Peripheral Artery DiseaseTELEXNCT02593110
Telmisartan Plus Exercise to Improve Functioning in Peripheral Artery Disease
A study testing Supervised Treadmill Exercise Therapy and Telmisartan in people with Peripheral Artery Disease, run by Northwestern University at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Supervised Treadmill Exercise Therapy and Telmisartan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Jan 2016to 15 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Above or below knee amputation, critical limb ischemia, wheelchair confinement, inability to walk without a walker, or current foot ulcer.
- Walking is limited by a condition other than PAD.
- > 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.
- Currently taking an angiotensin receptor blocker or an ACE inhibitor or use of these medications in the past three months.
- Currently taking aliskiren (Tekturna).
- Blood pressure < 100/50 at baseline or potassium > 5.0 meq/L at baseline.
Show all 19Show fewer
- Blood pressure < 100/50 after run-in or potassium >= 5.5 meq/L at the end of run-in.
- Severe hepatic impairment defined by two or more liver function enzyme values greater than 2.5 the upper limit of normal.
- 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.
- Allergy to ARBs.
- 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).
- 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.
- 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.]
- MMSE score < 23 or dementia.
- Currently walking regularly for exercise at a level similar to the study intervention.
- 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.]
- Non-English speaking, a visual impairment that limits walking ability, or a hearing impairment that interferes with study participation.
- Congestive heart failure with an ejection fraction <40.
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Northwestern University
Chicago, Illinois, 60611
Tulane University
New Orleans, Louisiana, 70112
Ochsner Medical Center
New Orleans, Louisiana, 70121
About this study
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
- Being tested
- Supervised Treadmill Exercise Therapy, Telmisartan, "No exercise" control group, Placebo
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Treadmill Exercise TherapyBehavioural
Also called Treadmill exercise
Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.
TelmisartanDrug
Also called Micardis
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 groupOther
Also called Attention control group
Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan + Supervised Treadmill Exercise Therapy | Active comparator | Participants in this group will receive both daily telmisartan and supervised treadmill exercise three days weekly for six months. Receives: Behavioral: Supervised Treadmill Exercise Therapy; Drug: Telmisartan |
| Telmisartan + "No Exercise" Control Group | Active comparator | Participants in this group will receive daily telmisartan and attend weekly educational lectures at the medical center for six months. Receives: Drug: Telmisartan; Other: "No exercise" control group |
| Placebo + Supervised Treadmill Exercise Therapy | Active comparator | Participants randomized to this group will receive daily placebo and supervised treadmill exercise three times weekly for six months. Receives: Behavioral: Supervised Treadmill Exercise Therapy; Drug: Placebo |
| Placebo + "No Exercise" Control Group | Placebo comparator | Participants randomized to this group will receive daily placebo and health education lectures weekly for six months. Receives: Other: "No exercise" control group; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from baseline to six-month follow-up
Secondary outcomes (5)
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.
Measured: Change from baseline to six-month follow-up
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.
Measured: Change from baseline to six-month follow-up
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.
Measured: Change from baseline to six-month follow-up
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.
Measured: Change from baseline to six-month follow-up
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.
Measured: Change from baseline to six-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study start4 Jan 2016
- Primary completion6 May 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Mary McDermott, Northwestern University
- Investigators
- Mary McDermott, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593110
- Sponsor's protocol ID
- STU00200954
- Other IDs
- R01HL126117
- Acronym
- TELEX
- Status last verified
- Dec 2022
- First submitted
- 27 Oct 2015
- Last updated
- 11 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
McDermott MM, Cetlin MD, Domanchuk KJ, Xu S, Whipple MO, Polonsky T, Criqui MH, Guralnik JM, Tian L, Zhao L, Ho KJ, Greenland P, Treat-Jacobson D. Community-based recruitment with ankle brachial index testing to identify peripheral artery disease participants for randomized clinical trials. Am Heart J. 2026 Oct;300:107450. doi: 10.1016/j.ahj.2026.107450. Epub 2026 Apr 24.
