Trial Outcomes & Findings for Blood Pressure in Dialysis Patients (NCT NCT01421771)
NCT ID: NCT01421771
Last Updated: 2023-11-30
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
126 participants
Primary outcome timeframe
one year
Results posted on
2023-11-30
Participant Flow
Participant milestones
| Measure |
Treatment to an Intensive BP Goal
Standardized predialysis systolic BP of 110-140 mmHg (intensive arm)
|
Treatment to Standard BP Goal
Standardized predialysis systolic BP of 155-165 mmHg (standard arm)
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
64
|
|
Overall Study
COMPLETED
|
62
|
64
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Blood Pressure in Dialysis Patients
Baseline characteristics by cohort
| Measure |
Treatment to an Intensive BP Goal
n=62 Participants
Treatment to a pre-dialysis standardized dialysis unit systolic blood pressure of 110-140 mm Hg
Antihypertensive Agents: Study formulary consists of ACE/ARB, Beta Adrenergic Blocker, Calcium Channel Blocker, vasodilators, peripheral alpha antagonist and central alpha agonist.
ACE I or ARB is first line, the order of addition of subsequent medications is per the discretion of the investigator
Dry weight Challenge: Reduce the estimated dry weight of the patient's progressively over 2 -week intervals until the dry weight challenge is no longer tolerated or the patient is at BP goal
Extend dialysis treatment time and re-challenge estimated dry weight: Extend dialysis treatment time and re-challenge estimated dry weight
|
Treatment to Standard BP Goal
n=64 Participants
Treatment to a pre-dialysis Standardized dialysis unit systolic BP of 155-165 mm Hg
Antihypertensive Agents: Study formulary consists of ACE/ARB, Beta Adrenergic Blocker, Calcium Channel Blocker, vasodilators, peripheral alpha antagonist and central alpha agonist.
ACE I or ARB is first line, the order of addition of subsequent medications is per the discretion of the investigator
Dry weight Challenge: Reduce the estimated dry weight of the patient's progressively over 2 -week intervals until the dry weight challenge is no longer tolerated or the patient is at BP goal
Extend dialysis treatment time and re-challenge estimated dry weight: Extend dialysis treatment time and re-challenge estimated dry weight
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
55 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
56 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 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
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
62 participants
n=5 Participants
|
64 participants
n=7 Participants
|
126 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: one yearOutcome measures
| Measure |
Treatment to an Intensive BP Goal
n=62 Participants
Standardized predialysis systolic BP of 110-140 mmHg (intensive arm)
|
Treatment to Standard BP Goal
n=64 Participants
Standardized predialysis systolic BP of 155-165 mmHg (standard arm)
|
|---|---|---|
|
Number of Participants Assessed for Intensive (110-140 mm Hg) and Standard (155-165mm Hg) Pre-dialysis Standardized BP Goal
|
62 participants
|
64 participants
|
SECONDARY outcome
Timeframe: One yearOutcome measures
| Measure |
Treatment to an Intensive BP Goal
n=62 Participants
Standardized predialysis systolic BP of 110-140 mmHg (intensive arm)
|
Treatment to Standard BP Goal
n=64 Participants
Standardized predialysis systolic BP of 155-165 mmHg (standard arm)
|
|---|---|---|
|
Number or Participants Assessed for Change in LV Mass
|
62 participants
|
64 participants
|
Adverse Events
Treatment to an Intensive BP Goal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment to Standard BP Goal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Samiha Mateen
University of New Mexico Health Sciences Center
Phone: 505-272-6057
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place