Trial Outcomes & Findings for Telmisartan Plus Exercise to Improve Functioning in Peripheral Artery Disease (NCT NCT02593110)
NCT ID: NCT02593110
Last Updated: 2023-01-11
Results Overview
We will determine whether telmisartan therapy with or without exercise improves six-minute walk distance at 6-month follow-up, compared to placebo with or without exercise (i.e. two group comparisons of all participants randomized to telmisartan vs. all participants randomized to placebo).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
114 participants
Primary outcome timeframe
Change from baseline to six-month follow-up
Results posted on
2023-01-11
Participant Flow
Participant milestones
| Measure |
Telmisartan + Supervised Treadmill Exercise Therapy
Participants in this group will receive both daily telmisartan and supervised treadmill exercise three days weekly for six months.
Supervised Treadmill Exercise Therapy: Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.
Telmisartan: Participants randomized to the telmisartan arm of the study will take 20 mg or 40 mg of telmisartan daily based on the results of their study run-in. Participants will have their dose increased to up to 80 mg as tolerated.
|
Telmisartan + "No Exercise" Control Group
Participants in this group will receive daily telmisartan and attend weekly educational lectures at the medical center for six months.
Telmisartan: Participants randomized to the telmisartan arm of the study will take 20 mg or 40 mg of telmisartan daily based on the results of their study run-in. Participants will have their dose increased to up to 80 mg as tolerated.
"No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.
|
Placebo + Supervised Treadmill Exercise Therapy
Participants randomized to this group will receive daily placebo and supervised treadmill exercise three times weekly for six months.
Supervised Treadmill Exercise Therapy: Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.
Placebo
|
Placebo + "No Exercise" Control Group
Participants randomized to this group will receive daily placebo and health education lectures weekly for six months.
"No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.
Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
29
|
28
|
27
|
|
Overall Study
COMPLETED
|
30
|
26
|
24
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
4
|
2
|
Reasons for withdrawal
| Measure |
Telmisartan + Supervised Treadmill Exercise Therapy
Participants in this group will receive both daily telmisartan and supervised treadmill exercise three days weekly for six months.
Supervised Treadmill Exercise Therapy: Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.
Telmisartan: Participants randomized to the telmisartan arm of the study will take 20 mg or 40 mg of telmisartan daily based on the results of their study run-in. Participants will have their dose increased to up to 80 mg as tolerated.
|
Telmisartan + "No Exercise" Control Group
Participants in this group will receive daily telmisartan and attend weekly educational lectures at the medical center for six months.
Telmisartan: Participants randomized to the telmisartan arm of the study will take 20 mg or 40 mg of telmisartan daily based on the results of their study run-in. Participants will have their dose increased to up to 80 mg as tolerated.
"No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.
|
Placebo + Supervised Treadmill Exercise Therapy
Participants randomized to this group will receive daily placebo and supervised treadmill exercise three times weekly for six months.
Supervised Treadmill Exercise Therapy: Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.
Placebo
|
Placebo + "No Exercise" Control Group
Participants randomized to this group will receive daily placebo and health education lectures weekly for six months.
"No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.
Placebo
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
3
|
2
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Telmisartan Plus Exercise to Improve Functioning in Peripheral Artery Disease
Baseline characteristics by cohort
| Measure |
Telmisartan + Supervised Treadmill Exercise Therapy
n=30 Participants
Participants in this group will receive both daily telmisartan and supervised treadmill exercise three days weekly for six months.
Supervised Treadmill Exercise Therapy: Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.
Telmisartan: Participants randomized to the telmisartan arm of the study will take 20 mg or 40 mg of telmisartan daily based on the results of their study run-in. Participants will have their dose increased to up to 80 mg as tolerated.
|
Telmisartan + "No Exercise" Control Group
n=29 Participants
Participants in this group will receive daily telmisartan and attend weekly educational lectures at the medical center for six months.
Telmisartan: Participants randomized to the telmisartan arm of the study will take 20 mg or 40 mg of telmisartan daily based on the results of their study run-in. Participants will have their dose increased to up to 80 mg as tolerated.
"No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.
|
Placebo + Supervised Treadmill Exercise Therapy
n=28 Participants
Participants randomized to this group will receive daily placebo and supervised treadmill exercise three times weekly for six months.
