study

Completed · Not applicable

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT02167464

Run by

Medical University of South Carolina

People needed

70

Starts

2011-06-01

Expected to finish

2015-01-01

Last updated by the study team

2018-07-23

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• AnMed — Anderson, South Carolina, United States
• Beaufort Jasper Hampton Comprehensive Health — Beaufort, South Carolina, United States
• McLeod Family Medicine Center — Florence, South Carolina, United States
• Family Diagnostics — Holly Hill, South Carolina, United States
• Lovelace Family Medicine — Prosperity, South Carolina, United States
• Carolina Medical Affiliates — Spartanburg, South Carolina, United States
• Spartanburg Regional Health Services — Spartanburg, South Carolina, United States
• Palmetto Primary Care — Summerville, South Carolina, United States

Full record on ClinicalTrials.gov

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