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

NCT00638222 | Terminated Results DMC

• 1 other identifier: UTHSC-08
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Vascular Disease; Kidney Disease

Keywords

Carvedilol; Heart Disease; Vascular Disease; Kidney

Outcome Measures

Primary Outcomes (1)

• Micro T- Wave Alternans

  week 1, 8, 11, 18

Secondary Outcomes (6)

• Oxidized LDL

  week 1, 8, 11, 18

• Interleukin-6

  week 1, 8, 11, 18

• Plasma C-reactive Protein

  week 1, 8, 11, 18

• Plasma Cardiac Troponin T

  week 1, 8, 11, 18

• Plasma NT-pro BNP

  week 1, 8, 11, 18

Study Arms (1)

All Study Participants

ACTIVE COMPARATOR

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.

Other: Carvedilol and Placebo

Interventions

Carvedilol and Placebo OTHER

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.

All Study Participants

Eligibility Criteria

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

You may qualify if:

• Adults age 18 and older
• Chronic kidney disease
• Must be able to do stress test

You may not qualify if:

• 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 β-blocker medication at the time of enrollment
• Known history of asthma exacerbation with β-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

Sponsors & Collaborators

• University of Toledo Health Science Campus: lead
• GlaxoSmithKline: collaborator

Study Sites (2)

University of Toledo, Health Science Campus

Toledo, Ohio, 43606, United States

Location

Site Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Vascular Diseases; Kidney Diseases; Heart Diseases

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

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

Limitations and Caveats

Early termination due to poor enrollment leading to small number of subjects to be analyzed.

Results Point of Contact

• Title: Christopher Cooper, MD
• Organization: The University of Toledo, HSC

christopher.cooper@utoledo.edu

419.383.6030

Study Officials

• Christopher Cooper,, MD

  University of Toledo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Interim Chair/Dir Cardiovas Research Cntr

Study Record Dates

• First Submitted: March 5, 2008
• First Posted: March 19, 2008
• Study Start: May 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: November 13, 2014
• Results First Posted: November 13, 2014

Record last verified: 2014-11

Locations

US (2)