Mechanism of Masked Hypertension - Intervention

• Status: Withdrawn
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

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 activity than non-sympatholytic antihypertensive medication (dihydropyridine calcium channel blocker - amlodipine) in individuals with masked hypertension.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Amlodipine; Carvedilol

Criteria

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