The Effects of Rosuvastatin on Running Training Adaptation and Safety (NCT07401017) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Effects of Rosuvastatin on Running Training Adaptation and Safety
Taiwan40 participantsStarted 2026-03-01
Plain-language summary
Statins lower low-density lipoprotein cholesterol (LDL-C) and help prevent atherosclerotic cardiovascular disease, but some users develop statin-associated muscle symptoms (SAMS) such as soreness, stiffness, weakness, or elevated creatine kinase (CK). These symptoms may be more noticeable during exercise. Regular long-distance running improves cardiopulmonary fitness-VO₂max, aerobic threshold (AT), and respiratory compensation point (RCP)-mainly through mitochondrial and metabolic adaptations. Prior studies suggest that lipophilic statins like simvastatin may blunt these adaptations, while hydrophilic statins such as rosuvastatin may have a smaller impact. However, prospective data in habitual endurance runners are limited.
This randomized controlled trial will examine how rosuvastatin affects cardiopulmonary fitness improvements and muscle tolerance in individuals who run at least three times per week and meet clinical criteria for statin therapy. After informed consent and baseline cardiopulmonary exercise testing (CPET), participants will be randomized to rosuvastatin 10 mg daily or no statin therapy for three months. Both groups will maintain their usual training routines, and training load will be recorded using heart-rate-based TRIMP. CPET will be repeated monthly to assess changes in VO₂max, AT, and RCP, and muscle enzymes and SAMS will be evaluated at each visit.
The study aims to clarify whether rosuvastatin influences endurance-related physiological adaptations or increases muscle symptoms in regular long-distance runners.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years.
* Meets clinical criteria for statin therapy, including at least one of the following:
* Family history of hyperlipidemia.
* LDL-C ≥ 160 mg/dL.
* 10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk ≥ 7.5%
* Diabetes mellitus with LDL-C ≥ 70 mg/dL.
* Determined by a clinician to require lipid-lowering therapy.
* Currently using or eligible to initiate rosuvastatin therapy.
* Performs long-distance running at least 3 times per week and is willing to maintain regular training for 3 months.
* Able and willing to undergo cardiopulmonary exercise testing (CPET) and to record training data using a sports watch (for TRIMP calculation).
* No known drug allergies and provides written informed consent after study explanation.
Exclusion Criteria:
* Known allergy or intolerance to statins or rosuvastatin.
* History of severe statin-related adverse events, including rhabdomyolysis or marked creatine kinase (CK) elevation.
* Liver dysfunction with AST or ALT \> 3× upper limit of normal.
* Moderate to severe renal impairment (eGFR \< 30 mL/min/1.73 m²).
* Current lower-limb pain, tendon injury, or other conditions that prevent running training.
* Not suitable for maximal cardiopulmonary exercise testing (CPET), such as unstable angina, uncontrolled hypertension, or recent cardiovascular events.
* Pregnant or breastfeeding.
* Inability to comply with study procedures, including use of a sports watch, regular follow-up visits, or maintaining run…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.