Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mechanisms of Refractory Hypertension (Carvedilol)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02357004
Recruitment Status : Withdrawn (Change in priority of interventional protocols)
First Posted : February 6, 2015
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
David Calhoun, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE January 22, 2015
First Posted Date  ICMJE February 6, 2015
Last Update Posted Date June 12, 2020
Study Start Date  ICMJE February 2015
Actual Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2015)
% of subjects who achieve BP control (<140/90 mm Hg) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mechanisms of Refractory Hypertension (Carvedilol)
Official Title  ICMJE Not Provided
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypertensive
Intervention  ICMJE
  • Drug: Carvedilol
    CR 40 mg daily in addition to normal BP medications
  • Drug: Chlorthalidone
    12.5 mg daily in addition to normal BP medications
Study Arms  ICMJE
  • Experimental: Carvedilol
    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).
    Intervention: Drug: Carvedilol
  • Experimental: Chlorthalidone
    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).
    Intervention: Drug: Chlorthalidone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 10, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 2, 2015)
100
Estimated Study Completion Date  ICMJE January 31, 2020
Actual Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT02357004
Other Study ID Numbers  ICMJE A000502641
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Calhoun, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David A. Calhoun, MD Cardiology Department - University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP