Heart Failure Clinical Trial

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

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"

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

300

Study ID:

NCT02943590

Recruitment Status:

Active, not recruiting

Sponsor:

Massachusetts General Hospital

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There are 3 Locations for this study

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Massachusetts general Hospital
Boston Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
University of Pennsylvania Medical System
Philadelphia Pennsylvania, 19104, United States
McGill University Health Center
Toronto , , Canada

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

300

Study ID:

NCT02943590

Recruitment Status:

Active, not recruiting

Sponsor:


Massachusetts General Hospital

How clear is this clinincal trial information?

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