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Prevention of Chemotherapy-induced Cardiotoxicity in High-risk Patients

Prevention of Chemotherapy-induced Cardiotoxicity in High-risk Patients

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00292526
Enrollment
114
Registered
2006-02-16
Start date
2000-11-30
Completion date
2011-11-30
Last updated
2017-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiotoxicity, Chemotherapeutic Toxicity

Keywords

Chemotherapy induced cardiotoxicity, Troponin, Heart failure

Brief 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). 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.

Interventions

DRUGEnalapril

enalapril orally administered

Sponsors

European Institute of Oncology
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Consecutive patients undergoing high-dose chemotherapy showing early release of Troponin I

Exclusion criteria

* Contraindication to ACE-inhibitors * On-going therapy with beta-blockers, ACE-inhibitors, angiotensin-receptors blockers

Design outcomes

Primary

MeasureTime frame
Incidence of chemotherapy-induced cardiotoxicity12 month period

Secondary

MeasureTime frame
Major adverse cardiac events, including death.12 month period

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026