NCT07401017

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress34%
Mar 2026Oct 2026

First Submitted

Initial submission to the registry

December 1, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

February 10, 2026

Status Verified

November 1, 2025

Enrollment Period

6 months

First QC Date

December 1, 2025

Last Update Submit

February 5, 2026

Conditions

DyslipidemiaLong-Distance RunningEndurance TrainingStatin-Associated Muscle Symptoms

Outcome Measures

Primary Outcomes (3)

  • VO₂max (mL/kg/min)

    Maximum oxygen consumption obtained from cardiopulmonary exercise testing (CPET). Used to assess changes in cardiopulmonary fitness over the 3-month intervention period.

    Baseline (Month 0), Month 1, Month 2, Month 3

  • Aerobic Threshold (AT)

    Aerobic threshold determined by standardized CPET. Represents the transition from aerobic to anaerobic metabolism during exercise.

    Baseline, Month 1, Month 2, Month 3

  • Respiratory Compensation Point (RCP)

    RCP measured via CPET, representing the ventilatory response to metabolic acidosis. Used to evaluate endurance training adaptation.

    Baseline, Month 1, Month 2, Month 3

Secondary Outcomes (4)

  • Calculated Training Load Score (using TRIMP method)

    Through the end of the 3-month intervention period

  • Number of Participants with Statin-Associated Muscle Symptoms (SAMS)

    Month 1, Month 2, and Month 3

  • Change from Baseline in Body Weight (kg)

    Baseline, Month 1, Month 2, Month 3

  • Change from Baseline in Body Mass Index (kg/m^2)

    Baseline, Month 1, Month 2, Month 3

Study Arms (2)

Rosuvastatin group

EXPERIMENTAL
Drug: Rosuvastatin

Control group

NO INTERVENTION

Interventions

RosuvastatinDRUG

Rosuvastatin 10 mg tablet taken orally once daily at bedtime for 3 months.

Rosuvastatin group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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 running training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei medical university

Taipei, 116, Taiwan

Location

Related Publications (8)

  • Sigrist C, Murner-Lavanchy I, Peschel SKV, Schmidt SJ, Kaess M, Koenig J. Early life maltreatment and resting-state heart rate variability: A systematic review and meta-analysis. Neurosci Biobehav Rev. 2021 Jan;120:307-334. doi: 10.1016/j.neubiorev.2020.10.026. Epub 2020 Nov 7.

    PMID: 33171141BACKGROUND

  • Glei M, Schlormann W. Analysis of DNA damage and repair by comet fluorescence in situ hybridization (Comet-FISH). Methods Mol Biol. 2014;1094:39-48. doi: 10.1007/978-1-62703-706-8_4.

    PMID: 24162978BACKGROUND

  • Yamada Y, Hoyano M, Akashi R, Oto K, Kanemitsu Y. Impact of Chemical Doping on Optical Responses in Bismuth-Doped CH3NH3PbBr3 Single Crystals: Carrier Lifetime and Photon Recycling. J Phys Chem Lett. 2017 Dec 7;8(23):5798-5803. doi: 10.1021/acs.jpclett.7b02508. Epub 2017 Nov 15.

    PMID: 29130309BACKGROUND

  • Najmeddin F, Khalili H. Comment on: Guidelines for the diagnosis and antibiotic treatment of endocarditis in adults: a report of the Working Party of the British Society for Antimicrobial Chemotherapy. J Antimicrob Chemother. 2012 Dec;67(12):3016-7; author reply 3017. doi: 10.1093/jac/dks290. Epub 2012 Jul 24. No abstract available.

    PMID: 22833643BACKGROUND

  • Tabit CE, Shenouda SM, Holbrook M, Fetterman JL, Kiani S, Frame AA, Kluge MA, Held A, Dohadwala MM, Gokce N, Farb MG, Rosenzweig J, Ruderman N, Vita JA, Hamburg NM. Protein kinase C-beta contributes to impaired endothelial insulin signaling in humans with diabetes mellitus. Circulation. 2013 Jan 1;127(1):86-95. doi: 10.1161/CIRCULATIONAHA.112.127514. Epub 2012 Nov 30.

    PMID: 23204109BACKGROUND

  • Park JS, Park D. Effect of Polydeoxyribonucleotide Injection in a Patient With Carpal Tunnel Syndrome. Am J Phys Med Rehabil. 2018 Oct;97(10):e93-e95. doi: 10.1097/PHM.0000000000000901.

    PMID: 29373371BACKGROUND

  • Hartiala O, Magnussen CG, Kajander S, Knuuti J, Ukkonen H, Saraste A, Rinta-Kiikka I, Kainulainen S, Kahonen M, Hutri-Kahonen N, Laitinen T, Lehtimaki T, Viikari JS, Hartiala J, Juonala M, Raitakari OT. Adolescence risk factors are predictive of coronary artery calcification at middle age: the cardiovascular risk in young Finns study. J Am Coll Cardiol. 2012 Oct 9;60(15):1364-70. doi: 10.1016/j.jacc.2012.05.045. Epub 2012 Sep 12.

    PMID: 22981553BACKGROUND

  • Mikus CR, Boyle LJ, Borengasser SJ, Oberlin DJ, Naples SP, Fletcher J, Meers GM, Ruebel M, Laughlin MH, Dellsperger KC, Fadel PJ, Thyfault JP. Simvastatin impairs exercise training adaptations. J Am Coll Cardiol. 2013 Aug 20;62(8):709-14. doi: 10.1016/j.jacc.2013.02.074. Epub 2013 Apr 10.

    PMID: 23583255BACKGROUND

MeSH Terms

Conditions

Dyslipidemias

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Yu-Hsuan Cheng, MD, MS

    Taipei Medical University

    STUDY CHAIR

Central Study Contacts

Yu-Hsuan Cheng, MD, MS

CONTACT

886-2-2930-7930 Ext. 1600heathcyh@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2025

First Posted

February 10, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

February 10, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)