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Statins for the Primary Prevention of Heart Failure in Patients Receiving Anthracycline Pilot Study

NCT03186404 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2022-02-08

No results posted yet for this study

Summary

Anthracycline (AC) chemotherapy has substantially reduced the mortality rate from several common cancers globally. Unfortunately, AC treatment is associated with up to 19% risk of heart failure (HF). Current standard of care for preventing AC induced HF (AIHF) is cardiac surveillance followed by initiation of treatment once HF is diagnosed. With this approach 89% of patients fail to recover heart function and 46% will experience adverse cardiac events. Therefore there is a need for effective preventive therapy to reduce the risk of AIHF. Based on small human studies, animal studies, and our own pilot data, statins are an ideal class of drug for this purpose.

We will conduct a pilot double blinded, placebo controlled, randomized controlled trial to assess whether pre-treatment with statins before AC can prevent heart dysfunction. Eligible patients with cardiovascular risk factors scheduled to receive AC will be recruited. They will be randomized to statin therapy or placebo and followed until the end of cancer treatment. Primary outcome is the difference in cardiac MRI-determined left ventricular ejection fraction between pre-AC and end of treatment.

Conditions

Interventions

DRUG

Atorvastatin

Atorvastatin 40mg OD

DRUG

Placebo oral tablet

Placebo

Sponsors & Collaborators

  • Mount Sinai Hospital, Canada

    collaborator OTHER

  • Unity Health Toronto

    collaborator OTHER

  • Sunnybrook Health Sciences Centre

    collaborator OTHER

  • Scarborough General Hospital

    collaborator OTHER

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Paaladinesh Thavendiranathan · University Health Network, Toronto

  • Eitan Amir · University Health Network, Toronto

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-10
Primary Completion
2021-12-21
Completion
2023-12-31

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03186404 on ClinicalTrials.gov