Telmisartan Plus Exercise to Improve Functioning in Peripheral Artery Disease

Peripheral Artery Disease Clinical Trial

— TELEX  

Official title:

Telmisartan Plus Exercise to Improve Functioning in Peripheral Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02593110
• Other study ID #: STU00200954
• Secondary ID: R01HL126117
• Status: Completed
• Phase: N/A
• Start date: January 4, 2016
• Est. completion date: June 15, 2022

Study information

• Verified date: December 2022
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: June 15, 2022
• Est. primary completion date: May 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Behavioral:
• Supervised Treadmill Exercise Therapy
Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.

Drug:
• 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.

Other:
• "No exercise" control group
Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.

Drug:
• Placebo

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Tulane University	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six-minute Walk Performance	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).	Change from baseline to six-month follow-up
Secondary	Maximal Treadmill Walking Distance	In the treadmill walking test, participants walk on either a gardner or modified gardner protocol until they stop the test. Distance walked is recorded.	Change from baseline to six-month follow-up
Secondary	Walking Impairment Questionnaire (WIQ) Distance Score	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.	Change from baseline to six-month follow-up
Secondary	SF-36 Physical Functioning Score	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.	Change from baseline to six-month follow-up
Secondary	Walking Impairment Questionnaire (WIQ) Speed Score	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.	Change from baseline to six-month follow-up
Secondary	Walking Impairment Questionnaire (WIQ) Stair-climbing Score	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.	Change from baseline to six-month follow-up