Funnel ChestHeartSoarNCT03770390
Cardiorespiratory Assessment and Quality of Life After Surgical Correction of Congenital Wall Malformations
A study testing Surgical correction of pectus excavatum in people with Funnel Chest, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The main objective of this study is to characterize the cardiorespiratory functional gain in patients with pectus excavatum following corrective surgery. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Funnel Chest
- What is being tested?
- Surgical correction of pectus excavatum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 16 Dec 2018to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Arnaud de Villeneuve - CHU de Montpellier
Montpellier, 34295
About this study
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
- Conditions
- Funnel Chest
- Being tested
- Surgical correction of pectus excavatum
- Medical subject headings
- Funnel Chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical correction of pectus excavatumProcedure or surgery
Surgical correction of pectus excavatum
| Study group | Role | What they receive |
|---|---|---|
| The study population | Other | 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 Receives: Procedure: Surgical correction of pectus excavatum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in: Oxygen pulse (mL O2 / heart beat)
Recorded during incremental exercise testing.
Measured: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Secondary outcomes (33)
Change in: Body mass index (kg/m^2)
Measured: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: The presence/absence of dyspnea during exercise
Measured: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: The presence/absence of palpitations
Measured: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: The presence/absence of psychosocial impact
Measured: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: VO2MAX (ml/kg/min)
Maximum oxygen consumption during incremental exercise testing.
Measured: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: VO2MAX (% predicted)
Maximum oxygen consumption during incremental exercise testing.
Measured: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: Maximum heart rate (bpm)
Maximum heart rate during incremental exercise testing.
Measured: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: Presence/absence of an anomaly in oxygen pulse
Presence/absence of an anomaly in oxygen pulse during incremental exercise testing.
Measured: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: Ventilatory threshold (% of VO2MAX)
The ventilatory threshold during incremental exercise testing.
Measured: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: Breathing Reserve (% of maximum voluntary ventilation)
The breathing reserved during incremental exercise testing.
Measured: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: Forced expiratory volume in 1 second (liters)
Measured: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: Forced expiratory volume in 1 second (% predicted)
Measured: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: Forced vital capacity (liters)
Measured: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: Forced vital capacity (% predicted)
Measured: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: Forced expiratory volume in 1 second (litres) / forced vital capacity (litres)
Measured: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: Residual volume (liters)
Measured: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: Residual volume (% predicted)
Measured: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: Total lung capacity (liters)
Measured: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: Total lung capacity (% predicted)
Measured: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: Residual volume / Total lung capacity (liters/liters)
Measured: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: Functional residual capacity (liters)
Measured: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: Functional residual capacity (% predicted)
Measured: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
The SF36 questionnaire
This is a general health related quality of life questionnaire.
Measured: post-op (expected maximum of 4 years)
The Body Esteem Scale
This questionnaire treats body esteem.
Measured: post-op (expected maximum of 4 years)
The Rosenberg Self Esteem Scale
This questionnaire treats self esteem.
Measured: post-op (expected maximum of 4 years)
Complications
Measured: per-op up to expected maximum of 4 years
Blood pressure (average, mmHg)
Per-operative hemodynamic measures
Measured: during surgery (day 0)
Pulse
Per-operative hemodynamic measures
Measured: during surgery (day 0)
Oxygen saturation (SpO2, %)
Per-operative hemodynamic measures
Measured: during surgery (day 0)
Cardiac index (liters/min/m^2)
Per-operative hemodynamic measures
Measured: during surgery (day 0)
Variation in ejection volume (%)
Per-operative hemodynamic measures
Measured: during surgery (day 0)
Indexed systolic ejection volume (ml/beat/m2)
Per-operative hemodynamic measures
Measured: during surgery (day 0)
Cumulative dose of vasopressors
Per-operative hemodynamic measures
Measured: during surgery (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start16 Dec 2018
- Primary completion31 Dec 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Funnel ChestStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This single group study documents changes before and after surgical correction of pectus excavatum.
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurence Solovei, MD, Principal investigator, University Hospitals of Montpellier, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770390
- Sponsor's protocol ID
- RECHMPL18_0184
- Other IDs
- 2018-A01574-51
- Acronym
- HeartSoar
- Status last verified
- Sep 2025
- First submitted
- 4 Dec 2018
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiorespiratory Assessment and Quality of Life After Surgical Correction of Congenital Wall Malformations
- ClinicalTrials.gov ID
- NCT03770390
- Acronym / sponsor ID
- HeartSoar / RECHMPL18_0184
- Conditions
- Funnel Chest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 16 Dec 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 10 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to characterize the cardiorespiratory functional gain in patients with pectus excavatum following corrective surgery.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This single group study documents changes before and after surgical correction of pectus excavatum.
| Arm | Type | Receives |
|---|---|---|
| The study population | Other | Procedure: Surgical correction of pectus excavatumPatients 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 |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical correction of pectus excavatumSurgical correction of pectus excavatum | Procedure or surgery | The study population |
Primary outcome
Change in: Oxygen pulse (mL O2 / heart beat)
Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Recorded during incremental exercise testing.
33 secondary outcomes
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))
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))
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))
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))
Change in: VO2MAX (ml/kg/min)
Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: VO2MAX (% predicted)
Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: Maximum heart rate (bpm)
Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: Presence/absence of an anomaly in oxygen pulse
Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: Ventilatory threshold (% of VO2MAX)
Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: Breathing Reserve (% of maximum voluntary ventilation)
Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
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))
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))
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))
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))
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))
Change in: Residual volume (liters)
Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: Residual volume (% predicted)
Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
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))
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))
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))
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))
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))
The SF36 questionnaire
Time frame: post-op (expected maximum of 4 years)
The Body Esteem Scale
Time frame: post-op (expected maximum of 4 years)
The Rosenberg Self Esteem Scale
Time frame: post-op (expected maximum of 4 years)
Complications
Time frame: per-op up to expected maximum of 4 years
Blood pressure (average, mmHg)
Time frame: during surgery (day 0)
Pulse
Time frame: during surgery (day 0)
Oxygen saturation (SpO2, %)
Time frame: during surgery (day 0)
Cardiac index (liters/min/m^2)
Time frame: during surgery (day 0)
Variation in ejection volume (%)
Time frame: during surgery (day 0)
Indexed systolic ejection volume (ml/beat/m2)
Time frame: during surgery (day 0)
Cumulative dose of vasopressors
Time frame: during surgery (day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Derived from this study: PubMed 37321811Suehs 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.
- Individual participant dataSharing planned: Undecided
Related trials for Funnel Chest
RecruitingObservational study
Biopsychosocial Risk Influences on the Development and Generation of Early-Onset Chronic Pain
Juvenile Idiopathic Arthritis (JIA), Fibromyalgia
Active, not recruiting
Comprehensive Study of Post-surgical Pain After Pectus or Spine Surgery
Pain, Postoperative, Excavatum, Pectus
Active, not recruitingObservational study
Postoperative and Chronic Pain Genetic Spine and Pectus Surgery Study
Scoliosis, Kyphosis
Recruiting
ES Catheter vs Cryoablation After Pectus Surgery
Pectus Excavatum
Active, not recruiting
Pectus Excavatum Camouflage (IT)
Pectus Excavatum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence Solovei, MD principal investigator
University Hospitals of Montpellier, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical correction of pectus excavatum in people with Funnel Chest, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in: Oxygen pulse (mL O2 / heart beat) (time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03770390, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.