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Spironolactone Against Anthracycline-induced Cardiomyopathy

Primary Purpose

Anthracycline Induced Cardiotoxicity

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Spironolactone
Placebo
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anthracycline Induced Cardiotoxicity focused on measuring Anthracycline, spironolactone, cardiotoxicity

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • LVEF >50%
  • first diagnosed breast cancer
  • female sex

Exclusion Criteria:

  • 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

Sites / Locations

  • Erciyes University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Spironolactone

Placebo

Arm Description

patients who randomized to spironolactone administered arm

Patients who randomized to placebo administered arm

Outcomes

Primary Outcome Measures

Decrease in left ventricular ejection fraction

Secondary Outcome Measures

Full Information

First Posted
January 30, 2014
Last Updated
February 1, 2014
Sponsor
TC Erciyes University
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1. Study Identification

Unique Protocol Identification Number
NCT02053974
Brief Title
Spironolactone Against Anthracycline-induced Cardiomyopathy
Official Title
Protective Effects of Spironolactone Against Anthracycline Induced Cardiomyopathy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study sought to investigate the whether spironolactone protects the heart against anthracycline-induced cardiotoxicity.
Detailed Description
Anthracyclines are the cornerstone in the treatment of numerous hematological and solid cancers. The most common side effect of anthracycline is cardiotoxicity and this may limits its use and increases the rate of mortality and morbidity. Cardiotoxicity is cumulative, dose dependent, and irreversible. Improvements in protective mechanisms against the cardiotoxicity of anthracycline are important to prevent the discontinuance of these chemotherapeutics. Spironolactone is an aldosterone antagonist which blocks the last step of the rennin angiotensin aldosterone system (RAAS). The RAAS is one of the most effective systems in remodeling of the myocardium in post-myocardial damage. According to the RALES study, in patients with severe heart failure, 25 mg spironolactone per day in addition to the standard therapy has positive effects, particularly on cardiac fibrosis and on remodeling, and substantially reduces the risk of both morbidity and death. In the EPHESUS study, it has been shown that, after the myocardial damage due to infarction, the administration of aldosterone antagonists had positive effects on the remodeling process, left ventricular ejection fraction and primer end-points. In the present study, we tested the hypothesis that RAAS blockage with spironolactone may reduce the cardiotoxicity of anthracycline group chemotherapeutics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anthracycline Induced Cardiotoxicity
Keywords
Anthracycline, spironolactone, cardiotoxicity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spironolactone
Arm Type
Active Comparator
Arm Description
patients who randomized to spironolactone administered arm
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients who randomized to placebo administered arm
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Other Intervention Name(s)
25 mg spironolactone orally
Intervention Description
Spironolactone
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Decrease in left ventricular ejection fraction
Time Frame
24 weeks on average

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: LVEF >50% first diagnosed breast cancer female sex Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmut Akpek, M.D.
Organizational Affiliation
Erciyes University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erciyes University School of Medicine
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
25410653
Citation
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.
Results Reference
derived

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Spironolactone Against Anthracycline-induced Cardiomyopathy

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