TRH: Controlling Blood Pressure in Treatment Resistant Hypertension: A Pilot Study

• Sponsor: Medical University of South Carolina (Other)
• Overall Status: Completed
• CT.gov ID: NCT02167464
• Collaborator: University of South Carolina (Other)
• Enrollment: 70
• Locations: 8
• Arms: 4
• Duration (Months): 43
• Patients Per Site: 8.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Renin treatment-guided Therapeutics; Other: Referral Hypertension specialist; Drug: Aldosterone Antagonist	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: The PI was blinded to clinic and group assignment when he conducted the final statistical analysis.
• Primary Purpose: Treatment
• Official Title: Controlling Blood Pressure in Treatment Resistant Hypertension: A Pilot Study
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Aldosterone Antagonist; Spironolactone 12.5 - 25mg daily
Active Comparator: Referral Hypertension specialist Referral to a hypertension specialist	Other: Referral Hypertension specialist; Patients are referred to a hypertension specialist.
Active Comparator: Renin treatment-guided therapeutics Renin treatment-guided therapeutics. A treatment algorithm is provided to guide treatment based upon renin levels.	Drug: Renin treatment-guided Therapeutics; Patients are treated based upon their renin levels according to an approved algorithm.
Active Comparator: Renin-guided therapeutics and referral 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; Patients are treated based upon their renin levels according to an approved algorithm.; Other: Referral Hypertension specialist; Patients are referred to a hypertension specialist.

Outcome Measures

Primary Outcome Measures

1. blood pressure control [four months]

   Blood pressure control will be assessed according to guidelines established by American Heart Association.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AnMed	Anderson	South Carolina	United States	29621
2	Beaufort Jasper Hampton Comprehensive Health	Beaufort	South Carolina	United States	29935
3	McLeod Family Medicine Center	Florence	South Carolina	United States	29506
4	Family Diagnostics	Holly Hill	South Carolina	United States	29059
5	Lovelace Family Medicine	Prosperity	South Carolina	United States	29127
6	Carolina Medical Affiliates	Spartanburg	South Carolina	United States	29303
7	Spartanburg Regional Health Services	Spartanburg	South Carolina	United States	29303
8	Palmetto Primary Care	Summerville	South Carolina	United States	29485

Sponsors and Collaborators

• Medical University of South Carolina
• University of South Carolina

Investigators

• Principal Investigator: Marilyn A Laken, PhD, RN, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

• Laken MA, Dawson R, Engelman O, Lovelace O, Way C, Egan BM. Comparative effectiveness research in the "real" world: lessons learned in a study of treatment-resistant hypertension. J Am Soc Hypertens. 2013 Jan-Feb;7(1):95-101. doi: 10.1016/j.jash.2012.12.002. Review.

• Responsible Party: Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT02167464
• Other Study ID Numbers: R34HL105880
• First Posted: Jun 19, 2014
• Last Update Posted: Jul 23, 2018
• Last Verified: Sep 1, 2014

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Medical University of South Carolina: Hypertension
• Additional relevant MeSH terms: Hypertension; Coal Tar; Mineralocorticoid Receptor Antagonists

Study Results

No Results Posted as of Jul 23, 2018