Metabolic and Mitochondrial Changes in Statin-Induced Myopathy (NCT07511686) | Clinical Trial Compass
CompletedNot Applicable
Metabolic and Mitochondrial Changes in Statin-Induced Myopathy
Latvia38 participantsStarted 2023-08-22
Plain-language summary
The goal of this observational study is to learn whether statin-related muscle symptoms are linked to problems in fat metabolism in muscle cells, specifically involving acylcarnitines, in adults taking or not taking statins. The main questions it aims to answer are:
Do patients with statin-associated muscle symptoms have higher acylcarnitine levels in blood and muscle compared to statin users without symptoms and people not taking statins? Do acylcarnitine levels decrease after stopping or reducing statin treatment in affected patients?
Researchers will compare patients with statin-associated muscle symptoms, statin users without symptoms, and individuals not taking statins to see if differences in acylcarnitine levels and muscle metabolism are associated with muscle symptoms.
Participants will:
Provide blood samples for biochemical tests and acylcarnitine analysis Share information about their health, medications, and lifestyle (Optional) undergo a muscle biopsy to study muscle metabolism Some participants with muscle symptoms will have repeat blood tests and possibly a repeat muscle biopsy after statin dose reduction or discontinuation to track changes over time
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age at least 18 years.
✓. A representative of the Caucasian race.
✓. The patient agrees to participate in the study by signing an informed consent form for participation in the study. (The patient may only be included in the muscle biopsy sub-study if the relevant additional informed consent form has also been signed.)
✓. Specific inclusion criteria for each of the study subgroups:
✓. Group A: patients have elevated creatine kinase levels \>1.5x above the upper limit of normal (women \>325 U/L and men \>504 U/L) with or without muscle symptoms that have no other obvious explanation (including intense physical activity in the last 7 days).
✓. Group B: atorvastatin 40-80 mg or rosuvastatin 20-40 mg monotherapy for at least 8 weeks at a constant dose and no muscle symptoms (pain, weakness, fatigue, cramps) during this period, CK \<200 U/L.
✓. Group C: no lipid-lowering agents have been used during the last year and there have been no muscle symptoms (pain, weakness, fatigue, cramps) of unknown origin lasting \>1 week during this period, CK \<200 U/L.
✕. Any disease that, in the opinion of the investigator, could also cause a significant increase in CK or muscle symptoms.
✕. Use of other cholesterol-lowering agents specific to each of the study groups:
✕. Group A: use of red yeast rice extract, fibrates, or bempedoic acid within the last 8 weeks.
✕. Group B: use of other non-statin cholesterol-lowering agents (red yeast rice extract, ezetimibe, fibrates, PCSK9 inhibitors, inclisiran, bempedoic acid) in the last 8 weeks.
✕. Group C: use of any cholesterol-lowering agents (statins, red yeast rice extract, ezetimibe, fibrates, PCSK9 inhibitors, inclisiran, bempedoic acid) in the last 12 weeks.
✕. Intense physical activity in the last 7 days.
✕. Acute myocardial infarction or stroke in the last 4 weeks.
✕. Major surgery within the last 4 weeks (invasive cardiac procedures are not an exclusion criterion).