Supervised Treadmill Exercise Therapy: Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.
Placebo
|
Placebo + "No Exercise" Control Group
n=27 Participants
Participants randomized to this group will receive daily placebo and health education lectures weekly for six months.
"No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.
Placebo
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Ankle-brachial index
|
0.67 ratio
STANDARD_DEVIATION 0.23 • n=5 Participants
|
0.77 ratio
STANDARD_DEVIATION 0.30 • n=7 Participants
|
0.78 ratio
STANDARD_DEVIATION 0.23 • n=5 Participants
|
0.69 ratio
STANDARD_DEVIATION 0.17 • n=4 Participants
|
0.73 ratio
STANDARD_DEVIATION 0.24 • n=21 Participants
|
|
Age, Continuous
|
68.5 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
66.9 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
65.8 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
67.9 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
67.3 years
STANDARD_DEVIATION 9.9 • n=21 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
102 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Body mass index
|
30.45 kg/m^2
STANDARD_DEVIATION 7.49 • n=5 Participants
|
27.61 kg/m^2
STANDARD_DEVIATION 6.23 • n=7 Participants
|
28.73 kg/m^2
STANDARD_DEVIATION 6.40 • n=5 Participants
|
28.20 kg/m^2
STANDARD_DEVIATION 5.75 • n=4 Participants
|
28.77 kg/m^2
STANDARD_DEVIATION 6.53 • n=21 Participants
|
|
Six-min walk distance
|
327.30 meters
STANDARD_DEVIATION 96.58 • n=5 Participants
|
359.62 meters
STANDARD_DEVIATION 84.41 • n=7 Participants
|
317.42 meters
STANDARD_DEVIATION 123.31 • n=5 Participants
|
374.55 meters
STANDARD_DEVIATION 122.40 • n=4 Participants
|
344.29 meters
STANDARD_DEVIATION 108.51 • n=21 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to six-month follow-upWe will determine whether telmisartan therapy with or without exercise improves six-minute walk distance at 6-month follow-up, compared to placebo with or without exercise (i.e. two group comparisons of all participants randomized to telmisartan vs. all participants randomized to placebo).
Outcome measures
| Measure |
Telmisartan + Supervised Treadmill Exercise Therapy
n=30 Participants
Participants in this group will receive both daily telmisartan and supervised treadmill exercise three days weekly for six months.
Supervised Treadmill Exercise Therapy: Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.
Telmisartan: Participants randomized to the telmisartan arm of the study will take 20 mg or 40 mg of telmisartan daily based on the results of their study run-in. Participants will have their dose increased to up to 80 mg as tolerated.
|
Telmisartan + "No Exercise" Control Group
n=25 Participants
Participants in this group will receive daily telmisartan and attend weekly educational lectures at the medical center for six months.
Telmisartan: Participants randomized to the telmisartan arm of the study will take 20 mg or 40 mg of telmisartan daily based on the results of their study run-in. Participants will have their dose increased to up to 80 mg as tolerated.
"No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.
|
Placebo + Supervised Treadmill Exercise Therapy
n=23 Participants
Participants randomized to this group will receive daily placebo and supervised treadmill exercise three times weekly for six months.
Supervised Treadmill Exercise Therapy: Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.
Placebo
|
Placebo + "No Exercise" Control Group
n=24 Participants
Participants randomized to this group will receive daily placebo and health education lectures weekly for six months.
"No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.
Placebo
|
|---|---|---|---|---|
|
Six-minute Walk Performance
|
5.86 meters
Standard Deviation 67.21
|
-3.92 meters
Standard Deviation 47.33
|
30.27 meters
Standard Deviation 29.44
|
-4.62 meters
Standard Deviation 42.54
|
SECONDARY outcome
Timeframe: Change from baseline to six-month follow-upIn the treadmill walking test, participants walk on either a gardner or modified gardner protocol until they stop the test. Distance walked is recorded.
Outcome measures
| Measure |
Telmisartan + Supervised Treadmill Exercise Therapy
n=26 Participants
Participants in this group will receive both daily telmisartan and supervised treadmill exercise three days weekly for six months.
Supervised Treadmill Exercise Therapy: Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.
