Carvedilol and Micro T-Wave Alternans in Hypertensives With Chronic Kidney Disease

Kidney Disease Clinical Trial

Official title:

Carvedilol and Micro T-Wave Alternans in Hypertensives With Chronic Kidney Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00638222
• Other study ID #: UTHSC-08
• Status: Terminated
• Phase: N/A
• First received: March 5, 2008
• Last updated: November 5, 2014
• Start date: May 2008
• Est. completion date: December 2010

Study information

• Verified date: November 2014
• Source: University of Toledo Health Science Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Evaluate effectiveness of Carvedilol CR on Micro T-Wave Alternans in high risk hypertensives

Description:

The effect of Carvedilol CR on Micro T-Wave Alternans will be assessed in 30 hypertensives with stage 4 or 5 chronic kidney disease utilizing a cross-over design and contrasting no treatment against active treatment periods of 8 weeks.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults age 18 and older

• Chronic kidney disease

• Must be able to do stress test

Exclusion Criteria:

• Must not be mentally disabled

• Unable to provide informed consent

• Unable or unwilling to comply with study protocol or procedures

• Pregnancy or unknown pregnancy status in female of childbearing potential

• Participation in any drug trial during the study period

• Prior enrollment in this study

• Active liver disease

• Currently on ß-blocker medication at the time of enrollment

• Known history of asthma exacerbation with ß-blocker therapy

• Second or third degree AV nodal block or bradycardia with resting heart rate <50 bpm

• Prior allograft organ transplantation

• Planned allograft transplantation reasonably foreseen within the active treatment period

• Electrocardiographic left or right bundle branch block

• Permanent implanted pacemaker

• Atrial fibrillation

• Ongoing treatment with any of the following medications: sotalol (Betapace), azimilide (Stedicor), quinidine (Quinidex), disopyramide (Norpace), dofetilide (Tikosyn), ibutilide (Corvert), procainamide (Procanbid), bepridil (Vascor), amiodarone (Cordarone), clarithromycin (Biaxin), erythromycin (Eryc), halofantrine (Halfan), pentamidine (Pentam), sparfloxacin (Zagam), domperidone (Motilium), droperidol (Inapsine), chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil), thioridazine (Mellaril), pimozide (Orap), arsenic trioxide (Trisenox), cisapride (Propulsid), lidoflazine (Clinium), and methadone (Dolophine)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic
• Vascular Disease
• Vascular Diseases

Intervention

Other:
• Carvedilol and Placebo
All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately.

Locations

Country	Name	City	State
United States	Site Rhode Island Hospital	Providence	Rhode Island
United States	University of Toledo, Health Science Campus	Toledo	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Toledo Health Science Campus	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Micro T- Wave Alternans		week 1, 8, 11, 18	No
Secondary	Oxidized LDL		week 1, 8, 11, 18	No
Secondary	Interleukin-6		week 1, 8, 11, 18	No
Secondary	Plasma C-reactive Protein		week 1, 8, 11, 18	No
Secondary	Plasma Cardiac Troponin T		week 1, 8, 11, 18	No
Secondary	Plasma NT-pro BNP		week 1, 8, 11, 18	No
Secondary	Plasma F2-isoprostanes		week 1, 8, 11, 18	No