Mechanisms of Refractory Hypertension (Carvedilol)

Hypertensive Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02357004
• Other study ID #: A000502641
• Status: Withdrawn
• Phase: N/A
• Start date: February 2015
• Est. completion date: January 31, 2020

Study information

• Verified date: June 2020
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertensive

Intervention

Drug:
• Carvedilol
CR 40 mg daily in addition to normal BP medications
• Chlorthalidone
12.5 mg daily in addition to normal BP medications

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of subjects who achieve BP control (<140/90 mm Hg)	BP will be measured 8 weeks after starting carvedilol and after starting chlorthaidone. The percent of subjects with BP of <140/90 mm HG in each group will be reported.	8 weeks after baseline