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RecruitingNCT03882580NEOCARDIOUpdated Sep 11, 2026

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

An observational study in Cardiovascular Complication, Cardiovascular Insufficiency and Cardiac Complication, sponsored by Groupe Hospitalier Pitie-Salpetriere. Recruiting at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Groupe Hospitalier Pitie-Salpetriere · Observational

From the registry’s dates

  • Started Mar 2019; still recruiting 7 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
18 Years and older
Sex
All
01

Study 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).

Read the detailed description

Several anticancer and supportive care drugs used in oncology have an impact on the cardiovascular and metabolic systems, leading to a wide range of cardiovascular and metabolic disorders and side effects. Those are poorly described, due to the evolution of the anticancer pharmacopeia, and recent recognition of these adverse events. This study will investigate the potential benefits of a specialized cardio-oncology check-up and follow-up in this context.

02

Conditions studied

  • Cardiovascular Complication
  • Cardiovascular Insufficiency
  • Cardiac Complication
  • Oncologic Complications
  • Cardiac Insufficiency
  • Metabolic Disorder
  • Vascular Disorder
  • Cardiac Disorder

Keywords

  • anticancer drugs
  • cardiac toxicities
  • cardiovascular prevention
  • vascular toxicities
  • metabolic toxicities
  • adverse drug reactions
03

In context

Heart Failure

6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 200 across 1,983 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere is the lead sponsor of 66 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients suffering (or having suffered) from a cancer

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Suffering a cancer
  • Evaluated within a cardio-oncology program

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Patient registry
No

Interventions

  • DrugAnti-Cancer Agents

    Drugs and treatments used in cancer inducing cardiovascular and metabolic side effects

06

What researchers measure

Primary outcomes

  1. Number of patients having a benefit after this specific cardio-oncology check up and follow up

    Time frame: 5 years

Secondary outcomes

  1. Evaluating the overall survival of patients suffering from cardiovascular or metabolic side effect of oncology treatments

    Time frame: 5 years

  2. All relevants staisticals associations between adverse events and anticancer drugs

    Time frame: 5 years

  3. All relevant statistical associations between cardiovascular toxicities, and anticancer drugs

    Time frame: 5 years

  4. All relevants statistical associations between cardiovascular side effects induced by oncology treatments , and other potentials kind of side effects induced by oncology treatments

    Time frame: 5 years

  5. All relevant statistical associations between duration and type of treatement used to manage cardiovascular side effects induced by oncology treatments, and overall survival

    Time frame: 5 years

  6. All relevants statistical associations between differential features of subgroups of patients, and the occurence of cardiovascular side effects induced by oncology treatments

    Time frame: 5 years

  7. All relevant statistical associations between new therapies to treat or prevent the cardiovascular side effects induced by oncology treatments, and overall survival

    Time frame: 5 years

  8. All relevant statistical associations between the pre therapeutic cardiovascular checkup and follow up for patients with cancer or history of cancer, and the occurence of cardiovascular toxicities of oncology treatments.

    Time frame: 5 years

  9. All relevant statistical associations between metabolic toxicities, and anticancer drugs

    Time frame: 5 years

  10. All relevants statistical associations between metabolic side effects induced by oncology treatments , and other potentials kind of side effects induced by oncology treatments

    Time frame: 5 years

  11. All relevant statistical associations between duration and type of treatement used to manage metabolic side effects induced by oncology treatments, and overall survival

    Time frame: 5 years

  12. All relevants statistical associations between differential features of subgroups of patients, and the occurence of metabloic side effects induced by oncology treatments

    Time frame: 5 years

  13. All relevant statistical associations between new therapies to treat or prevent the metabolic side effects induced by oncology treatments, and overall survival

    Time frame: 5 years

  14. All relevant statistical associations between the pre therapeutic metabolic checkup and follow up for patients with cancer or history of cancer, and the occurence of metabolic toxicities of oncology treatments.

    Time frame: 5 years

07

Study locations

3 of 3 sites recruiting
08

References and documents

Publications

  • Salem JE, Allenbach Y, Vozy A, Brechot N, Johnson DB, Moslehi JJ, Kerneis M. Abatacept for Severe Immune Checkpoint Inhibitor-Associated Myocarditis. N Engl J Med. 2019 Jun 13;380(24):2377-2379. doi: 10.1056/NEJMc1901677. No abstract available. PubMed 31189043 ↗
  • Dolladille C, Ederhy S, Allouche S, Dupas Q, Gervais R, Madelaine J, Sassier M, Plane AF, Comoz F, Cohen AA, Thuny FR, Cautela J, Alexandre J. Late cardiac adverse events in patients with cancer treated with immune checkpoint inhibitors. J Immunother Cancer. 2020 Jan;8(1):e000261. doi: 10.1136/jitc-2019-000261. PubMed 31988143 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2019 (actual). Primary completion is estimated for Mar 2030, 132 months after the start.

Of 793 non-industry observational studies under Heart Failure, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 99. This study's planned 132 months is above that.

Counting every sponsor, half of 975 studies reached it within 41 months; a quarter within 23 and three quarters within 89.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 13, 2019
First posted
Mar 20, 2019
StartActual
Mar 1, 2019
Primary completionEst.
Mar 1, 2030
CompletionEst.
Mar 1, 2030
Last update
Sep 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03882580
Lead sponsor
Groupe Hospitalier Pitie-Salpetriere
Responsible party
Joe Elie Salem (Assistant director, clinical investigation center Paris Est, Groupe Hospitalier Pitie-Salpetriere) — Principal investigator
First posted
Mar 20, 2019
Start date
Mar 1, 2019
Primary completion
Mar 1, 2030 (estimated)
Completion
Mar 1, 2030 (estimated)
Last update
Sep 11, 2026

Study contacts

Joe-Elie Salem, MD, PhD
Contact
joe-elie.salem@aphp.fr
(0)1 42 17 85 33 ext. +33
Stéphane Edehry, MD
Contact
stephane.edehry@aphp.fr
(0)1 49 28 24 59 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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