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HMG-CoA reductase inhibitor
Atorvastatin for Heart Failure in Patients Receiving Anthracycline (SPARE-HF Trial)
Phase 2
Waitlist Available
Led By Paaladinesh Thavendiranathan
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 4 weeks of anthracycline completion
Summary
This trial tests if taking atorvastatin before and during chemotherapy can prevent heart problems in cancer patients. It focuses on those with existing heart risk factors. Statins may help by reducing inflammation and protecting heart cells from damage caused by chemotherapy. Atorvastatin, a statin, is widely used to lower blood cholesterol and reduce cardiovascular disease risk, and recent studies suggest it may also help reduce heart problems in cancer patients undergoing chemotherapy.
Eligible Conditions
- Cardiotoxicity
- Heart Failure
- Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 4 weeks of anthracycline completion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 4 weeks of anthracycline completion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cardiac MRI measured LVEF within 4 weeks of anthracycline completion
Other study objectives
BNP
Cardiac MRI measured LV end diastolic volume (LVEDV) and end systolic volume (LVESV) at the end of treatment
Interruption of study drug due to side effects or permanent cessation of study drug or cancer treatment due to cardiac dysfunction
+4 moreSide effects data
From 2014 Phase 3 trial • 58 Patients • NCT020840693%
Postoperative bleeding
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment
Control
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: StatinExperimental Treatment1 Intervention
Atorvastatin 40mg
Group II: PlacebosPlacebo Group1 Intervention
Placebos
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atorvastatin
1998
Completed Phase 4
~10900
Find a Location
Who is running the clinical trial?
Mount Sinai Hospital, CanadaOTHER
204 Previous Clinical Trials
69,085 Total Patients Enrolled
Sunnybrook Health Sciences CentreOTHER
681 Previous Clinical Trials
1,565,646 Total Patients Enrolled
Unity Health TorontoOTHER
562 Previous Clinical Trials
453,839 Total Patients Enrolled
2 Trials studying Cardiotoxicity
385 Patients Enrolled for Cardiotoxicity
Scarborough General HospitalOTHER
10 Previous Clinical Trials
6,357 Total Patients Enrolled
University Health Network, TorontoLead Sponsor
1,531 Previous Clinical Trials
504,210 Total Patients Enrolled
5 Trials studying Cardiotoxicity
883 Patients Enrolled for Cardiotoxicity
Paaladinesh ThavendiranathanPrincipal InvestigatorUniversity Health Network, Toronto
Eitan AmirPrincipal InvestigatorUniversity Health Network, Toronto
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious problem with one of your heart valves causing it to be too narrow or leaky.You had a bad reaction to statin medication before.You are already taking statin medication or have a condition that requires statin treatment.Your creatine kinase (CK) level is more than three times the upper limit of normal.Your liver is not working properly, as shown by a certain blood test being higher than normal.You are taking a strong medication that affects how your body processes other drugs.You are expected to live for less than a year.You cannot have a cardiac MRI if you have a pacemaker, ICD, or other metal objects in your body that are not safe for an MRI, or if your kidney function is severely impaired.You have a high risk for heart problems based on certain criteria.You have a history of hypothyroidism that is not well controlled.Your creatinine levels are higher than 177 micromoles per liter.You have certain types of cancer that need treatment with a specific type of chemotherapy called anthracycline for a chance to cure the cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Placebos
- Group 2: Statin
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.