Telmisartan Plus Exercise to Improve Functioning in Peripheral Artery Disease

NCT ID: NCT02593110

Last Updated: 2023-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-04
• Study Completion Date: 2022-06-15

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.

Conditions

Peripheral Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Telmisartan + Supervised Treadmill Exercise Therapy

Participants in this group will receive both daily telmisartan and supervised treadmill exercise three days weekly for six months.

Group Type: ACTIVE_COMPARATOR

Supervised Treadmill Exercise Therapy

Intervention Type: BEHAVIORAL

Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.

Telmisartan

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

Telmisartan

Intervention Type: DRUG

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

Intervention Type: OTHER

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.

Group Type: ACTIVE_COMPARATOR

Supervised Treadmill Exercise Therapy

Intervention Type: BEHAVIORAL

Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.

Placebo

Intervention Type: DRUG

Placebo + "No Exercise" Control Group

Participants randomized to this group will receive daily placebo and health education lectures weekly for six months.

Group Type: PLACEBO_COMPARATOR

"No exercise" control group

Intervention Type: OTHER

Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.

Placebo

Intervention Type: DRUG

Interventions

Supervised Treadmill Exercise Therapy

Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DRUG

"No exercise" control group

Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.

Intervention Type: OTHER

Placebo

Intervention Type: DRUG

Other Intervention Names

Treadmill exercise; Micardis; Attention control group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Mary McDermott

Jeremiah Stamler Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary McDermott, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Tulane University

New Orleans, Louisiana, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Countries

United States

References

McDermott MM, Bazzano L, Peterson CA, Sufit R, Ferrucci L, Domanchuk K, Zhao L, Polonsky TS, Zhang D, Lloyd-Jones D, Leeuwenburgh C, Guralnik JM, Kibbe MR, Kosmac K, Criqui MH, Tian L. Effect of Telmisartan on Walking Performance in Patients With Lower Extremity Peripheral Artery Disease: The TELEX Randomized Clinical Trial. JAMA. 2022 Oct 4;328(13):1315-1325. doi: 10.1001/jama.2022.16797.

Reference Type: DERIVED

PMID: 36194220 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01HL126117

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU00200954

Identifier Type: -

Identifier Source: org_study_id