A Study to Evaluate AuTophagy Activation for Cardiomyopathy Due to Anthracycline tReatment


NCT ID: NCT04190433
Sponsor Protocol Number: MC2014

About this study

The purpose of this study is to evaluate the additional benefit of pravastatin and spironolactone when given in combination with carvedilol and lisinopril versus carvedilol and lisinopril alone.


Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • ≥ 18 years of age.
  • New diagnosis of reduced cardiac function.
  • Within 12 months of anthracycline-based cancer therapy for hematological malignancy, breast cancer, or sarcoma

Exclusion Criteria:

  • History of HF of any class and type, or diagnosis of cardiomyopathy prior to anthracycline therapy.
  • On active therapy with a fibrate, niacin, or eplerenone.
  • History of myopathy/rhabdomyolysis.
  • History of statin intolerance.
  • Active treatment for hyperlipidemia.
  • History of gout.
  • Active treatment for liver disease.
  • Unexplained persistent elevations of serum transaminases (above upper limit of normal over two weeks).
  • Pregnancy.
  • Breast-feeding.
  • Hyperkalemia.
  • Addison disease.
  • eGFR < 30 mL/minute/1.73 m^2.

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