STOP-CA (Statins TO Prevent the Cardiotoxicity From Anthracyclines)

Heart Failure Clinical Trial

Official title:

STOP-CA (Statins TO Prevent the Cardiotoxicity From Anthracyclines)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02943590
• Other study ID #: 16-440
• Status: Completed
• Phase: Phase 2
• Start date: January 13, 2017
• Est. completion date: October 11, 2023

Study information

• Verified date: November 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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"

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 11, 2023
• Est. primary completion date: September 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiotoxicity
• Heart Failure

Intervention

Drug:
• Placebo
A pill taken once a day
• Atorvastatin
A pill taken once a day

Locations

Country	Name	City	State
Canada	McGill University Health Center	Toronto
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts general Hospital	Boston	Massachusetts
United States	University of Pennsylvania Medical System	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Brigham and Women's Hospital, Dana-Farber Cancer Institute

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Percentage of Individuals in Each Group With a Significant Decline in the LVEF.	To determine if the administration of statins is associated with a lower percentage of individuals who experience a significant decline in the LVEF at 12 months. The primary outcome was the percentage of participants with an absolute decline in left ventricular ejection fraction (LVEF) of>10% from prior to chemotherapy to a final value of <55% over 12 months.	12 months
Secondary	The Percentage of Participants in Each Group With New Onset Heart Failure.	To determine whether statins reduce the percentage of participants in each group with new onset heart failure after anthracyclines.	2 years
Secondary	Myocardial Extracellular Volume by Cardiac MRI.	To determine if anthracyclines lead to an increase in myocardial fibrosis, myocardial extracellular volume, as measured by cardiac MRI and whether statins attenuate the increase in myocardial fibrosis.	1 Year
Secondary	Global Longitudinal Strain	To determine whether anthracyclines lead to a reduction in global longitudinal strain (GLS), whether the reduction in GLS associates with the decline in LVEF and whether statins attenuate the anthracycline-associated reduction in GLS.	1 Year
Secondary	Troponin	To determine if anthracyclines lead to an increase in serum troponin, to determine if the increase in serum troponin related to the decline in cardiac function and whether statins attenuate the increase in serum troponin.	1 year