Telmisartan Plus Exercise to Improve Functioning in Peripheral Artery Disease

  • STATUS
    Recruiting
  • End date
    Jun 22, 2023
  • participants needed
    112
  • sponsor
    Northwestern University
Updated on 22 August 2021
arteriopathy
exercise therapy
peripheral arterial diseases

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.

Details
Condition peripheral artery disease, Peripheral Arterial Disease (PAD), peripheral arterial diseases, peripheral arterial disease
Treatment Placebo, Telmisartan, Supervised Treadmill Exercise Therapy, "No exercise" control group
Clinical Study IdentifierNCT02593110
SponsorNorthwestern University
Last Modified on22 August 2021

Eligibility

Yes No Not Sure

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

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
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
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