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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL126117 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Placebo + "No Exercise" Control Group | Placebo Comparator | Participants randomized to this group will receive daily placebo and health education lectures weekly for six months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supervised Treadmill Exercise Therapy | Behavioral | Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Walking Impairment Questionnaire (WIQ) Distance Score |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Mary McDermott, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| Tulane University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42035974 | Derived | 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 Apr 24;300:107450. doi: 10.1016/j.ahj.2026.107450. Online ahead of print. | |
| 36194220 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Telmisartan + Supervised Treadmill Exercise Therapy | Participants in this group will receive both daily telmisartan and supervised treadmill exercise three days weekly for six months. Supervised Treadmill Exercise Therapy: Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months. 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. |
| FG001 | 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. 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. "No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months. |
| FG002 | Placebo + Supervised Treadmill Exercise Therapy | Participants randomized to this group will receive daily placebo and supervised treadmill exercise three times weekly for six months. Supervised Treadmill Exercise Therapy: Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months. Placebo |
| FG003 | Placebo + "No Exercise" Control Group | Participants randomized to this group will receive daily placebo and health education lectures weekly for six months. "No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months. Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Telmisartan + Supervised Treadmill Exercise Therapy | Participants in this group will receive both daily telmisartan and supervised treadmill exercise three days weekly for six months. Supervised Treadmill Exercise Therapy: Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | meters | Change from baseline to six-month follow-up |
|
Adverse events data were collected during the 6-month intervention period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Telmisartan + Supervised Treadmill Exercise Therapy | Participants in this group will receive both daily telmisartan and supervised treadmill exercise three days weekly for six months. Supervised Treadmill Exercise Therapy: Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increase in shortness of breath | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary McDermott MD | Northwestern University | 312-503-6419 | mdm608@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 7, 2022 | Nov 14, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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Not provided
| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Telmisartan | 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 | Other | Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months. |
|
|
| Placebo | Drug |
|
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 |
| 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 |
| 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 |
| 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 |
| New Orleans |
| Louisiana |
| 70112 |
| United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Death |
|
| BG001 | 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. 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. "No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months. |
| BG002 | Placebo + Supervised Treadmill Exercise Therapy | Participants randomized to this group will receive daily placebo and supervised treadmill exercise three times weekly for six months. Supervised Treadmill Exercise Therapy: Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months. Placebo |
| BG003 | Placebo + "No Exercise" Control Group | Participants randomized to this group will receive daily placebo and health education lectures weekly for six months. "No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months. Placebo |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ankle-brachial index | ABI is a ratio of Doppler recorded arm and ankle pressures and that a value < 0.90 indicates PAD | Mean | Standard Deviation | ratio |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Six-min walk distance | Mean | Standard Deviation | meters |
|
| OG001 | 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. 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. "No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months. |
| OG002 | Placebo + Supervised Treadmill Exercise Therapy | Participants randomized to this group will receive daily placebo and supervised treadmill exercise three times weekly for six months. Supervised Treadmill Exercise Therapy: Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months. Placebo |
| OG003 | Placebo + "No Exercise" Control Group | Participants randomized to this group will receive daily placebo and health education lectures weekly for six months. "No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months. Placebo |
|
|
|
| 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. | Posted | Mean | Standard Deviation | meters | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to six-month follow-up |
|
|
|
|
| 0 |
| 30 |
| 4 |
| 30 |
| 20 |
| 30 |
| EG001 | 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. 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. "No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months. | 0 | 29 | 5 | 29 | 15 | 29 |
| EG002 | Placebo + Supervised Treadmill Exercise Therapy | Participants randomized to this group will receive daily placebo and supervised treadmill exercise three times weekly for six months. Supervised Treadmill Exercise Therapy: Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months. Placebo | 1 | 28 | 6 | 28 | 23 | 28 |
| EG003 | Placebo + "No Exercise" Control Group | Participants randomized to this group will receive daily placebo and health education lectures weekly for six months. "No exercise" control group: Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months. Placebo | 0 | 27 | 7 | 27 | 18 | 27 |
| Coronary revascularization | Vascular disorders | Systematic Assessment |
|
| Lower extremity revascularization | Vascular disorders | Systematic Assessment |
|
| Stroke | General disorders | Systematic Assessment |
|
| Toe gangrene/infection | Infections and infestations | Systematic Assessment |
|
| Anemia | General disorders | Systematic Assessment |
|
| Aortic aneurysm | General disorders | Systematic Assessment |
|
| Arrhythmia | General disorders | Systematic Assessment |
|
| Carotid artery revascularization | Cardiac disorders | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| Chest pain- non-cardiac | General disorders | Systematic Assessment |
|
| Diarrhea | General disorders | Systematic Assessment |
|
| Elective orthopedic surgery | Surgical and medical procedures | Systematic Assessment |
|
| Elective pacemaker placement | Surgical and medical procedures | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | Systematic Assessment |
|
| Heart failure | Cardiac disorders | Systematic Assessment |
|
| Hematoma | General disorders | Systematic Assessment |
|
| Hypertensive urgency | General disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Lower extremity revascularization/Amputation | Surgical and medical procedures | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | Systematic Assessment |
|
| Opioid addiction | General disorders | Systematic Assessment |
|
| Panic attack | General disorders | Systematic Assessment |
|
| Tachycardia | General disorders | Systematic Assessment |
|
| Toe infection | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| New chest pain during exertion | General disorders | Systematic Assessment |
|
| Sinus discomfort or congestion | General disorders | Systematic Assessment |
|
| Back pain | General disorders | Systematic Assessment |
|
| Diarrhea | General disorders | Systematic Assessment |
|
| Dizziness or lightheadedness | General disorders | Systematic Assessment |
|
| Swelling in the face, lips or tongue | General disorders | Systematic Assessment |
|
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Mean Difference (Final Values) |
| 141.78 |
| 2-Sided |
| 95 |
| 33.14 |
| 250.42 |
| Superiority |
| ANCOVA | 0.8146 | Mean Difference (Final Values) | -14.75 | 2-Sided | 95 | -140.89 | 111.39 | Superiority |
| Mean Difference (Final Values) |
| 2.44 |
| 2-Sided |
| 95 |
| -13.83 |
| 18.70 |
| Superiority |
| ANCOVA | 0.3776 | Mean Difference (Final Values) | 6.88 | 2-Sided | 95 | -8.65 | 22.41 | Superiority |
| Mean Difference (Final Values) |
| -5.27 |
| 2-Sided |
| 95 |
| -16.61 |
| 6.07 |
| Superiority |
| ANCOVA | 0.3294 | Mean Difference (Final Values) | 5.75 | 2-Sided | 95 | -5.99 | 17.49 | Superiority |
| Mean Difference (Final Values) |
| -2.07 |
| 2-Sided |
| 95 |
| -16.16 |
| 12.02 |
| Superiority |
| ANCOVA | 0.6306 | Mean Difference (Final Values) | 3.09 | 2-Sided | 95 | -9.74 | 15.91 | Superiority |
| Mean Difference (Final Values) |
| -0.64 |
| 2-Sided |
| 95 |
| -17.98 |
| 16.71 |
| Superiority |
| ANCOVA | 0.4508 | Mean Difference (Final Values) | 5.45 | 2-Sided | 95 | -8.96 | 19.86 | Superiority |