Kidney Disease, Vascular Disease
Conditions
Keywords
Carvedilol, Heart Disease, Vascular Disease, Kidney
Brief summary
Evaluate effectiveness of Carvedilol CR on Micro T-Wave Alternans in high risk hypertensives
Detailed 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.
Interventions
OTHERCarvedilol 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.
Sponsors
GlaxoSmithKline
University of Toledo Health Science Campus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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 * 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Micro T- Wave Alternans | week 1, 8, 11, 18 |
Secondary
| Measure | Time frame |
|---|---|
| Interleukin-6 | week 1, 8, 11, 18 |
| Plasma C-reactive Protein | week 1, 8, 11, 18 |
| Oxidized LDL | week 1, 8, 11, 18 |
| Plasma NT-pro BNP | week 1, 8, 11, 18 |
| Plasma F2-isoprostanes | week 1, 8, 11, 18 |
| Plasma Cardiac Troponin T | week 1, 8, 11, 18 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Carvedilol Then Placebo Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.
Carvedilol: Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following. | 0 |
| Placebo Then Study Drug Subjects will receive placebo for 8 weeks then be given study drug for 8 more.
Placebo: Subjects will receive placebo for 8 weeks then be given study drug for 8 more. | 0 |
| All Study Participants 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 | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | All Study Participants | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 participants | 0 participants |
| Age, Categorical >=65 years | 2 participants | 2 participants |
| Age, Categorical Between 18 and 65 years | 4 participants | 4 participants |
| Age, Continuous | 55 years STANDARD_DEVIATION 15 | 55 years STANDARD_DEVIATION 15 |
| Gender Female | 0 participants | 0 participants |
| Gender Male | 6 participants | 6 participants |
| Region of Enrollment United States | 6 participants | 6 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 6 / 6 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 2 / 6 |
Outcome results
Primary
Micro T- Wave Alternans
Time frame: week 1, 8, 11, 18
Secondary
Interleukin-6
Time frame: week 1, 8, 11, 18
Secondary
Oxidized LDL
Time frame: week 1, 8, 11, 18
Secondary
Plasma Cardiac Troponin T
Time frame: week 1, 8, 11, 18
Secondary
Plasma C-reactive Protein
Time frame: week 1, 8, 11, 18
Secondary
Plasma F2-isoprostanes
Time frame: week 1, 8, 11, 18
Secondary
Plasma NT-pro BNP
Time frame: week 1, 8, 11, 18