CardiotoxicityPhase 4NCT00292526
Prevention of Chemotherapy-induced Cardiotoxicity in High-risk Patients
A Phase 4 study testing Enalapril in people with Cardiotoxicity and Chemotherapeutic Toxicity, run by European Institute of Oncology at 1 site in Italy.
Trial summary
In cancer patients, the increase of troponin I soon after chemotherapy is a strong predictor of left ventricular dysfunction and poor cardiologic outcome. This information provides a rationale for the development of prophylactic strategies directed against chemotherapy-induced cardiotoxicity (CTIC). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiotoxicity, Chemotherapeutic Toxicity
- What is being tested?
- Enalapril
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2000to Nov 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive patients undergoing high-dose chemotherapy showing early release of Troponin I
Who cannot join
- Contraindication to ACE-inhibitors
- On-going therapy with beta-blockers, ACE-inhibitors, angiotensin-receptors blockers
Trial locations and contacts
1 site in 1 country.
About this study
In cancer patients, the increase of troponin I soon after chemotherapy is a strong predictor of left ventricular dysfunction and poor cardiologic outcome. This information provides a rationale for the development of prophylactic strategies directed against chemotherapy-induced cardiotoxicity (CTIC). Activation of the renin-angiotensin system has been proved to be involved in the development and progression of cardiac dysfunction in several clinical settings, and has been suggested to have a role in the occurrence of CTIC. We investigated the role of treatment with ACE-inhibitors in the prevention of CTIC in high-risk cancer patients.
- Conditions
- Cardiotoxicity, Chemotherapeutic Toxicity
- Being tested
- Enalapril
- Keywords
- Chemotherapy induced cardiotoxicity, Troponin, Heart failure
- Medical subject headings
- Cardiotoxicity, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnalaprilDrug
enalapril orally administered
| Study group | Role | What they receive |
|---|---|---|
| enalapril arm | Experimental | treatment with enalapril Receives: Drug: Enalapril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of chemotherapy-induced cardiotoxicity
Measured: 12 month period
Secondary outcomes (1)
Major adverse cardiac events, including death.
Measured: 12 month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2006 (estimated)
- Study startNov 2000
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CardiotoxicityStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlo M Cipolla, MD, Study director, European Institute of OncologyDaniela Cardinale, MD, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292526
- Sponsor's protocol ID
- IEO S67/500
- Status last verified
- Feb 2017
- First submitted
- 15 Feb 2006
- Last updated
- 9 Feb 2017
- Results posted
- No
- Individual data sharing
- No
Publications
Cardinale D, Sandri MT, Colombo A, Colombo N, Boeri M, Lamantia G, Civelli M, Peccatori F, Martinelli G, Fiorentini C, Cipolla CM. Prognostic value of troponin I in cardiac risk stratification of cancer patients undergoing high-dose chemotherapy. Circulation. 2004 Jun 8;109(22):2749-54. doi: 10.1161/01.CIR.0000130926.51766.CC. Epub 2004 May 17.
PubMed 15148277Cardinale D, Sandri MT, Martinoni A, Tricca A, Civelli M, Lamantia G, Cinieri S, Martinelli G, Cipolla CM, Fiorentini C. Left ventricular dysfunction predicted by early troponin I release after high-dose chemotherapy. J Am Coll Cardiol. 2000 Aug;36(2):517-22. doi: 10.1016/s0735-1097(00)00748-8.
PubMed 10933366
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Chemotherapy-induced Cardiotoxicity in High-risk Patients
- ClinicalTrials.gov ID
- NCT00292526
- Acronym / sponsor ID
- IEO S67/500
- Conditions
- Cardiotoxicity, Chemotherapeutic Toxicity
- Keywords
- Chemotherapy induced cardiotoxicity, Troponin, Heart failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- Nov 2000 (actual)
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 16 Feb 2006 (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.
In cancer patients, the increase of troponin I soon after chemotherapy is a strong predictor of left ventricular dysfunction and poor cardiologic outcome. This information provides a rationale for the development of prophylactic strategies directed against chemotherapy-induced cardiotoxicity (CTIC). Activation of the renin-angiotensin system has been proved to be involved in the development and progression of cardiac dysfunction in several clinical settings, and has been suggested to have a role in the occurrence of CTIC. We investigated the role of treatment with ACE-inhibitors in the prevention of CTIC in high-risk cancer patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| enalapril arm | Experimental | Drug: Enalapriltreatment with enalapril |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive patients undergoing high-dose chemotherapy showing early release of Troponin I
Key exclusion criteria (2 listed)
- Contraindication to ACE-inhibitors
- On-going therapy with beta-blockers, ACE-inhibitors, angiotensin-receptors blockers
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 |
|---|---|---|
| Enalaprilenalapril orally administered | Drug | enalapril arm |
Primary outcome
Incidence of chemotherapy-induced cardiotoxicity
Time frame: 12 month period
1 secondary outcome
Major adverse cardiac events, including death.
Time frame: 12 month period
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 9 Feb 2017.
- Background: PubMed 15148277Cardinale D, Sandri MT, Colombo A, Colombo N, Boeri M, Lamantia G, Civelli M, Peccatori F, Martinelli G, Fiorentini C, Cipolla CM. Prognostic value of troponin I in cardiac risk stratification of cancer patients undergoing high-dose chemotherapy. Circulation. 2004 Jun 8;109(22):2749-54. doi: 10.1161/01.CIR.0000130926.51766.CC. Epub 2004 May 17.
- Background: PubMed 10933366Cardinale D, Sandri MT, Martinoni A, Tricca A, Civelli M, Lamantia G, Cinieri S, Martinelli G, Cipolla CM, Fiorentini C. Left ventricular dysfunction predicted by early troponin I release after high-dose chemotherapy. J Am Coll Cardiol. 2000 Aug;36(2):517-22. doi: 10.1016/s0735-1097(00)00748-8.
- Individual participant dataSharing planned: No
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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.
Carlo M Cipolla, MD study director
European Institute of Oncology
Daniela Cardinale, MD principal investigator
European Institute of Oncology
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 Enalapril in people with Cardiotoxicity and Chemotherapeutic Toxicity, run by European Institute of Oncology at 1 site in Italy.
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 1 inclusion and 2 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 9 Feb 2017. 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 Italy. 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. 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?
Incidence of chemotherapy-induced cardiotoxicity (time frame: 12 month period). 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 NCT00292526, which also lists 2 linked publications.
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 9 Feb 2017.