Telmisartan Plus Exercise to Improve Functioning in Peripheral Artery Disease

Not Applicable

Completed

• Conditions: Peripheral Artery Disease
• Interventions: Behavioral: Supervised Treadmill Exercise Therapy; Drug: Telmisartan; Other: "No exercise" control group; Drug: Placebo

• Registration Number: NCT02593110
• Lead Sponsor: Northwestern University

Brief Summary

The TELEX trial will establish whether telmisartan alone improves walking performance in people with peripheral artery disease (PAD). The TELEX trial will also determine whether telmisartan plus supervised exercise improves walking performance more than either therapy alone. TELEX is a randomized controlled clinical trial (2 x 2 factorial design) of 112 participants with PAD randomized to one of four arms: Group A: telmisartan + supervised exercise therapy; Group B: telmisartan + a "no exercise" control group; Group C: placebo + supervised exercise therapy; and Group D: placebo + a "no exercise" control group.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-27
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-10-30
• Study Start: 2016-01-04
• Primary Completion: 2022-05-06
• Study Completion: 2022-06-15
• Results First Submitted: 2022-11-14
• Status Verified: 2022-12
• Results First Submitted QC: 2022-12-15
• Last Update Submitted: 2022-12-15
• Results First Posted: 2023-01-11
• Last Update Posted: 2023-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

All participants will have PAD. PAD will be defined as follows. First, an ABI <= 0.90 at the baseline study visit is an inclusion criterion for PAD. Second, potential participants who have an ABI > 0.90 but ≤ 1.00 and experience a 20% or higher drop in ABI after heel-rise exercise will be eligible. Third, potential participants with an ABI > 0.90 who have vascular lab evidence of PAD or angiographic evidence of PAD will be eligible. Finally, potential participants with a history of lower extremity revascularization who do not meet the criterion above and have an ABI > 0.90 with a 20% or higher drop in ABI after heel-rise exercise will be eligible.

Exclusion Criteria

1. Above or below knee amputation, critical limb ischemia, wheelchair confinement, inability to walk without a walker, or current foot ulcer.
2. Walking is limited by a condition other than PAD.
3. > Class II NYHA heart failure or angina, increase in angina, angina at rest, or abnormal baseline treadmill stress test. Potential participants may become eligible following an abnormal baseline treadmill stress test if they have evidence of an absence of coronary ischemia based on testing with their own physician.
4. Currently taking an angiotensin receptor blocker or an ACE inhibitor or use of these medications in the past three months.
5. Currently taking aliskiren (Tekturna).
6. Blood pressure < 100/50 at baseline or potassium > 5.0 meq/L at baseline.
7. Blood pressure < 100/50 after run-in or potassium >= 5.5 meq/L at the end of run-in.
8. Severe hepatic impairment defined by two or more liver function enzyme values greater than 2.5 the upper limit of normal.
9. Acute decline in renal function on telmisartan, defined as a 30% or greater decline in eGFR following the two-week run-in as compared to baseline. If the participant had a baseline eGFR performed by his/her physician within two months of the baseline eGFR for the TELEX trial, the participant's physician's eGFR may be considered the baseline measure, at the study principal investigator's discretion.
10. Allergy to ARBs.
11. Failure to successfully complete the 2-week study run-in, defined as failing to attend the health education and treadmill exercise run-in sessions and/or failing to take the study medication daily for 10 or more days in the two-week period (i.e. one pill per day for > 10 days out of the 14 day run-in period).
12. Surgery including lower extremity revascularization, coronary revascularization with stenting, or orthopedic surgery during the past 3 months or anticipated in the next 6 months or myocardial infarction or stroke in the past 3 months.
13. Major medical illness including renal disease requiring dialysis, lung disease requiring oxygen, Parkinson's disease, a life-threatening illness with life expectancy less than six months, or cancer requiring treatment in the previous two years. [NOTE: potential participants may still qualify if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent. Participants who only use oxygen at night may still qualify.]
14. MMSE score < 23 or dementia.
15. Currently walking regularly for exercise at a level similar to the study intervention.
16. Participation in another clinical trial or cardiac rehabilitation or completion of a clinical trial or cardiac rehabilitation in the previous three months. [NOTE: after completing a stem cell or gene therapy intervention, participants will become eligible after the final study follow-up visit of the stem cell or gene therapy study so long as at least six months have passed since the final intervention administration. After completing an exercise intervention or a supplement or drug therapy (other than stem cell or gene therapy), participants will be eligible after the final study follow-up visit as long as at least three months have passed since the final intervention of the trial.]
17. Non-English speaking, a visual impairment that limits walking ability, or a hearing impairment that interferes with study participation.
18. Congestive heart failure with an ejection fraction <40.
19. In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Telmisartan + Supervised Treadmill Exercise Therapy	Supervised Treadmill Exercise Therapy	Participants in this group will receive both daily telmisartan and supervised treadmill exercise three days weekly for six months.
Telmisartan + "No Exercise" Control Group	"No exercise" control group	Participants in this group will receive daily telmisartan and attend weekly educational lectures at the medical center for six months.
Placebo + Supervised Treadmill Exercise Therapy	Supervised Treadmill Exercise Therapy	Participants randomized to this group will receive daily placebo and supervised treadmill exercise three times weekly for six months.
Placebo + Supervised Treadmill Exercise Therapy	Placebo	Participants randomized to this group will receive daily placebo and supervised treadmill exercise three times weekly for six months.
Placebo + "No Exercise" Control Group	"No exercise" control group	Participants randomized to this group will receive daily placebo and health education lectures weekly for six months.
Placebo + "No Exercise" Control Group	Placebo	Participants randomized to this group will receive daily placebo and health education lectures weekly for six months.
Telmisartan + "No Exercise" Control Group	Telmisartan	Participants in this group will receive daily telmisartan and attend weekly educational lectures at the medical center for six months.
Telmisartan + Supervised Treadmill Exercise Therapy	Telmisartan	Participants in this group will receive both daily telmisartan and supervised treadmill exercise three days weekly for six months.

Primary Outcome Measures

Name	Time	Method
Six-minute Walk Performance	Change from baseline to six-month follow-up	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).

Secondary Outcome Measures

Name	Time	Method
Walking Impairment Questionnaire (WIQ) Distance Score	Change from baseline to six-month follow-up	The 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.
SF-36 Physical Functioning Score	Change from baseline to six-month follow-up	The 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.
Walking Impairment Questionnaire (WIQ) Speed Score	Change from baseline to six-month follow-up	The 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.
Walking Impairment Questionnaire (WIQ) Stair-climbing Score	Change from baseline to six-month follow-up	The 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.
Maximal Treadmill Walking Distance	Change from baseline to six-month follow-up	In the treadmill walking test, participants walk on either a gardner or modified gardner protocol until they stop the test. Distance walked is recorded.

Trial Locations

Locations (3)

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Tulane University; 🇺🇸 New Orleans, Louisiana, United States

Ochsner Medical Center; 🇺🇸 New Orleans, Louisiana, United States