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CompletedNCT03770390HeartSoarUpdated Sep 30, 2025

Cardiorespiratory Assessment and Quality of Life After Surgical Correction of Congenital Wall Malformations

An interventional study of Surgical correction of pectus excavatum in Funnel Chest, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2025-09-30.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Not applicable
Ages
14 Years and older
Sex
All
01

Study summary

The main objective of this study is to characterize the cardiorespiratory functional gain in patients with pectus excavatum following corrective surgery.

Read the detailed description

The secondary objectives are:

  • To measure the quality of life of patients operated on for pectus excavatum
  • Identify and describe post-operative complications
  • Follow-up on the body mass index changes post-surgery
  • Evaluate intraoperative hemodynamic parameters before and after the retrosternal bar is placed non-invasively
02

Conditions studied

  • Funnel Chest

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03

In context

Funnel Chest

79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.

This study's enrollment of 43 is close to the median of 40 across 46 interventional studies indexed under Funnel Chest.

Browse Funnel Chest studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.

Browse University Hospital, Montpellier studies →

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

04

Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

  • Patient with pectus excavatum
  • The patient received corrective surgery within four years of enrollment and is scheduled for a follow-up visit --OR-- the patient is scheduled for corrective surgery during the inclusion period
  • Collection of informed written consent (patient and legal guardian, if applicable)
  • Obligation of affiliation or beneficiary of a social security programme

Exclusion criteria

Exclusion Criteria:

  • Impossibility for the patient to participate in his/her next annual follow-up visit
  • Absence of exercise test data AND respiratory function test data performed during the preoperative check-up
  • Subject in exclusion period required by another protocol
  • Pregnant or lactating woman, patient unable to give consent, protected adult, vulnerable persons (according to French Health Code articles L.1121-6, L.1121-7, L.1211-8, L.1211-9)
  • Subject deprived of liberty by judicial or administrative decision
  • Participation of the subject in another interventional protocol
  • Failure to properly inform the patient (e.g. a language barrier)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • Other
    The study population

    Patients included in this study have pectus excavatum. The have either already undergone corrective surgery during the four years prior to the inclusion period, or are scheduled for surgery during the inclusion period. Intervention: Surgical correction of pectus excavatum

    Procedure: Surgical correction of pectus excavatum

Interventions

  • ProcedureSurgical correction of pectus excavatum

    Surgical correction of pectus excavatum

06

What researchers measure

Primary outcomes

  1. Change in: Oxygen pulse (mL O2 / heart beat)

    Recorded during incremental exercise testing.

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

Secondary outcomes

  1. Change in: Body mass index (kg/m^2)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  2. Change in: The presence/absence of dyspnea during exercise

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  3. Change in: The presence/absence of palpitations

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  4. Change in: The presence/absence of psychosocial impact

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  5. Change in: VO2MAX (ml/kg/min)

    Maximum oxygen consumption during incremental exercise testing.

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  6. Change in: VO2MAX (% predicted)

    Maximum oxygen consumption during incremental exercise testing.

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  7. Change in: Maximum heart rate (bpm)

    Maximum heart rate during incremental exercise testing.

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  8. Change in: Presence/absence of an anomaly in oxygen pulse

    Presence/absence of an anomaly in oxygen pulse during incremental exercise testing.

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  9. Change in: Ventilatory threshold (% of VO2MAX)

    The ventilatory threshold during incremental exercise testing.

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  10. Change in: Breathing Reserve (% of maximum voluntary ventilation)

    The breathing reserved during incremental exercise testing.

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  11. Change in: Forced expiratory volume in 1 second (liters)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  12. Change in: Forced expiratory volume in 1 second (% predicted)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  13. Change in: Forced vital capacity (liters)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  14. Change in: Forced vital capacity (% predicted)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  15. Change in: Forced expiratory volume in 1 second (litres) / forced vital capacity (litres)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  16. Change in: Residual volume (liters)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  17. Change in: Residual volume (% predicted)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  18. Change in: Total lung capacity (liters)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  19. Change in: Total lung capacity (% predicted)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  20. Change in: Residual volume / Total lung capacity (liters/liters)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  21. Change in: Functional residual capacity (liters)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  22. Change in: Functional residual capacity (% predicted)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  23. The SF36 questionnaire

    This is a general health related quality of life questionnaire.

    Time frame: post-op (expected maximum of 4 years)

  24. The Body Esteem Scale

    This questionnaire treats body esteem.

    Time frame: post-op (expected maximum of 4 years)

  25. The Rosenberg Self Esteem Scale

    This questionnaire treats self esteem.

    Time frame: post-op (expected maximum of 4 years)

  26. Complications

    Time frame: per-op up to expected maximum of 4 years

  27. Blood pressure (average, mmHg)

    Per-operative hemodynamic measures

    Time frame: during surgery (day 0)

  28. Pulse

    Per-operative hemodynamic measures

    Time frame: during surgery (day 0)

  29. Oxygen saturation (SpO2, %)

    Per-operative hemodynamic measures

    Time frame: during surgery (day 0)

  30. Cardiac index (liters/min/m^2)

    Per-operative hemodynamic measures

    Time frame: during surgery (day 0)

  31. Variation in ejection volume (%)

    Per-operative hemodynamic measures

    Time frame: during surgery (day 0)

  32. Indexed systolic ejection volume (ml/beat/m2)

    Per-operative hemodynamic measures

    Time frame: during surgery (day 0)

  33. Cumulative dose of vasopressors

    Per-operative hemodynamic measures

    Time frame: during surgery (day 0)

07

Study locations

1 site
  • Hôpital Arnaud de Villeneuve - CHU de Montpellier
    Montpellier, 34295, France
08

References and documents

Publications

  • Suehs CM, Molinari N, Bourdin A, Solovei L. Change in cardiorespiratory parameters following surgical correction of pectus excavatum: protocol for the historical-prospective HeartSoar cohort. BMJ Open. 2023 Jun 15;13(6):e070891. doi: 10.1136/bmjopen-2022-070891. PubMed 37321811 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03770390
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Dec 10, 2018
Start date
Dec 16, 2018
Primary completion
Dec 31, 2023
Completion
Dec 31, 2024
Last update
Sep 30, 2025

Study contacts

Laurence Solovei, MD
principal investigator · University Hospitals of Montpellier, France

Oversight

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

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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