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Status:

WITHDRAWN

Mechanism of Masked Hypertension - Intervention

Lead Sponsor:

University of Alabama at Birmingham

Conditions:

Masked Hypertension

Eligibility:

All Genders

18-75 years

Phase:

PHASE3

Brief Summary

To test the hypothesis that sympatholytic antihypertensive antihypertensive therapy (αβ-blocker - carvedilol) will reduce out-of-clinic ambulatory BP to a greater extent by blocking sympathetic activi...

Detailed Description

A. Participants. Study participants with masked hypertension (MH) with controlled clinic BP (\< 130/80 mmHg) and uncontrolled out-of-clinic awake ambulatory BP (ABP ≥ 130/80 mmHg) untreated with antih...

Eligibility Criteria

Inclusion

  • Study participants with masked hypertension i.e. controlled clinic blood pressure (BP) and uncontrolled out-of-clinic awake ambulatory BP will be enrolled.
  • A. Inclusion criteria.
  • Adults (18-75 years of age)
  • Controlled clinic BP (\< 130/80 mmHg) untreated with antihypertensive medications
  • Uncontrolled awake ambulatory BP (≥ 130/80 mmHg) untreated with antihypertensive medications
  • B. Exclusion criteria.
  • Hypertensive (Clinic BP ≥ 130/80 mmHg)
  • Hypotensive (Clinic BP \< 90/70 mmHg)
  • Bradycardic (Heart rate \< 60 beats/minute)
  • Heart block
  • Use of an antihypertensive medication within the last 3 months
  • Use of an steroid containing medications within the last 3 months
  • Body mass index ≥ 30 Kg/m2
  • Chronic kidney disease (Estimated GFR \< 60 mL/min/1.73m2)
  • Primary aldosteronism
  • Renal artery stenosis
  • Pheochromocytoma
  • Diabetes mellitus
  • Pregnant women
  • Breast feeding women
  • Dementia and/or cognitive impairment prohibiting consent
  • History of stroke within the past 6 months
  • History of unstable angina within the past 6 months
  • History of myocardial infarction within the past 6 months
  • Allergy or intolerance to β-blockers
  • Allergy or intolerance to calcium channel blockers

Exclusion

    Key Trial Info

    Start Date :

    July 1 2021

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2026

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT04121299

    Start Date

    July 1 2021

    End Date

    June 1 2026

    Last Update

    November 5 2021

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Hypertension Research Clinic at UAB

    Birmingham, Alabama, United States, 35294