Trial Outcomes & Findings for Mechanisms and Treatment of Intradialytic Hypertension (NCT NCT00827775)
NCT ID: NCT00827775
Last Updated: 2020-11-03
Results Overview
1. ALDH bright cells reported as percentage of mononuclear cells. These were assayed using flow cytometry 2. CD34/CD133 endothelial progenitor cells reported as percentage of mononuclear cells. These were assayed using flow cytometry
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
55 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-11-03
Participant Flow
Participant milestones
| Measure |
Control
Patients without intradialytic hypertension defined as average pre to post hemodialysis SBP falling \>10 mmhg for more than 4/6 of the last dialysis treatment sessions
|
Intervention
Patients with intradialytic hypertension defined as average pre to post hemodialysis SBP elevation of \>10 mmhg for more than 4/6 of the last dialysis treatment sessions
Carvedilol: Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
30
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
Reasons for withdrawal
| Measure |
Control
Patients without intradialytic hypertension defined as average pre to post hemodialysis SBP falling \>10 mmhg for more than 4/6 of the last dialysis treatment sessions
|
Intervention
Patients with intradialytic hypertension defined as average pre to post hemodialysis SBP elevation of \>10 mmhg for more than 4/6 of the last dialysis treatment sessions
Carvedilol: Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
5
|
Baseline Characteristics
Mechanisms and Treatment of Intradialytic Hypertension
Baseline characteristics by cohort
| Measure |
Control
n=25 Participants
Patients without intradialytic hypertension defined as average pre to post hemodialysis SBP falling \>10 mmhg for more than 4/6 of the last dialysis treatment sessions
|
Intervention
n=25 Participants
Patients with intradialytic hypertension defined as average pre to post hemodialysis SBP elevation of \>10 mmhg for more than 4/6 of the last dialysis treatment sessions
Carvedilol: Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
53.9 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
54.5 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Follow up measurements were only obtained in the intervention subjects receiving carvedilol
1. ALDH bright cells reported as percentage of mononuclear cells. These were assayed using flow cytometry 2. CD34/CD133 endothelial progenitor cells reported as percentage of mononuclear cells. These were assayed using flow cytometry
Outcome measures
| Measure |
Control
n=25 Participants
Patients without intradialytic hypertension defined as average pre to post hemodialysis SBP falling \>10 mmhg for more than 4/6 of the last dialysis treatment sessions
|
Intervention
n=25 Participants
Patients with intradialytic hypertension defined as average pre to post hemodialysis SBP elevation of \>10 mmhg for more than 4/6 of the last dialysis treatment sessions
Carvedilol: Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid
|
|---|---|---|
|
Endothelial Progenitor Cells
Baseline ALDH bright
|
0.052 % of mononuclear cells
Interval 0.042 to 0.076
|
0.034 % of mononuclear cells
Interval 0.017 to 0.08
|
|
Endothelial Progenitor Cells
Follow up ALDH bright
|
—
|
0.027 % of mononuclear cells
Interval 0.013 to 0.048
|
|
Endothelial Progenitor Cells
Baseline CD34/CD133 endothelial progenitor cells
|
0.059 % of mononuclear cells
Interval 0.036 to 0.07
|
0.033 % of mononuclear cells
Interval 0.016 to 0.051
|
|
Endothelial Progenitor Cells
Follow up CD34/CD133
|
—
|
0.029 % of mononuclear cells
Interval 0.019 to 0.049
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Follow up measurements were only obtained in intervention subjects receiving carvedilol
Measured as percent change in brachial artery diameter from baseline to post shear stress for an individual measurement. Follow up measurements were obtained in intervention subjects 12 weeks later
Outcome measures
| Measure |
Control
n=25 Participants
Patients without intradialytic hypertension defined as average pre to post hemodialysis SBP falling \>10 mmhg for more than 4/6 of the last dialysis treatment sessions
|
Intervention
n=25 Participants
Patients with intradialytic hypertension defined as average pre to post hemodialysis SBP elevation of \>10 mmhg for more than 4/6 of the last dialysis treatment sessions
Carvedilol: Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid
|
|---|---|---|
|
Flow Mediated Vasodilation
Baseline FMD
|
1.67 % dilation from baseline
Standard Deviation 1.24
|
1.03 % dilation from baseline
Standard Deviation 0.7
|
|
Flow Mediated Vasodilation
Follow Up FMD
|
—
|
1.4 % dilation from baseline
Standard Deviation 0.84
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control
n=25 participants at risk
Patients without intradialytic hypertension defined as average pre to post hemodialysis SBP falling \>10 mmhg for more than 4/6 of the last dialysis treatment sessions
|
Intervention
n=25 participants at risk
Patients with intradialytic hypertension defined as average pre to post hemodialysis SBP elevation of \>10 mmhg for more than 4/6 of the last dialysis treatment sessions
Carvedilol: Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid
|
|---|---|---|
|
Gastrointestinal disorders
Gastroparesis
|
0.00%
0/25 • First day of enrollment to end of study, an average 12 weeks
|
4.0%
1/25 • Number of events 1 • First day of enrollment to end of study, an average 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/25 • First day of enrollment to end of study, an average 12 weeks
|
4.0%
1/25 • Number of events 1 • First day of enrollment to end of study, an average 12 weeks
|
|
Vascular disorders
Hemodialysis Access Revision
|
0.00%
0/25 • First day of enrollment to end of study, an average 12 weeks
|
4.0%
1/25 • Number of events 1 • First day of enrollment to end of study, an average 12 weeks
|
|
Cardiac disorders
Fluid Overload
|
0.00%
0/25 • First day of enrollment to end of study, an average 12 weeks
|
8.0%
2/25 • Number of events 2 • First day of enrollment to end of study, an average 12 weeks
|
Other adverse events
| Measure |
Control
n=25 participants at risk
Patients without intradialytic hypertension defined as average pre to post hemodialysis SBP falling \>10 mmhg for more than 4/6 of the last dialysis treatment sessions
|
Intervention
n=25 participants at risk
Patients with intradialytic hypertension defined as average pre to post hemodialysis SBP elevation of \>10 mmhg for more than 4/6 of the last dialysis treatment sessions
Carvedilol: Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid
|
|---|---|---|
|
Cardiac disorders
Symptomatic Intradialytic Hypotension
|
0.00%
0/25 • First day of enrollment to end of study, an average 12 weeks
|
88.0%
22/25 • Number of events 22 • First day of enrollment to end of study, an average 12 weeks
|
Additional Information
Peter Van Buren
University of Texas Southwestern Medical Center
Phone: 214-645-8293
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place