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Trial record 80 of 221 for:    Aldosterone

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02167464
Recruitment Status : Completed
First Posted : June 19, 2014
Last Update Posted : July 23, 2018
Sponsor:
Collaborator:
University of South Carolina
Information provided by (Responsible Party):
Medical University of South Carolina

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
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 : June 2011
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Coal Tar

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.




Primary Outcome Measures :
  1. blood pressure control [ Time Frame: four months ]
    Blood pressure control will be assessed according to guidelines established by American Heart Association.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02167464


Locations
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United States, South Carolina
AnMed
Anderson, South Carolina, United States, 29621
Beaufort Jasper Hampton Comprehensive Health
Beaufort, South Carolina, United States, 29935
McLeod Family Medicine Center
Florence, South Carolina, United States, 29506
Family Diagnostics
Holly Hill, South Carolina, United States, 29059
Lovelace Family Medicine
Prosperity, South Carolina, United States, 29127
Carolina Medical Affiliates
Spartanburg, South Carolina, United States, 29303
Spartanburg Regional Health Services
Spartanburg, South Carolina, United States, 29303
Palmetto Primary Care
Summerville, South Carolina, United States, 29485
Sponsors and Collaborators
Medical University of South Carolina
University of South Carolina
Investigators
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Principal Investigator: Marilyn A Laken, PhD, RN Medical University of South Carolina

Publications of Results:
Other Publications:
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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02167464     History of Changes
Other Study ID Numbers: R34HL105880 ( U.S. NIH Grant/Contract )
First Posted: June 19, 2014    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: September 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data file is available. Email Suparna Qanungo at MUSC.

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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:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Coal Tar
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Keratolytic Agents
Dermatologic Agents