Ignite Creation Date:
2024-05-06 @ 10:10 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03186404
Status:
UNKNOWN
Last Update Posted:
2022-02-08
First Post:
2017-06-09
Brief Title:
Statins for the Primary Prevention of Heart Failure in Patients Receiving Anthracycline Pilot Study
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Randomized Double Blind Placebo Controlled Trial of Statins for the Primary pREvention of Heart Failure in Patients With Cancer Receiving Anthracycline Based Chemotherapy
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPARE-HF
Brief 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
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
Detailed Description:
STUDY DESIGN This is a double blind placebo controlled randomized controlled trial RCT We will also use stratification to ensure that the proportion of patients with different malignancies is balanced between the study arms
PATIENT RECRUITMENT Patients will be recruited from respective oncology clinics at Princess Margaret Hospital Mount Sinai Hospital St Michaels Hospital Sunnybrook Health Sciences Centre and Scarborough General Hospital
INTERVENTION Patients will receive treatment with 40mgday of atorvastatin or placebo started 2-10 days prior to the initiation of AC and continued for up to one month after completion of the AC portion of cancer treatment
CARDIAC MRI CMR Studies will be performed on a 30T scanner Siemens and will include complete function and tissue characterization CMR studies will be performed pre-therapy after completion of AC and 2 years after completion of AC After de-identification and randomization a research assistant blinded to all clinical data will perform all CMR analysis using commercially available software
ECHOCARDIOGRAPHY Routine echocardiography studies will be performed at baseline post-anthracycline completion and at 6 months 1 year and 2 years follow up
SERUM BIOMARKERS Blood work will be obtained on the day of baseline imaging immediately after each cycle of anthracycline on the day of post treatment imaging and at the 6 months 1 year and 2 year follow up At each time point optional samples of bio-banking may be collected Blood sample collection will be done locally at the participants respective site and transferred to University Health Network UHN biobank for future analysis or analysis of markers that are not available at all sites eg high sensitivity troponin I and BNP
PATIENT RECRUITMENT Patients will be recruited from respective oncology clinics at Princess Margaret Hospital Mount Sinai Hospital St Michaels Hospital Sunnybrook Health Sciences Centre and Scarborough General Hospital
INTERVENTION Patients will receive treatment with 40mgday of atorvastatin or placebo started 2-10 days prior to the initiation of AC and continued for up to one month after completion of the AC portion of cancer treatment
CARDIAC MRI CMR Studies will be performed on a 30T scanner Siemens and will include complete function and tissue characterization CMR studies will be performed pre-therapy after completion of AC and 2 years after completion of AC After de-identification and randomization a research assistant blinded to all clinical data will perform all CMR analysis using commercially available software
ECHOCARDIOGRAPHY Routine echocardiography studies will be performed at baseline post-anthracycline completion and at 6 months 1 year and 2 years follow up
SERUM BIOMARKERS Blood work will be obtained on the day of baseline imaging immediately after each cycle of anthracycline on the day of post treatment imaging and at the 6 months 1 year and 2 year follow up At each time point optional samples of bio-banking may be collected Blood sample collection will be done locally at the participants respective site and transferred to University Health Network UHN biobank for future analysis or analysis of markers that are not available at all sites eg high sensitivity troponin I and BNP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None