Mechanisms of Refractory Hypertension (Carvedilol)
Information source: University of Alabama at Birmingham
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertensive
Intervention: Carvedilol (Drug); Chlorthalidone (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Alabama at Birmingham Official(s) and/or principal investigator(s): David A. Calhoun, MD, Principal Investigator, Affiliation: Cardiology Department - University of Alabama at Birmingham
Overall contact: Felice Cook, Phone: 205-934-1400, Email: fycook@uab.edu
Summary
The purpose of this protocol is test whether patients with hypertension refractory to
antihypertensive treatment have evidence of excessive sympathetic (i. e., nervous system)
activity.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: % of subjects who achieve BP control (<140/90 mm Hg)
Detailed description:
Refractory hypertension refers to high blood pressure that is failing conventional
antihypertensive therapies. In a retrospective assessment of such patients in our clinic we
observed that resting clinic heart rates were higher in patients with refractory
hypertension compared to patients with controlled hypertension. This observation has led to
the hypothesis that refractory hypertension is caused by excessive sympathetic output. This
protocol is designed to test this hypothesis by comparing the BP response to carvedilol
verses chlorthalidone in patients with refractory hypertension. If their extreme treatment
resistance is neurogenic is etiology, a significantly larger BP response to carvedilol
should occur compared to chlorthalidone.
Eligibility
Minimum age: 19 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Uncontrolled clinic BP (>140/90 mmHg)
- Receiving 5 or more antihypertensive agents including an ACE inhibitor or ARB,
calcium channel blocker, and chlorthalidone 25 mg
Exclusion Criteria:
- Current use of an alpha or beta or combined alpha-beta antagonist
- Known allergy to alpha-beta antagonists
- CKD (eGFR <40 ml/min/m2)
- MI, stroke or episode of CHF exacerbation within 3 months
- Bradycardia <50 bpm; history of 2nd or 3rd degree heart block unless treated by a
pacemaker
- Pregnant or breast-feeding women
- Known hypersensitivity to chlorthalidone or other sulfonamide-derived drugs
Locations and Contacts
Felice Cook, Phone: 205-934-1400, Email: fycook@uab.edu
David A. Calhoun, MD, Birmingham, Alabama 35294, United States; Recruiting David A. Calhoun, MD, Phone: 205-934-4633, Email: dcalhoun@uab.edu
Additional Information
Starting date: February 2015
Last updated: August 17, 2015
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