Anthracycline Induced CardiotoxicityPhase 4NCT02053974
Spironolactone Against Anthracycline-induced Cardiomyopathy
A Phase 4 study testing Spironolactone in people with Anthracycline Induced Cardiotoxicity, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This study sought to investigate the whether spironolactone protects the heart against anthracycline-induced cardiotoxicity. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Anthracycline Induced Cardiotoxicity
- What is being tested?
- Spironolactone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2011to Oct 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LVEF >50%
- first diagnosed breast cancer
- female sex
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University School of Medicine
Kayseri, 38039
About this study
Official title: Protective Effects of Spironolactone Against Anthracycline Induced Cardiomyopathy
This study sought to investigate the whether spironolactone protects the heart against anthracycline-induced cardiotoxicity.
Read the 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.
- Conditions
- Anthracycline Induced Cardiotoxicity
- Being tested
- Spironolactone, Placebo
- Keywords
- Anthracycline, spironolactone, cardiotoxicity
- Medical subject headings
- Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpironolactoneDrug
Also called 25 mg spironolactone orally
Spironolactone
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Spironolactone | Active comparator | patients who randomized to spironolactone administered arm Receives: Drug: Spironolactone |
| Placebo | Placebo comparator | Patients who randomized to placebo administered arm Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in left ventricular ejection fraction
Measured: 24 weeks on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startSep 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anthracycline Induced CardiotoxicityStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmut Akpek, TC Erciyes University
- Investigators
- Mahmut Akpek, M.D., Principal investigator, Erciyes University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053974
- Sponsor's protocol ID
- Makpek-1
- Status last verified
- Feb 2014
- First submitted
- 30 Jan 2014
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25410653
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Effects of Spironolactone Against Anthracycline Induced Cardiomyopathy
- ClinicalTrials.gov ID
- NCT02053974
- Acronym / sponsor ID
- Makpek-1
- Conditions
- Anthracycline Induced Cardiotoxicity
- Keywords
- Anthracycline, spironolactone, cardiotoxicity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 4 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spironolactone | Active comparator | Drug: Spironolactonepatients who randomized to spironolactone administered arm |
| Placebo | Placebo comparator | Other: PlaceboPatients who randomized to placebo administered arm |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- LVEF >50%
- first diagnosed breast cancer
- female sex
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpironolactoneAlso: 25 mg spironolactone orallySpironolactone | Drug | Spironolactone |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Decrease in left ventricular ejection fraction
Time frame: 24 weeks on average
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2014.
- Derived from this study: PubMed 25410653Akpek 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmut Akpek, M.D. principal investigator
Erciyes University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spironolactone in people with Anthracycline Induced Cardiotoxicity, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in left ventricular ejection fraction (time frame: 24 weeks on average). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02053974, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2014.