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Rechecking muscle symptoms from statins in adults with familial hypercholesterolemia

Compares atorvastatin, placebo and no treatment in adults with familial hypercholesterolemia and muscle symptoms.

Key facts

Who runs it
Oslo University Hospital HF
Where
Oslo and Trondheim, NorwaySee the 2 sites
Registry title
Reassessment of statin-associated muscle symptoms in adults with familial hypercholesterolemia
Status
Not yet recruiting
Phase
Phase 4
People taking part
70 people, planned
Started
3 Aug 2026
Expected to end
31 Dec 2028
Type of study
Interventional
Record updated
22 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with familial hypercholesterolemia who stopped statins because of muscle symptoms they link to statins.

Age
18 years or older
Sex
All sexes can join
Disease stage
Heterozygous familial hypercholesterolemia confirmed by genetic testing, or a clinical diagnosis with a Dutch Lipid Clinic Network Score of 9 or more
Earlier treatment
Muscle symptoms they link to statins on at least two different statins; stopped statin treatment because of these symptoms and off statins for at least 2 weeks before first assessment

Main reasons for not taking part

  • Hospitalized for an unplanned atherosclerotic cardiovascular event in the past 6 months
  • Creatine kinase 5 or more times the upper limit of normal at baseline
  • History of rhabdomyolysis or myopathy
  • Severe kidney problems in the last 12 months (eGFR below 30 mL/min/1.73m2)
  • Any contraindication to atorvastatin, including pregnancy and breastfeeding

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • Participant must be ≥18 years of age at the time of signing the informed consent
  • Participant having genetically verified diagnosis of heterozygous familial hypercholesterolemia or clinical diagnosis of familial hypercholesterolemia with Dutch Lipid Clinic Network Score ≥9
  • Participant with a history of self-perceived statin-associated muscle symptoms (i.e. muscle symptoms subjectively associated with statin treatment) on at least two different types of statins
  • Participant having discontinued statin treatment due to associated muscle symptoms (must have been off statin treatment for at least 2 weeks prior to first assessment for study inclusion)
  • If woman of childbearing potential (defined as all premenopausal female that are not permanently sterile); participant must take a pregnancy test with negative result and express willingness to highly effective contraceptive use or adequate sexual abstinence during the study intervention (until the end of intervention)
  • Participant expected to be compliant with the requirements and restrictions listed in the informed consent form and in the protocol
  • Participant having access to a smartphone, tablet or personal computer throughout the study
  • Participant capable of giving signed informed consent

Who cannot take part

  • Participant hospitalized for an unplanned atherosclerotic cardiovascular event the past 6 months prior to study
  • Participant currently using other drug(s) referred to as contraindicated during atorvastatin treatment, or not compatible with atorvastatin 80 mg, according to the Summary of Product Characteristics
  • Participant with short life expectancy (<24 months) due to other medical conditions
  • Participant with history of rhabdomyolysis
  • Participant with history of myopathy (creatine kinase ≥10 times upper limit of the normal range)
  • Participant with history of liver affection (alanine aminotransferase and/or aspartate aminotransferase ≥3 times upper limit of the normal range) associated with statin treatment
  • Participant with history of severe renal insufficiency last 12 months (estimated glomerular filtration rate < 30 mL/min/1.73m2)
  • Participant with any condition (e.g. psychiatric illness, dementia, substance abuse), that in the principal investigator’s opinion could put the subject at significant risk, confound the study results or interfere significantly with the subject participation in the study
  • Participant having any contraindication(s) for atorvastatin listed in the Summary of Product Characteristics (including known hypersensitivity to the ingredients, alanine aminotransferase ≥3 times upper limit of the normal range at baseline, pregnancy and breastfeeding)
  • Participant with elevated CK ≥5 times upper limit of the normal range at baseline
  • Participation in another interventional clinical study

Where in Norway

  • Oslo Universitetssykehus HFOslo, NorwayNot yet recruiting
  • St. Olavs hospital HFTrondheim, NorwayNot yet recruiting

About the trial

What the trial wants to find out

To determine the proportion of patients with statin-dependent muscle symptoms and nocebo/misattributed muscle symptoms among adults with familial hypercholesterolemia and self-perceived statin-associated muscle symptoms (SAMS).

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Reassessment of statin-associated musscle symptoms in adults with familial hypercholesterolemia: A phase IV randomized double-blinded n-of-1 crossover trial including periods with atorvastatin, placebo and no study treatment
Plain-language title
Rechecking muscle symptoms from statins in adults with familial hypercholesterolemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
22 May 2026