Mechanisms of Refractory Hypertension (Carvedilol)

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02357004

Enrollment

Registered

2015-02-06

Start date

2015-02-28

Completion date

2020-01-31

Last updated

2020-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertensive

Brief 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.

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.

Interventions

DRUGCarvedilol

CR 40 mg daily in addition to normal BP medications

DRUGChlorthalidone

12.5 mg daily in addition to normal BP medications

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
% of subjects who achieve BP control (<140/90 mm Hg)	8 weeks after baseline	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026