Prevention of Chemotherapy-induced Cardiotoxicity in High-risk Patients

NCT00292526 | Completed Phase 4

• 1 other identifier: IEO S67/500
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiotoxicity; Chemotherapeutic Toxicity

Keywords

Chemotherapy induced cardiotoxicity; Troponin; Heart failure

Outcome Measures

Primary Outcomes (1)

• Incidence of chemotherapy-induced cardiotoxicity

  12 month period

Secondary Outcomes (1)

• Major adverse cardiac events, including death.

  12 month period

Study Arms (1)

enalapril arm

EXPERIMENTAL

treatment with enalapril

Drug: Enalapril

Interventions

Enalapril DRUG

enalapril orally administered

enalapril arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, 20141, Italy

Location

Related Publications (2)

• 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.

  PMID: 15148277 BACKGROUND

• Cardinale 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.

  PMID: 10933366 BACKGROUND

MeSH Terms

Conditions

Cardiotoxicity; Heart Failure

Interventions

Enalapril

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Carlo M Cipolla, MD

  European Institute of Oncology

  STUDY DIRECTOR

• Daniela Cardinale, MD

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2006
• First Posted: February 16, 2006
• Study Start: November 1, 2000
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: February 9, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)