Telmisartan: Participants randomized to the telmisartan arm of the study will take 20 mg or 40 mg of telmisartan daily based on the results of their study run-in. Participants will have their dose increased to up to 80 mg as tolerated.
|
Telmisartan + "No Exercise" Control Group
n=24 Participants
Participants in this group will receive daily telmisartan and attend weekly educational lectures at the medical center for six months.
Telmisartan: Participants randomized to the telmisartan arm of the study will take 20 mg or 40 mg of telmisartan daily based on the results of their study run-in. Participants will have their dose increased to up to 80 mg as tolerated.
"No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.
|
Placebo + Supervised Treadmill Exercise Therapy
n=19 Participants
Participants randomized to this group will receive daily placebo and supervised treadmill exercise three times weekly for six months.
Supervised Treadmill Exercise Therapy: Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.
Placebo
|
Placebo + "No Exercise" Control Group
n=20 Participants
Participants randomized to this group will receive daily placebo and health education lectures weekly for six months.
"No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.
Placebo
|
|---|---|---|---|---|
|
Maximal Treadmill Walking Distance
|
207.99 meters
Standard Deviation 150.44
|
66.21 meters
Standard Deviation 226.81
|
176.64 meters
Standard Deviation 259.51
|
80.96 meters
Standard Deviation 178.73
|
SECONDARY outcome
Timeframe: Change from baseline to six-month follow-upThe WIQ is a well validated questionnaire that measures patient-reported walking limitations in distance and speed and stair-climbing. They are scored on a 0-100 scale and that 100 indicates the best possible score.
Outcome measures
| Measure |
Telmisartan + Supervised Treadmill Exercise Therapy
n=29 Participants
Participants in this group will receive both daily telmisartan and supervised treadmill exercise three days weekly for six months.
Supervised Treadmill Exercise Therapy: Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.
Telmisartan: Participants randomized to the telmisartan arm of the study will take 20 mg or 40 mg of telmisartan daily based on the results of their study run-in. Participants will have their dose increased to up to 80 mg as tolerated.
|
Telmisartan + "No Exercise" Control Group
n=26 Participants
Participants in this group will receive daily telmisartan and attend weekly educational lectures at the medical center for six months.
Telmisartan: Participants randomized to the telmisartan arm of the study will take 20 mg or 40 mg of telmisartan daily based on the results of their study run-in. Participants will have their dose increased to up to 80 mg as tolerated.
"No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.
|
Placebo + Supervised Treadmill Exercise Therapy
n=24 Participants
Participants randomized to this group will receive daily placebo and supervised treadmill exercise three times weekly for six months.
Supervised Treadmill Exercise Therapy: Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.
Placebo
|
Placebo + "No Exercise" Control Group
n=24 Participants
Participants randomized to this group will receive daily placebo and health education lectures weekly for six months.
"No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.
Placebo
|
|---|---|---|---|---|
|
Walking Impairment Questionnaire (WIQ) Distance Score
|
8.77 score on a scale
Standard Deviation 26.35
|
6.33 score on a scale
Standard Deviation 33.69
|
7.85 score on a scale
Standard Deviation 12.42
|
-0.55 score on a scale
Standard Deviation 17.91
|
SECONDARY outcome
Timeframe: Change from baseline to six-month follow-upThe SF-36 physical functioning score will be used to measure quality of life. They are scored on a 0-100 scale and that 100 indicates the best possible score.
Outcome measures
| Measure |
Telmisartan + Supervised Treadmill Exercise Therapy
n=29 Participants
Participants in this group will receive both daily telmisartan and supervised treadmill exercise three days weekly for six months.
Supervised Treadmill Exercise Therapy: Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.
Telmisartan: Participants randomized to the telmisartan arm of the study will take 20 mg or 40 mg of telmisartan daily based on the results of their study run-in. Participants will have their dose increased to up to 80 mg as tolerated.
|
Telmisartan + "No Exercise" Control Group
n=26 Participants
Participants in this group will receive daily telmisartan and attend weekly educational lectures at the medical center for six months.
Telmisartan: Participants randomized to the telmisartan arm of the study will take 20 mg or 40 mg of telmisartan daily based on the results of their study run-in. Participants will have their dose increased to up to 80 mg as tolerated.
"No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.
|
Placebo + Supervised Treadmill Exercise Therapy
n=24 Participants
Participants randomized to this group will receive daily placebo and supervised treadmill exercise three times weekly for six months.
Supervised Treadmill Exercise Therapy: Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.
Placebo
|
Placebo + "No Exercise" Control Group
n=24 Participants
Participants randomized to this group will receive daily placebo and health education lectures weekly for six months.
"No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.
Placebo
|
|---|---|---|---|---|
|
SF-36 Physical Functioning Score
|
0.69 score on a scale
Standard Deviation 21.16
|
5.96 score on a scale
Standard Deviation 20.69
|
8.75 score on a scale
Standard Deviation 21.68
|
0.21 score on a scale
Standard Deviation 20.56
|
SECONDARY outcome
Timeframe: Change from baseline to six-month follow-upThe WIQ is a well validated questionnaire that measures patient-reported walking limitations in distance and speed and stair-climbing. They are scored on a 0-100 scale and that 100 indicates the best possible score.
Outcome measures
| Measure |
Telmisartan + Supervised Treadmill Exercise Therapy
n=29 Participants
Participants in this group will receive both daily telmisartan and supervised treadmill exercise three days weekly for six months.
Supervised Treadmill Exercise Therapy: Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.
Telmisartan: Participants randomized to the telmisartan arm of the study will take 20 mg or 40 mg of telmisartan daily based on the results of their study run-in. Participants will have their dose increased to up to 80 mg as tolerated.
|
Telmisartan + "No Exercise" Control Group
n=26 Participants
Participants in this group will receive daily telmisartan and attend weekly educational lectures at the medical center for six months.
Telmisartan: Participants randomized to the telmisartan arm of the study will take 20 mg or 40 mg of telmisartan daily based on the results of their study run-in. Participants will have their dose increased to up to 80 mg as tolerated.
"No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.
|
Placebo + Supervised Treadmill Exercise Therapy
n=24 Participants
Participants randomized to this group will receive daily placebo and supervised treadmill exercise three times weekly for six months.
Supervised Treadmill Exercise Therapy: Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.
Placebo
|
Placebo + "No Exercise" Control Group
n=24 Participants
Participants randomized to this group will receive daily placebo and health education lectures weekly for six months.
"No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.
Placebo
|
|---|---|---|---|---|
|
Walking Impairment Questionnaire (WIQ) Speed Score
|
2.74 score on a scale
Standard Deviation 25.64
|
4.81 score on a scale
Standard Deviation 26.41
|
11.46 score on a scale
Standard Deviation 16.52
|
1.72 score on a scale
Standard Deviation 17.36
|
SECONDARY outcome
Timeframe: Change from baseline to six-month follow-upThe WIQ is a well validated questionnaire that measures patient-reported walking limitations in distance and speed and stair-climbing. They are scored on a 0-100 scale and that 100 indicates the best possible score.
Outcome measures
| Measure |
Telmisartan + Supervised Treadmill Exercise Therapy
n=29 Participants
Participants in this group will receive both daily telmisartan and supervised treadmill exercise three days weekly for six months.
Supervised Treadmill Exercise Therapy: Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.
Telmisartan: Participants randomized to the telmisartan arm of the study will take 20 mg or 40 mg of telmisartan daily based on the results of their study run-in. Participants will have their dose increased to up to 80 mg as tolerated.
|
Telmisartan + "No Exercise" Control Group
n=26 Participants
Participants in this group will receive daily telmisartan and attend weekly educational lectures at the medical center for six months.
Telmisartan: Participants randomized to the telmisartan arm of the study will take 20 mg or 40 mg of telmisartan daily based on the results of their study run-in. Participants will have their dose increased to up to 80 mg as tolerated.
"No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.
|
Placebo + Supervised Treadmill Exercise Therapy
n=24 Participants
Participants randomized to this group will receive daily placebo and supervised treadmill exercise three times weekly for six months.
Supervised Treadmill Exercise Therapy: Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.
Placebo
|
Placebo + "No Exercise" Control Group
n=24 Participants
Participants randomized to this group will receive daily placebo and health education lectures weekly for six months.
"No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.
Placebo
|
|---|---|---|---|---|
|
Walking Impairment Questionnaire (WIQ) Stair-climbing Score
|
2.73 score on a scale
Standard Deviation 34.81
|
3.37 score on a scale
Standard Deviation 28.58
|
10.59 score on a scale
Standard Deviation 24.14
|
-2.08 score on a scale
Standard Deviation 21.21
|
Adverse Events
Telmisartan + Supervised Treadmill Exercise Therapy
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
Telmisartan + "No Exercise" Control Group
Serious events: 5 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo + Supervised Treadmill Exercise Therapy
Serious events: 6 serious events
Other events: 23 other events
Deaths: 1 deaths
Placebo + "No Exercise" Control Group
Serious events: 7 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Telmisartan + Supervised Treadmill Exercise Therapy
n=30 participants at risk
Participants in this group will receive both daily telmisartan and supervised treadmill exercise three days weekly for six months.
Supervised Treadmill Exercise Therapy: Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.
Telmisartan: Participants randomized to the telmisartan arm of the study will take 20 mg or 40 mg of telmisartan daily based on the results of their study run-in. Participants will have their dose increased to up to 80 mg as tolerated.
|
Telmisartan + "No Exercise" Control Group
n=29 participants at risk
Participants in this group will receive daily telmisartan and attend weekly educational lectures at the medical center for six months.
Telmisartan: Participants randomized to the telmisartan arm of the study will take 20 mg or 40 mg of telmisartan daily based on the results of their study run-in. Participants will have their dose increased to up to 80 mg as tolerated.
"No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.
|
Placebo + Supervised Treadmill Exercise Therapy
n=28 participants at risk
Participants randomized to this group will receive daily placebo and supervised treadmill exercise three times weekly for six months.
Supervised Treadmill Exercise Therapy: Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.
Placebo
|
Placebo + "No Exercise" Control Group
n=27 participants at risk
Participants randomized to this group will receive daily placebo and health education lectures weekly for six months.
"No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.
Placebo
|
|---|---|---|---|---|
|
General disorders
Depression
|
0.00%
0/30 • Adverse events data were collected during the 6-month intervention period.
|
10.3%
3/29 • Number of events 3 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/28 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/27 • Adverse events data were collected during the 6-month intervention period.
|
|
Vascular disorders
Coronary revascularization
|
0.00%
0/30 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/29 • Adverse events data were collected during the 6-month intervention period.
|
7.1%
2/28 • Number of events 2 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/27 • Adverse events data were collected during the 6-month intervention period.
|
|
Vascular disorders
Lower extremity revascularization
|
3.3%
1/30 • Number of events 1 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/29 • Adverse events data were collected during the 6-month intervention period.
|
3.6%
1/28 • Number of events 1 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/27 • Adverse events data were collected during the 6-month intervention period.
|
|
General disorders
Stroke
|
0.00%
0/30 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/29 • Adverse events data were collected during the 6-month intervention period.
|
7.1%
2/28 • Number of events 2 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/27 • Adverse events data were collected during the 6-month intervention period.
|
|
Infections and infestations
Toe gangrene/infection
|
6.7%
2/30 • Number of events 2 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/29 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/28 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/27 • Adverse events data were collected during the 6-month intervention period.
|
|
General disorders
Anemia
|
0.00%
0/30 • Adverse events data were collected during the 6-month intervention period.
|
3.4%
1/29 • Number of events 1 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/28 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/27 • Adverse events data were collected during the 6-month intervention period.
|
|
General disorders
Aortic aneurysm
|
0.00%
0/30 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/29 • Adverse events data were collected during the 6-month intervention period.
|
3.6%
1/28 • Number of events 1 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/27 • Adverse events data were collected during the 6-month intervention period.
|
|
General disorders
Arrhythmia
|
3.3%
1/30 • Number of events 1 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/29 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/28 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/27 • Adverse events data were collected during the 6-month intervention period.
|
|
Cardiac disorders
Carotid artery revascularization
|
0.00%
0/30 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/29 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/28 • Adverse events data were collected during the 6-month intervention period.
|
3.7%
1/27 • Number of events 1 • Adverse events data were collected during the 6-month intervention period.
|
|
General disorders
Chest pain
|
3.3%
1/30 • Number of events 1 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/29 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/28 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/27 • Adverse events data were collected during the 6-month intervention period.
|
|
General disorders
Chest pain- non-cardiac
|
0.00%
0/30 • Adverse events data were collected during the 6-month intervention period.
|
3.4%
1/29 • Number of events 1 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/28 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/27 • Adverse events data were collected during the 6-month intervention period.
|
|
General disorders
Diarrhea
|
0.00%
0/30 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/29 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/28 • Adverse events data were collected during the 6-month intervention period.
|
3.7%
1/27 • Number of events 1 • Adverse events data were collected during the 6-month intervention period.
|
|
Surgical and medical procedures
Elective orthopedic surgery
|
0.00%
0/30 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/29 • Adverse events data were collected during the 6-month intervention period.
|
3.6%
1/28 • Number of events 1 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/27 • Adverse events data were collected during the 6-month intervention period.
|
|
Surgical and medical procedures
Elective pacemaker placement
|
3.3%
1/30 • Number of events 1 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/29 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/28 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/27 • Adverse events data were collected during the 6-month intervention period.
|
|
General disorders
Fatigue
|
0.00%
0/30 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/29 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/28 • Adverse events data were collected during the 6-month intervention period.
|
3.7%
1/27 • Number of events 1 • Adverse events data were collected during the 6-month intervention period.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/30 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/29 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/28 • Adverse events data were collected during the 6-month intervention period.
|
3.7%
1/27 • Number of events 1 • Adverse events data were collected during the 6-month intervention period.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/30 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/29 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/28 • Adverse events data were collected during the 6-month intervention period.
|
3.7%
1/27 • Number of events 1 • Adverse events data were collected during the 6-month intervention period.
|
|
General disorders
Hematoma
|
3.3%
1/30 • Number of events 1 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/29 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/28 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/27 • Adverse events data were collected during the 6-month intervention period.
|
|
General disorders
Hypertensive urgency
|
0.00%
0/30 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/29 • Adverse events data were collected during the 6-month intervention period.
|
3.6%
1/28 • Number of events 1 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/27 • Adverse events data were collected during the 6-month intervention period.
|
|
Infections and infestations
Infection
|
0.00%
0/30 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/29 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/28 • Adverse events data were collected during the 6-month intervention period.
|
3.7%
1/27 • Number of events 1 • Adverse events data were collected during the 6-month intervention period.
|
|
Surgical and medical procedures
Lower extremity revascularization/Amputation
|
0.00%
0/30 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/29 • Adverse events data were collected during the 6-month intervention period.
|
3.6%
1/28 • Number of events 1 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/27 • Adverse events data were collected during the 6-month intervention period.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/30 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/29 • Adverse events data were collected during the 6-month intervention period.
|
3.6%
1/28 • Number of events 1 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/27 • Adverse events data were collected during the 6-month intervention period.
|
|
General disorders
Opioid addiction
|
0.00%
0/30 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/29 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/28 • Adverse events data were collected during the 6-month intervention period.
|
3.7%
1/27 • Number of events 1 • Adverse events data were collected during the 6-month intervention period.
|
|
General disorders
Panic attack
|
0.00%
0/30 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/29 • Adverse events data were collected during the 6-month intervention period.
|
3.6%
1/28 • Number of events 1 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/27 • Adverse events data were collected during the 6-month intervention period.
|
|
General disorders
Tachycardia
|
0.00%
0/30 • Adverse events data were collected during the 6-month intervention period.
|
3.4%
1/29 • Number of events 1 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/28 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/27 • Adverse events data were collected during the 6-month intervention period.
|
|
Infections and infestations
Toe infection
|
3.3%
1/30 • Number of events 1 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/29 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/28 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/27 • Adverse events data were collected during the 6-month intervention period.
|
|
Infections and infestations
Urinary tract infection
|
3.3%
1/30 • Number of events 1 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/29 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/28 • Adverse events data were collected during the 6-month intervention period.
|
0.00%
0/27 • Adverse events data were collected during the 6-month intervention period.
|
Other adverse events
| Measure |
Telmisartan + Supervised Treadmill Exercise Therapy
n=30 participants at risk
Participants in this group will receive both daily telmisartan and supervised treadmill exercise three days weekly for six months.
Supervised Treadmill Exercise Therapy: Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.
