Clinical trial · Interventional
Prevention of Anthracycline-induced Cardiotoxicity
ICOS-ONE - Prevention of Anthracycline-induced Cardiotoxicity: a Multicentre Randomized Trial Comparing Two Therapeutic Strategies.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Anthracycline based anti-tumoral therapies are know to develop cardiac damage that could also lead to heart failure. Monocentric studies proved that a treatment with ACE inhibitors (ACEi) and betablockers (BB) during the first elevation of cardiac troponin is able to reduce the incidence of heart failure (HF). ICOS-ONE trial is a multicenter randomized trial comparing two therapeutic strategies. The main objective is to assess whether enalapril started concomitantly to AC-containing treatments, can prevent cardiac toxicity more effectively than when enalapril is prescribed to selected patients showing laboratory evidences of injury after chemotherapy, during follow-up visits in 268 patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enalapril | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Enalapril concomitant
- description
- Enalapril started concomitantly to AC-containing treatments
- interventionNames
- Drug: Enalapril
- type
- EXPERIMENTAL
- label
- Enalapril after injury
- description
- Enalapril prescribed to selected patients showing laboratory evidences of injury after chemotherapy at follow-up visits.
- interventionNames
- Drug: Enalapril
Primary outcomes (1)
- measure
- the occurrence of cTn elevation above the threshold in use at the local laboratory, at any time during the study
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with diagnosis of cancer and indication for first- and second-line therapy with anthracyclines 2. Age ≥18years 3. Serum creatinine\<177µmol/L(2mg/100mL) 4. Systolic blood pressure ≥100 mmHg and ≤170 mmHg 5. Left ventricular ejection fraction (VEF) \>50% 6. Written informed consent. 7. Life expectancy of at least 12 months Exclusion Criteria: 1. Patients with history or clinical/instrumental evidences of heart failure 2. Patients with history or clinical/instrumental evidences of ischemic heart disease; 3. Patients with blood troponin levels higher than the cut-off suggested by the manufacturer before starting cancer CT; 4. Systolic blood pressure\<100 mmHg; 5. Heart rate\<50 bpm; 6. Prior malignancy requiring potentially cardiotoxic chemotherapy (e.g. anthracyclines, trastuzumab..);; 7. Uncontrolled hypertension defined as systolic blood pressure\>170 mmHg; 8. Treatment with ACEi, ARB or BB within 4 weeks prior to study start; 9. Known intolerance to enalapril, except for cough; 10. Planned treatment with dexrazoxane; 11. Participation in another experimental drug trial within 4 weeks prior to study start; 12. Non-cooperative behaviour or suspected poor compliance; 13. Psychiatric disorders or conditions that might impair the ability to give informed consent; 14. Pregnancy or breast feeding; 15. Scheduled mediastinal radiotherapy.
References
Publications (0)
Data not yet available