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

July 19, 2018 updated by: Medical University of South Carolina
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed
      • Beaufort, South Carolina, United States, 29935
        • Beaufort Jasper Hampton Comprehensive Health
      • Florence, South Carolina, United States, 29506
        • McLeod Family Medicine Center
      • Holly Hill, South Carolina, United States, 29059
        • Family Diagnostics
      • Prosperity, South Carolina, United States, 29127
        • Lovelace Family Medicine
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Regional Health Services
      • Spartanburg, South Carolina, United States, 29303
        • Carolina Medical Affiliates
      • Summerville, South Carolina, United States, 29485
        • Palmetto Primary Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
Other: Referral Hypertension specialist
Patients are referred to a hypertension specialist.
Drug: Renin treatment-guided Therapeutics
Patients are treated based upon their renin levels according to an approved algorithm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood pressure control
Time Frame: four months
Blood pressure control will be assessed according to guidelines established by American Heart Association.
four months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

University of South Carolina

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

June 17, 2014

First Submitted That Met QC Criteria

June 18, 2014

First Posted (Estimate)

June 19, 2014

Study Record Updates

Last Update Posted (Actual)

July 23, 2018

Last Update Submitted That Met QC Criteria

July 19, 2018

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R34HL105880 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data file is available. Email Suparna Qanungo at MUSC.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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