Clinical trial NCT02943590: STOP-CA (Statins TO Prevent the Cardiotoxicity From Anthracyclines)
Official title: STOP-CA (Statins TO Prevent the Cardiotoxicity From Anthracyclines)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Keywords: Cancer Treatment Related to Heart Failure
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
name: Brigham and Women's Hospital
First posted: 2016-10-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study will test whether atorvastatin, a drug commonly prescribed for reducing cholesterol levels, can protect the heart during chemotherapy with doxorubicin. Atorvastatin is from a family of medications that are commonly called "statins"

Detailed description: This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of a drug and determine whether the investigational drug works in treating a specific disease. "Investigational" means that the drug is being studied.

The chemotherapy drug that the participant have been scheduled to be treated with, Doxorubicin, has been associated with the development of heart failure in some patients.

This research study is testing whether Atorvastatin can protect the hearts of patients being treated with Doxorubicin and can reduce cardiac injury and the risk of heart failure. Atorvastatin is not approved by the FDA (the U.S. Food and Drug Administration) for use to reduce the cardiac injury after Doxorubicin. Atorvastatin is approved by the FDA for lowering cholesterol and for reducing the risk of heart attack and stroke. The heart is a muscle that pumps blood and Atorvastatin may protect the heart by preserving cardiac muscle function.

The investigators will test whether atorvastatin protects the heart using a combination of imaging tests on the participants heart, blood tests, and stress testing. The imaging tests will involve an echocardiogram (an echo) and cardiac magnetic resonance (CMR), a type of magnetic resonance imaging (MRI) scan.

Eligibility criteria: Inclusion Criteria:

* \> 18 years of age
* All patients with newly diagnosed NHL and HL
* Scheduled to receive anthracycline-based therapy

Exclusion Criteria:

* Statin use or Statin use is indicated based on guidelines
* Pregnancy or breastfeeding
* Unable to provide informed consent
* Unexplained persistent elevation of transaminases (\>3 times upper limits of normal)
* Concomitant use of cyclosporine
* Renal failure: estimated glomerular filtration \<45 mL/min/1.73 m2
* Contraindication to a CMR (metallic object, severe claustrophobia, pacemaker, vascular clip
* LVEF of \<50% at baseline

Primary outcomes:
measure: The Percentage of Individuals in Each Group With a Significant Decline in the LVEF.
timeFrame: 12 months
Secondary outcomes:
measure: The Percentage of Participants in Each Group With New Onset Heart Failure.
timeFrame: 2 years
measure: Myocardial Extracellular Volume by Cardiac MRI.
timeFrame: 1 Year
measure: Global Longitudinal Strain (GLS)
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts general Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Philadelphia
country: United States
facility: University of Pennsylvania Medical System
state: Pennsylvania
city: Toronto
country: Canada
facility: McGill University Health Center
Study officials:
affiliation: Massachusetts General Hospital
name: Tomas G Neilan, MD
role: PRINCIPAL_INVESTIGATOR
References: