MedTrace Logo

Controlling Blood Pressure in Treatment Resistant Hypertension: A Pilot Study

NCT02167464 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2018-07-23

No results posted yet for this study

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.

Conditions

Interventions

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.

DRUG

Aldosterone Antagonist

Spironolactone 12.5 - 25mg daily

Sponsors & Collaborators

  • University of South Carolina

    collaborator OTHER

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Marilyn A Laken, PhD, RN · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02167464 on ClinicalTrials.gov