Telmisartan: Participants randomized to the telmisartan arm of the study will take 20 mg or 40 mg of telmisartan daily based on the results of their study run-in. Participants will have their dose increased to up to 80 mg as tolerated.
|
Telmisartan + "No Exercise" Control Group
n=29 participants at risk
Participants in this group will receive daily telmisartan and attend weekly educational lectures at the medical center for six months.
Telmisartan: Participants randomized to the telmisartan arm of the study will take 20 mg or 40 mg of telmisartan daily based on the results of their study run-in. Participants will have their dose increased to up to 80 mg as tolerated.
"No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.
|
Placebo + Supervised Treadmill Exercise Therapy
n=28 participants at risk
Participants randomized to this group will receive daily placebo and supervised treadmill exercise three times weekly for six months.
Supervised Treadmill Exercise Therapy: Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.
Placebo
|
Placebo + "No Exercise" Control Group
n=27 participants at risk
Participants randomized to this group will receive daily placebo and health education lectures weekly for six months.
"No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.
Placebo
|
|---|---|---|---|---|
|
General disorders
Increase in shortness of breath
|
23.3%
7/30 • Number of events 11 • Adverse events data were collected during the 6-month intervention period.
|
31.0%
9/29 • Number of events 16 • Adverse events data were collected during the 6-month intervention period.
|
25.0%
7/28 • Number of events 13 • Adverse events data were collected during the 6-month intervention period.
|
37.0%
10/27 • Number of events 14 • Adverse events data were collected during the 6-month intervention period.
|
|
General disorders
New chest pain during exertion
|
6.7%
2/30 • Number of events 5 • Adverse events data were collected during the 6-month intervention period.
|
13.8%
4/29 • Number of events 4 • Adverse events data were collected during the 6-month intervention period.
|
10.7%
3/28 • Number of events 3 • Adverse events data were collected during the 6-month intervention period.
|
7.4%
2/27 • Number of events 2 • Adverse events data were collected during the 6-month intervention period.
|
|
General disorders
Sinus discomfort or congestion
|
66.7%
20/30 • Number of events 54 • Adverse events data were collected during the 6-month intervention period.
|
48.3%
14/29 • Number of events 46 • Adverse events data were collected during the 6-month intervention period.
|
57.1%
16/28 • Number of events 50 • Adverse events data were collected during the 6-month intervention period.
|
66.7%
18/27 • Number of events 60 • Adverse events data were collected during the 6-month intervention period.
|
|
General disorders
Back pain
|
60.0%
18/30 • Number of events 74 • Adverse events data were collected during the 6-month intervention period.
|
51.7%
15/29 • Number of events 54 • Adverse events data were collected during the 6-month intervention period.
|
82.1%
23/28 • Number of events 85 • Adverse events data were collected during the 6-month intervention period.
|
55.6%
15/27 • Number of events 60 • Adverse events data were collected during the 6-month intervention period.
|
|
General disorders
Diarrhea
|
56.7%
17/30 • Number of events 37 • Adverse events data were collected during the 6-month intervention period.
|
48.3%
14/29 • Number of events 38 • Adverse events data were collected during the 6-month intervention period.
|
60.7%
17/28 • Number of events 61 • Adverse events data were collected during the 6-month intervention period.
|
40.7%
11/27 • Number of events 33 • Adverse events data were collected during the 6-month intervention period.
|
|
General disorders
Dizziness or lightheadedness
|
30.0%
9/30 • Number of events 14 • Adverse events data were collected during the 6-month intervention period.
|
31.0%
9/29 • Number of events 15 • Adverse events data were collected during the 6-month intervention period.
|
32.1%
9/28 • Number of events 12 • Adverse events data were collected during the 6-month intervention period.
|
29.6%
8/27 • Number of events 14 • Adverse events data were collected during the 6-month intervention period.
|
|
General disorders
Swelling in the face, lips or tongue
|
16.7%
5/30 • Number of events 10 • Adverse events data were collected during the 6-month intervention period.
|
3.4%
1/29 • Number of events 2 • Adverse events data were collected during the 6-month intervention period.
|
7.1%
2/28 • Number of events 2 • Adverse events data were collected during the 6-month intervention period.
|
3.7%
1/27 • Number of events 6 • Adverse events data were collected during the 6-month intervention period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place