Trial Outcomes & Findings for Effect of ACE-inhibitors on Aortic Stiffness in Elderly Patients With Chronic Kidney Disease (NCT NCT00874432)
NCT ID: NCT00874432
Last Updated: 2020-10-27
Results Overview
PWV will be measured in patients over age 60 with stage 3 CKD and age matched controls without CKD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
up to 12 months
Results posted on
2020-10-27
Participant Flow
Recruitment occurred between January 2009 and May 2009. Patients were told about this study from the nephrologist or study coordinator around the time of their usual kidney clinic visit. Controls were enrolled through a group on campus who connects volunteers with research studies.
There is limited data for this study, the PI is now in private practice and some raw data no longer exists to answer this outcome. We have done our due diligence to populate this record with data that remains.
Participant milestones
| Measure |
Chronic Kidney Disease-ACE-I
ace inhibitor
lisinopril: 1 x 40 mg per day
|
Chronic Kidney Disease
angiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day
|
Age Matched Control-ACE-I
ace-inhibitor
lisinopril: 1 x 40 mg per day
|
Age Matched Control
Placebo
angiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
4
|
17
|
14
|
|
Overall Study
COMPLETED
|
5
|
2
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
8
|
3
|
Reasons for withdrawal
| Measure |
Chronic Kidney Disease-ACE-I
ace inhibitor
lisinopril: 1 x 40 mg per day
|
Chronic Kidney Disease
angiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day
|
Age Matched Control-ACE-I
ace-inhibitor
lisinopril: 1 x 40 mg per day
|
Age Matched Control
Placebo
angiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
|
Overall Study
Other
|
1
|
2
|
8
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Chronic Kidney Disease-ACE-I
n=8 Participants
ace inhibitor
lisinopril: 1 x 40 mg per day
|
Chronic Kidney Disease
n=4 Participants
angiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day
|
Age Matched Control-ACE-I
n=17 Participants
ace-inhibitor
lisinopril: 1 x 40 mg per day
|
Age Matched Control
n=14 Participants
Placebo
angiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65 years
n=8 Participants
|
87 years
n=4 Participants
|
63.4 years
n=17 Participants
|
67.3 years
n=14 Participants
|
68 years
n=43 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=8 Participants
|
1 Participants
n=4 Participants
|
13 Participants
n=17 Participants
|
11 Participants
n=14 Participants
|
28 Participants
n=43 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=8 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=17 Participants
|
3 Participants
n=14 Participants
|
15 Participants
n=43 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
8 participants
n=8 Participants
|
4 participants
n=4 Participants
|
17 participants
n=17 Participants
|
14 participants
n=14 Participants
|
43 participants
n=43 Participants
|
|
Serum Creatinine
|
1.3 mg/dL
STANDARD_DEVIATION 0.3 • n=8 Participants
|
0.8 mg/dL
STANDARD_DEVIATION 1.8 • n=4 Participants
|
NA mg/dL
STANDARD_DEVIATION NA • n=17 Participants
|
NA mg/dL
STANDARD_DEVIATION NA • n=14 Participants
|
NA mg/dL
STANDARD_DEVIATION NA • n=43 Participants
|
PRIMARY outcome
Timeframe: up to 12 monthsPopulation: Comparison of the baseline pulse wave velocity measures between the two groups (CKD vs no CKD) prior to intervention with ACE inhibitor. Data analyzed is from 32 participants due to drop out either from study self withdrawal (3) or ineligibility (1 = BP too low to start medication) and 7 without adequate testing data available for analysis.
PWV will be measured in patients over age 60 with stage 3 CKD and age matched controls without CKD.
