NIRS to Diagnose SAMS

Status unconfirmed · Phase 4 · Has a placebo group

Conditions studied: Statin Adverse Reaction, Skeletal Myopathy

In brief

This proposal seeks to determine whether near infrared spectroscopy (NIRS) can differentiate between patients with confirmed SAMS and those with non-specific muscle complaints. NIRS is a non-invasive technique of assessing skeletal muscle tissue oxygenation and mitochondrial function. Mitochondrial dysfunction is a possible cause of SAMS, but NIRS has never been evaluated as a diagnostic tool for SAMS. Investigators will enroll 40 patients with a history of SAMS in an 8 wk randomized, double-blind crossover trial of simvastatin 20 mg/d and placebo separated by a 4 wk washout phase. Tissue oxygenation will be measured using NIRS during a short handgrip exercise protocol before and after each treatment period. Investigators will query patients about muscle complaints weekly during both phases of the study with a validated survey to assess muscle pain. Investigators will classify patients as testing positive for SAMS if they report pain on simvastatin and not placebo. Investigators hypothesize that these patients, vs. patients experiencing pain on both treatments, placebo, or neither treatment, will be distinguished by reduced tissue oxygenation during simvastatin treatment relative to placebo, demonstrating efficacy of NIRS as a clinical tool that can be eventually used for the diagnosis and ultimately treatment of SAMS.

Key facts

Study ID

NCT03653663

Run by

Hartford Hospital

People needed

40

Starts

2018-01-01

Expected to finish

2020-07-30

Last updated by the study team

2020-02-13

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects >40 years of age, equal numbers of age, with a prior history of statin-associated muscle symptoms (SAMS). Subjects will be considered to have had prior statin related complaints and recruited for participation in the study if the following occurred: 1) They developed new pain, cramps, or muscle aching during statin treatment; 2) The symptoms resolved within 4 weeks of stopping the statin; 3) The identical symptoms recurred during repeat statin exposure.

You may not qualify if…

• Subjects who have had cancer within 5 years of entry, have hepatic disease (ALT > 2 times normal) or renal disease (creatinine > 2 mg/L) since these patients may require more careful monitoring during the study and would be best managed in a totally clinical setting
• Subjects presently treated with other medications known to alter statin metabolism;
• Subjects with hypo- or hyperthyroidism defined as a TSH > 5 or <0.01 IU/L since these conditions are known to be associated with statin intolerance and muscle weakness, respectively;1,2
• Subjects with hepatic dysfunction evidenced by a baseline alanine aminotransferase (ALT) level > 2 UNL;1,2
• Subjects with renal dysfunction defined as a baseline creatinine > 2mg/dl;
• Subjects with physical disabilities prohibiting the handgrip protocol;
• Women who are pregnant as determined by a urine pregnancy test using an Accutest Early Pregnancy Test Kit, or who are trying to become pregnant, and/or who have not been using a form of birth control for at least the last 3 months, since the impact of statins on pregnancy-related outcomes has not been well studied;1
• Subjects who regularly use corticosteroids or other drugs known to affect skeletal muscle metabolism or regularly have intramuscular injections that will affect CK levels.
• Subjects who are unwilling to limit their alcohol intake to an average of two or less drinks daily.

Where it is running

• Hartford Hospital — Hartford, Connecticut, United States
• University of Connecticut — Storrs, Connecticut, United States

Full record on ClinicalTrials.gov

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