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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 Eitan Amir
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
Patients with high cardiovascular risk as defined by specific criteria
Patients with one of the following malignancies requiring anthracycline based chemotherapy with a curative intent: breast cancer; aggressive lymphomas; leukemia (acute myelogenous leukemia, acute lymphoblastic leukemia, mixed phenotype acute leukemia) or; sarcoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 4 weeks of anthracycline completion
Awards & highlights

SPARE-HF Trial Summary

This trial will test whether statins can prevent heart failure from anthracycline chemotherapy.

Eligible Conditions
  • Cardiotoxicity
  • Heart Failure
  • Cancer

SPARE-HF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a high risk for heart problems based on certain criteria.
Select...
You have certain types of cancer that need treatment with a specific type of chemotherapy called anthracycline for a chance to cure the cancer.

SPARE-HF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 4 weeks of cancer therapy completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 4 weeks of cancer therapy completion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cardiac MRI measured LVEF within 4 weeks of anthracycline completion
Other outcome measures
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 more

Side effects data

From 2014 Phase 3 trial • 58 Patients • NCT02084069
3%
Postoperative bleeding
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment
Control

SPARE-HF 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
194 Previous Clinical Trials
67,292 Total Patients Enrolled
Unity Health TorontoOTHER
533 Previous Clinical Trials
446,351 Total Patients Enrolled
2 Trials studying Cardiotoxicity
385 Patients Enrolled for Cardiotoxicity
Sunnybrook Health Sciences CentreOTHER
651 Previous Clinical Trials
1,542,577 Total Patients Enrolled

Media Library

Atorvastatin (HMG-CoA reductase inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03186404 — Phase 2
Cardiotoxicity Research Study Groups: Placebos, Statin
Cardiotoxicity Clinical Trial 2023: Atorvastatin Highlights & Side Effects. Trial Name: NCT03186404 — Phase 2
Atorvastatin (HMG-CoA reductase inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03186404 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Atorvastatin been cleared by the FDA?

"While there is some data suggesting that Atorvastatin is safe, it is still in Phase 2 of clinical trials and has yet to be proven effective. Therefore, it received a score of 2."

Answered by AI

What issues has Atorvastatin been effective in treating in the past?

"Atorvastatin has been shown to decrease postoperative thromboembolism, anginal pain, and lipidemias."

Answered by AI

How many people are included as test subjects in this research?

"At the moment, this trial is not looking for any more participants. The trial was first posted on May 10th, 2018 and was last updated on February 4th, 2022. There are 1239 other studies that are actively recruiting patients with malignancies and 73 studies for Atorvastatin that are actively recruiting patients."

Answered by AI

Are there any more spots open for people who want to join this research project?

"Unfortunately, this particular clinical trial is not currently enrolling patients. The listing was first posted on May 10th, 2018 and was last edited on February 4th, 2022. However, there are 1239 other clinical trials for patients with malignancies and 73 trials for Atorvastatin that are actively recruiting patients."

Answered by AI

Does this type of clinical trial exist anywhere else in the world?

"Merck Sharp & Dohme LLC sponsored the first study of Atorvastatin in 2005, which involved 80 patients and completed Phase 4 drug approval. Since then, 527 studies have been conducted in 28 countries and 162 cities."

Answered by AI
~16 spots leftby Mar 2025