Mechanisms of Refractory Hypertension (Carvedilol)

NCT02357004 | Withdrawn

• 1 other identifier: A000502641
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertensive

Outcome Measures

Primary Outcomes (1)

• % 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

Study Arms (2)

Carvedilol

EXPERIMENTAL

Carvedilol CR 40 mg daily in addition to their normal BP medications. Subjects will be seen in follow-up at 2-week intervals for the duration of the 8-week intervention period. If the clinic BP remains elevated (\>140/90 mmHg) at any of the follow-up visits, the study medication will be titrated up to carvedilol CR 80 mg daily (subjects will take 2 of the study pills).

Drug: Carvedilol

Chlorthalidone

EXPERIMENTAL

Chlorthalidone 12.5 mg daily in addition to their normal BP medications. Subjects will be seen in follow-up at 2-week intervals for the duration of the 8-week intervention period. If the clinic BP remains elevated (\>140/90 mmHg) at any of the follow-up visits, the study medication will be titrated up to chlorthalidone 25 mg daily (subjects will take 2 of the study pills).

Drug: Chlorthalidone

Interventions

Carvedilol DRUG

CR 40 mg daily in addition to normal BP medications

Carvedilol

Chlorthalidone DRUG

12.5 mg daily in addition to normal BP medications

Chlorthalidone

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

MeSH Terms

Interventions

Carvedilol; Chlorthalidone

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzophenones; Phthalimides; Imides; Ketones; Sulfones; Sulfur Compounds; Isoindoles

Study Officials

• David A. Calhoun, MD

  Cardiology Department - University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: February 6, 2015
• Study Start: February 1, 2015
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: June 12, 2020

Record last verified: 2020-06