Cardiovascular Insufficiency / Anti-Cancer Agents / Cardiac Complication · Observational Study

Reporting, Evaluating, Preventing and Treating the Cardiotoxicity Induced by Anticancer Drugs During a Specific Cardio-oncology Consult and Follow up in Routine Care

ClinicalTrials.gov · September 11, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a prospective, multi-center observational study registered to evaluate cardiovascular complications of anticancer agents through structured cardio-oncology consultation and follow-up in routine French hospital care. No results are posted in this registry record; the study is still recruiting and outcomes will be assessed over a 5-year period.

What was studied

Observational. Cardiovascular Complication, Cardiovascular Insufficiency, Cardiac Complication, Oncologic Complications, Cardiac Insufficiency, Metabolic Disorder, Vascular D…; age from 18 Years. Intervention: Anti-Cancer Agents. n = 5,000. 3 sites: France.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

This study aims to characterize the frequency, severity, and outcomes of cardiotoxicity in routine oncology practice and to establish the benefit of structured cardio-oncology surveillance and intervention. Results, when available, may inform best practices for cardiotoxicity monitoring and prevention during cancer therapy.

Plain-language summary

This is a registry record for an observational study with no posted results; enrollment is ongoing and outcome data collection extends to 5 years, making it an early-phase implementation study.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measure: Number of patients having a benefit after this specific cardio-oncology check up and follow up (assessed at 5 years)

DesignObservational

PopulationCardiovascular Complication, Cardiovascular Insufficiency, Cardiac Complication, Oncologic Complications, Cardiac Insufficiency, Metabolic Disorder, Vascular D…; age from 18 Years

Sample size5,000

InterventionAnti-Cancer Agents

Setting3 sites: France

Reported figures

Quoted from the source exactly as published.

Planned enrollment5000

Primary outcome measureNumber of patients having a benefit after this specific cardio-oncology check up and follow up, 5 years

Study typeObservational

Follow-up duration5 years

Clinical bottom line

Caveats

Registry record only; no results posted and enrollment still ongoing.
No comparator or control group; observational design limits causal inference.
Primary outcome is subjective ('benefit'); operationalization and measurement strategy not detailed in registry.
Long-term follow-up (5 years) means results not yet available.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Observational design across multiple cardio-oncology centers; no randomization or comparator.

Directness

strong

Addresses cardiotoxicity detection and management in routine clinical care with real-world follow-up.

Consistency

insufficient

Registry record; no results posted; consistency cannot be assessed.

Risk of bias

insufficient

Observational design without control group; bias assessment deferred pending results.

Sample adequacy

moderate

Planned enrollment 5000 participants; appears adequate for descriptive and safety reporting.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT03882580). This is a study registration, not published results. Lead sponsor: Groupe Hospitalier Pitie-Salpetriere. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 5000 participants (ESTIMATED). Conditions: Cardiovascular Complication, Cardiovascular Insufficiency, Cardiac Complication, Oncologic Complications, Cardiac Insufficiency, Metabolic Disorder, Vascular Disorder, Cardiac Disorder. Interventions: DRUG: Anti-Cancer Agents. Primary outcome measures: Number of patients having a benefit after this specific cardio-oncology check up and follow up , 5 years. Brief summary: Several Drugs used in routine care in oncology induce rare but often severe or fatal cardiovascular or metabolic side effects. This study will investigate, evaluate, report and treat the cardiovascular side effects of anticancer drugs, through a specific cardiovascular routine checkup and follow-up taking place in several Cardio-oncology programs throughout France. The different including centers will be: Assistance Publique - Hôpitaux de Paris (APHP.6: Pitié-Salpétrière, Saint Antoine and Tenon's hospitals, Paris, France).

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Groupe Hospitalier Pitie-SalpetriereNCT03882580Cardiovascular InsufficiencyAnti-Cancer AgentsCardiac ComplicationCardiovascular Complication