Outcome measures
| Measure |
Chronic Kidney Disease
n=11 Participants
Participants over age 60 with Chronic Kidney Disease (CKD)
|
Age Matched Control
n=22 Participants
Healthy age-matched control over age 60
|
Age Matched Control-ACE-I
ace-inhibitor
lisinopril: 1 x 40 mg per day
|
Age Matched Control
Placebo
angiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day
|
|---|---|---|---|---|
|
Aortic Pulse Wave Velocity (PWV)
Carotid-Femoral Pulse Wave Velocity
|
9.90 m/s
Standard Deviation 1.12
|
9.96 m/s
Standard Deviation 2.52
|
—
|
—
|
|
Aortic Pulse Wave Velocity (PWV)
Carotid-Brachial Pulse Wave Velocity
|
7.62 m/s
Standard Deviation 1.76
|
8.57 m/s
Standard Deviation 1.46
|
—
|
—
|
|
Aortic Pulse Wave Velocity (PWV)
Carotid-Radial Pulse Wave Velocity
|
9.03 m/s
Standard Deviation 2.12
|
8.38 m/s
Standard Deviation 1.76
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and 12 monthsPopulation: Participants in each arm that had measurements for both baseline and 12 months
Comparison between Participants with Stage 3 Chronic Kidney Disease (CKD) and age matched Controls without CKD. The numbers reported are the mean of all the participants in the group at two points in time - the baseline and at 12 months for CFPWV, CBPWV, and CRPWV. Carotid-Femoral Pulse Wave Velocity (CFPWV) Carotid-Brachial Pulse Wave Velocity (CBPWV) Carotid-Radial Pulse Wave Velocity (CRPWV)
Outcome measures
| Measure |
Chronic Kidney Disease
n=5 Participants
Participants over age 60 with Chronic Kidney Disease (CKD)
|
Age Matched Control
n=1 Participants
Healthy age-matched control over age 60
|
Age Matched Control-ACE-I
n=10 Participants
ace-inhibitor
lisinopril: 1 x 40 mg per day
|
Age Matched Control
n=11 Participants
Placebo
angiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day
|
|---|---|---|---|---|
|
Mean Vascular Stiffness As Measured by PWV
CFPWV 12 months
|
11.07 m/s
Standard Deviation 2.29
|
10.66 m/s
Standard Deviation 2.78
|
8.33 m/s
Standard Deviation 1.06
|
9.79 m/s
Standard Deviation 1.97
|
|
Mean Vascular Stiffness As Measured by PWV
CFPWV Baseline
|
10.20 m/s
Standard Deviation 0.99
|
7.95 m/s
Standard Deviation NA
only one measurement
|
9.96 m/s
Standard Deviation 2.52
|
9.55 m/s
Standard Deviation 2.64
|
|
Mean Vascular Stiffness As Measured by PWV
CBPWV Baseline
|
7.87 m/s
Standard Deviation 1.70
|
6.28 m/s
Standard Deviation NA
only one measurement
|
9.14 m/s
Standard Deviation 0.82
|
8.17 m/s
Standard Deviation 1.61
|
|
Mean Vascular Stiffness As Measured by PWV
CBPWV 12 months
|
8.40 m/s
Standard Deviation 2.50
|
8.28 m/s
Standard Deviation 0.54
|
8.65 m/s
Standard Deviation 1.87
|
8.06 m/s
Standard Deviation 2.02
|
|
Mean Vascular Stiffness As Measured by PWV
CRPWV Baseline
|
9.03 m/s
Standard Deviation 0.93
|
4.80 m/s
Standard Deviation NA
only one measurement
|
9.75 m/s
Standard Deviation 0.95
|
8.95 m/s
Standard Deviation 1.69
|
|
Mean Vascular Stiffness As Measured by PWV
CRPWV 12 months
|
8.57 m/s
Standard Deviation 2.03
|
8.66 m/s
Standard Deviation 2.87
|
8.16 m/s
Standard Deviation 1.93
|
9.43 m/s
Standard Deviation 1.71
|
SECONDARY outcome
Timeframe: up to 12 monthsPopulation: There is limited data for this study, the PI is now in private practice and the raw data no longer exists to answer this outcome. We have done our due diligence to populate this record with data that remains.
Change in Blood Pressure will be used to measure the effect of ACE-inhibitors on the clinical markers of Cardiovascular Disease in participants with stage 3 CKD.
Outcome measures
Outcome data not reported
Adverse Events
Chronic Kidney Disease-ACE-I
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Chronic Kidney Disease
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Age Matched Control-ACE-I
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Age Matched Control
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Chronic Kidney Disease-ACE-I
n=8 participants at risk
ace inhibitor
lisinopril: 1 x 40 mg per day
|
Chronic Kidney Disease
n=4 participants at risk
angiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day
|
Age Matched Control-ACE-I
n=17 participants at risk
ace-inhibitor
lisinopril: 1 x 40 mg per day
|
Age Matched Control
n=14 participants at risk
Placebo
angiotensin converting enzyme inhibitor: Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dry Cough
|
0.00%
0/8 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
0.00%
0/4 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
5.9%
1/17 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
0.00%
0/14 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
|
Skin and subcutaneous tissue disorders
Uticaria
|
0.00%
0/8 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
25.0%
1/4 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
0.00%
0/17 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
0.00%
0/14 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
|
Nervous system disorders
Dizziness
|
25.0%
2/8 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
0.00%
0/4 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
0.00%
0/17 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
0.00%
0/14 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
|
Nervous system disorders
Lip Parasthesia
|
0.00%
0/8 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
0.00%
0/4 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
0.00%
0/17 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
7.1%
1/14 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
0.00%
0/4 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
0.00%
0/17 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
0.00%
0/14 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
|
General disorders
Headache
|
0.00%
0/8 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
0.00%
0/4 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
5.9%
1/17 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
0.00%
0/14 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
|
Musculoskeletal and connective tissue disorders
Stiff Neck
|
0.00%
0/8 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
0.00%
0/4 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
5.9%
1/17 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
0.00%
0/14 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
|
Vascular disorders
Low Blood Pressure
|
0.00%
0/8 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
0.00%
0/4 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
5.9%
1/17 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
0.00%
0/14 • up to 12 months
There is limited data for this study, the PI is now in private practice and unreachable. The remaining study team has found data only in support of Aim 1 (CKD aortic stiffness vs healthy controls), no data for ACE-I arms.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place