Prevention of Chemotherapy-induced Cardiotoxicity in High-risk Patients

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.

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Key information

Conditions

Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Chemotherapeutic Toxicity Drug-Related Side Effects and Adverse Reactions Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

European Institute of Oncology

Milan, 20141, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enalapril

Drug

enalapril orally administered

Primary outcomes

Incidence of chemotherapy-induced cardiotoxicity

Time frame: 12 month period

Secondary outcomes

Major adverse cardiac events, including death.

Time frame: 12 month period

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Important dates

Study start: 2000
Primary completion: 2011
Study completion: 2011
First posted: Feb 16, 2006
Registry last updated: Feb 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed