Spironolactone Against Anthracycline-induced Cardiomyopathy
Protective Effects of Spironolactone Against Anthracycline Induced Cardiomyopathy
1 other identifier
interventional
90
1 country
1
Brief Summary
This study sought to investigate the whether spironolactone protects the heart against anthracycline-induced cardiotoxicity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2011
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 30, 2014
CompletedFirst Posted
Study publicly available on registry
February 4, 2014
CompletedFebruary 4, 2014
February 1, 2014
1.1 years
January 30, 2014
February 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Decrease in left ventricular ejection fraction
24 weeks on average
Study Arms (2)
Spironolactone
ACTIVE COMPARATORpatients who randomized to spironolactone administered arm
Placebo
PLACEBO COMPARATORPatients who randomized to placebo administered arm
Interventions
Eligibility Criteria
You may qualify if:
- LVEF \>50%
- first diagnosed breast cancer
- female sex
You may not qualify if:
- Prior breast cancer and/or prior anthracycline exposure history
- LVEF \<50%
- Use of angiotensin converting enzyme inhibitors, angiotensin receptor blockers and beta blockers
- Creatinin value \>2 mg/dl
- Presence of chronic kidney failure
- Potassium value \>5.3 mg/dl
- Presence of adrenal gland diseases,
- Presence of severe liver failure
- Co-morbidities such as coronary heart disease, hypertension, atrial fibrillation, and valvular heart disease.
- Male patients were excluded for the homogenization of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erciyes University School of Medicine
Kayseri, 38039, Turkey (Türkiye)
Related Publications (1)
Akpek M, Ozdogru I, Sahin O, Inanc M, Dogan A, Yazici C, Berk V, Karaca H, Kalay N, Oguzhan A, Ergin A. Protective effects of spironolactone against anthracycline-induced cardiomyopathy. Eur J Heart Fail. 2015 Jan;17(1):81-9. doi: 10.1002/ejhf.196. Epub 2014 Nov 20.
PMID: 25410653DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mahmut Akpek, M.D.
Erciyes University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical doctor of Cardiology department
Study Record Dates
First Submitted
January 30, 2014
First Posted
February 4, 2014
Study Start
September 1, 2011
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
February 4, 2014
Record last verified: 2014-02