PubMed 42035974McDermott 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.
PubMed 36194220
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telmisartan Plus Exercise to Improve Functioning in Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT02593110
- Acronym / sponsor ID
- TELEX / STU00200954
- Conditions
- Peripheral Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 4 Jan 2016 (actual)
- Primary completion
- 6 May 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 30 Oct 2015 (estimated)
- Results
- Posted 11 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Telmisartan + Supervised Treadmill Exercise Therapy | Active comparator | Behavioral: Supervised Treadmill Exercise Therapy, Drug: TelmisartanParticipants in this group will receive both daily telmisartan and supervised treadmill exercise three days weekly for six months. |
| Telmisartan + "No Exercise" Control Group | Active comparator | Drug: Telmisartan, Other: "No exercise" control groupParticipants in this group will receive daily telmisartan and attend weekly educational lectures at the medical center for six months. |
| Placebo + Supervised Treadmill Exercise Therapy | Active comparator | Behavioral: Supervised Treadmill Exercise Therapy, Drug: PlaceboParticipants randomized to this group will receive daily placebo and supervised treadmill exercise three times weekly for six months. |
| Placebo + "No Exercise" Control Group | Placebo comparator | Other: "No exercise" control group, Drug: PlaceboParticipants randomized to this group will receive daily placebo and health education lectures weekly for six months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (19 listed)
- Above or below knee amputation, critical limb ischemia, wheelchair confinement, inability to walk without a walker, or current foot ulcer.
- Walking is limited by a condition other than PAD.
- > 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.
- Currently taking an angiotensin receptor blocker or an ACE inhibitor or use of these medications in the past three months.
- Currently taking aliskiren (Tekturna).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised Treadmill Exercise TherapyAlso: Treadmill exerciseParticipants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months. | Behavioural | Placebo + Supervised Treadmill Exercise Therapy, Telmisartan + Supervised Treadmill Exercise Therapy |
| TelmisartanAlso: MicardisParticipants 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. | Drug | Telmisartan + "No Exercise" Control Group, Telmisartan + Supervised Treadmill Exercise Therapy |
| "No exercise" control groupAlso: Attention control groupParticipants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months. | Other | Placebo + "No Exercise" Control Group, Telmisartan + "No Exercise" Control Group |
| Placebo | Drug | Placebo + "No Exercise" Control Group, Placebo + Supervised Treadmill Exercise Therapy |
Primary outcome
Six-minute Walk Performance
Time frame: 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).
5 secondary outcomes
Maximal Treadmill Walking Distance
Time frame: Change from baseline to six-month follow-up
Walking Impairment Questionnaire (WIQ) Distance Score
Time frame: Change from baseline to six-month follow-up
SF-36 Physical Functioning Score
Time frame: Change from baseline to six-month follow-up
Walking Impairment Questionnaire (WIQ) Speed Score
Time frame: Change from baseline to six-month follow-up
Walking Impairment Questionnaire (WIQ) Stair-climbing Score
Time frame: Change from baseline to six-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42035974McDermott MM, Cetlin MD, Domanchuk KJ, Xu S, Whipple MO, Polonsky T, Criqui MH, Guralnik JM, Tian L, Zhao L, Ho KJ, Greenland P, Treat-Jacobson D. Community-based recruitment with ankle brachial index testing to identify peripheral artery disease participants for randomized clinical trials. Am Heart J. 2026 Oct;300:107450. doi: 10.1016/j.ahj.2026.107450. Epub 2026 Apr 24.
- Derived from this study: PubMed 36194220McDermott 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary McDermott, MD principal investigator
Northwestern University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Treadmill Exercise Therapy and Telmisartan in people with Peripheral Artery Disease, run by Northwestern University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-minute Walk Performance (time frame: Change from baseline to six-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02593110, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.