Telmisartan Plus Exercise to Improve Functioning in Peripheral Artery Disease
TELEX
2 other identifiers
interventional
114
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2016
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2015
CompletedFirst Posted
Study publicly available on registry
October 30, 2015
CompletedStudy Start
First participant enrolled
January 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 6, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2022
CompletedResults Posted
Study results publicly available
January 11, 2023
CompletedJanuary 11, 2023
December 1, 2022
6.3 years
October 27, 2015
November 14, 2022
December 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Maximal Treadmill Walking Distance
Change from baseline to six-month follow-up
Walking Impairment Questionnaire (WIQ) Distance Score
Change from baseline to six-month follow-up
SF-36 Physical Functioning Score
Change from baseline to six-month follow-up
Walking Impairment Questionnaire (WIQ) Speed Score
Change from baseline to six-month follow-up
Walking Impairment Questionnaire (WIQ) Stair-climbing Score
Change from baseline to six-month follow-up
Study Arms (4)
Telmisartan + Supervised Treadmill Exercise Therapy
ACTIVE COMPARATORParticipants in this group will receive both daily telmisartan and supervised treadmill exercise three days weekly for six months.
Telmisartan + "No Exercise" Control Group
ACTIVE COMPARATORParticipants 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 COMPARATORParticipants randomized to this group will receive daily placebo and supervised treadmill exercise three times weekly for six months.
Placebo + "No Exercise" Control Group
PLACEBO COMPARATORParticipants randomized to this group will receive daily placebo and health education lectures weekly for six months.
Interventions
Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.
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.
Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.
Eligibility Criteria
You may not qualify if:
- 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.
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Northwestern University
Chicago, Illinois, 60611, United States
Tulane University
New Orleans, Louisiana, 70112, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
Related Publications (1)
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.
PMID: 36194220DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mary McDermott MD
- Organization
- Northwestern University
Study Officials
- PRINCIPAL INVESTIGATOR
Mary McDermott, MD
Northwestern University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Jeremiah Stamler Professor
Study Record Dates
First Submitted
October 27, 2015
First Posted
October 30, 2015
Study Start
January 4, 2016
Primary Completion
May 6, 2022
Study Completion
June 15, 2022
Last Updated
January 11, 2023
Results First Posted
January 11, 2023
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share