RecruitingPhase 2ACTRN12619000423112

The STAR-PAD trial is testing a new treatment for Peripheral Arterial Disease (PAD).

STimulating ß3 Adrenergic Receptors to improve change in exercise performance on a graded treadmill in patients with Peripheral Arterial Disease.

Sponsor

North Sydney Local Health District

Enrollment

100 participants

Start Date

Mar 14, 2019

Study Type

Interventional

Conditions

Peripheral Arterial Disease

Summary

STAR-PAD trial intend to answer the question of: Does the ß3AR agonist Mirabegron (50 mg/day), administered for 12 weeks, improve lower limb perfusion and intermittent claudication in patients with PAD compared with placebo control? The intervention will be oral tablet Mirabegron 50mg/day for 12 weeks vs Placebo, The primary outcome will be improvement in peak walk time (PWT) on a graded treadmill test

Eligibility

Sex: Both males and femalesMin Age: 40 Yearss

Plain Language Summary

Simplified for easier understanding

Peripheral arterial disease (PAD) is a condition where narrowed arteries reduce blood flow to the legs. This commonly causes intermittent claudication — cramping leg pain when walking that goes away with rest. It can significantly limit your ability to walk and exercise, affecting your daily life and overall health. This trial tests whether mirabegron (a medication normally used for overactive bladder) can improve blood flow and walking ability in people with PAD. Mirabegron works on receptors in blood vessels that may help them widen, increasing blood flow to the legs. Participants take either mirabegron 50mg or a placebo tablet daily for 12 weeks, and their walking ability on a treadmill is measured before and after. You may be eligible if you are aged 40 or over, have been diagnosed with PAD, experience stable leg pain when walking, and can walk on a treadmill for at least one minute. You are not eligible if you have severe leg disease (like ulcers or rest pain), had a heart attack or artery procedure in the last three months, or have uncontrolled high blood pressure.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

(1) Initial therapy with Mirabegron (50 mg/day) for 12 weeks. -Mirabegron (produced by Astellas Pharmaceuticals) is a film-coated prolonged release oral tablet and it will be administered at a dose o

(1) Initial therapy with Mirabegron (50 mg/day) for 12 weeks. -Mirabegron (produced by Astellas Pharmaceuticals) is a film-coated prolonged release oral tablet and it will be administered at a dose of 50 mg/day. OR (2) Placebo Strategies used to monitor adherence to the intervention: -At 4 weeks and 12 weeks participants will be self-reporting medication adherence (patient diary). -Participants will be instructed to return unused capsules at 12 weeks and returned capsules will be counted by the study team and returned to Pharmacy department at RNSH -Blood tests through the whole study (Screening, baseline, Week 4, Week 12).