Heart FailureIC-E-PPCNCT02414126
Evaluation of Breathing, Sleep and the Effects of Continuous Positive Airway Pressure During Wakefulness in Children With Heart Failure
A study testing Effect of CPAP on respiratory work and cardiac function indices during wakefulness and CPAP in people with Heart Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Adult patients with heart failure (HF) have an increased work of breathing and are at increased risk for obstructive and/or central apnea during sleep. Noninvasive continuous positive airway pressure (CPAP) has proved its efficacy in decreasing the work of breathing and improving sleep-disordered breathing in these… Read more about this study
- Who is it for?
- Ages 8 months to 17 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Effect of CPAP on respiratory work and cardiac function indices during wakefulness and CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jul 2015to 30 Jul 2017
- 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 8 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A child with HF and having:
- Dilated cardiomyopathy with an ejection fraction <45%
- Univentricular congenital heart disease
- Left ventricular valvulopathy
- Age 8 months to 17 years
- Signed informed consent by the owner (s) of parental authority and investigator
- Patient affiliated to a social security scheme or entitled (excluding MEAs)
- Comparison of results depending on the status T21 / T21 not.
Who cannot join
- HF with use of inotropic drugs during the last 30 days.
- Contra indication to CPAP or inability to maintain the airway or adequately remove phlegm, risk of aspiration of gastric contents, acute sinusitis or diagnosis of otitis media, epistaxis, hypotension.
- Associated pathology may be responsible alone an obstructive apnea (ENT or maxillofacial malformation pathology, abnormalities of the upper airway, obesity with BMI z-score> 2), a central apnea syndrome (Chiari malformation), or alveolar hypoventilation (neuromuscular disease, cystic fibrosis or bronchopulmonary dysplasia).
Trial locations and contacts
1 site in 1 country.
France1 site
Necker - Enfants Malades Hospital (Assistance Publique des Hopitaux de Paris)
Paris, 75015
About this study
Adult patients with heart failure (HF) have an increased work of breathing and are at increased risk for obstructive and/or central apnea during sleep. Noninvasive continuous positive airway pressure (CPAP) has proved its efficacy in decreasing the work of breathing and improving sleep-disordered breathing in these patients.
The aim of the study is to analyze the work of breathing and objective and subjective sleep quality in children with HF and to evaluate the ability of noninvasive CPAP to decrease the work of breathing and improve cardiac output during wakefulness.
Read the detailed description
The study starts with the measurement during wakefulness of
- the breathing pattern and work of breathing
- and cardiac function during 5 min after 10 min of stable and calm spontaneous breathing (SB) Then the same measurement are made during 5 min after 10 min of stable and calm breathing during non-invasive CPAP Then a third measurement is made of
- the breathing pattern and work of breathing
- and cardiac function during 5 min after 10 min a stable and calm SB
Polysomnography is then performed during the following night during SB in order to assess objective sleep quality.
Subjective sleep quality is assessed on the following morning in children > 6 years of age by validated sleep questionnaires.
- Conditions
- Heart Failure
- Being tested
- Effect of CPAP on respiratory work and cardiac function indices during wakefulness, CPAP
- Keywords
- Heart failure, child, work of breathing, cardiac function, sleep, polysomnography, CPAP
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of CPAP on respiratory work and cardiac function indices during wakefulnessOther
Comparison of three periods of 3 hours
- st period: Spontaneous breathing for 10 minutes
- nd period: CPAP for 10 minutes
- rd period: Spontaneous breathing for 10 minutes to check the return to baseline.
After each period, the following parameters will be recorded during 5 minutes:
- oesogastric pressures
- air flow
- gas exchange
- right and left cardiac function
Patients > 6 years old will assess their dyspnea on a visual analogue scale
Effect of CPAP on respiratory work and cardiac function indices during wakefulnessOther
Comparison of three periods of 3 hours
- st period: Spontaneous breathing for 10 minutes
- nd period: CPAP for 10 minutes
- rd period: Spontaneous breathing for 10 minutes to check the return to baseline.
After each period, the following parameters will be recorded during 5 minutes:
- oesogastric pressures
- air flow
- gas exchange
- right and left cardiac function
Patients > 6 years old will assess their dyspnea on a visual analogue scale
Effect of CPAP on respiratory work and cardiac function indices during wakefulnessOther
Comparison of three periods of 3 hours
- st period: Spontaneous breathing for 10 minutes
- nd period: CPAP for 10 minutes
- rd period: Spontaneous breathing for 10 minutes to check the return to baseline.
After each period, the following parameters will be recorded during 5 minutes:
- oesogastric pressures
- air flow
- gas exchange
- right and left cardiac function
Patients > 6 years old will assess their dyspnea on a visual analogue scale
CPAPDevice
| Study group | Role | What they receive |
|---|---|---|
| Children with dilated cardiomyopathy with an ejection fraction | Active comparator | Not described Receives: Other: Effect of CPAP on respiratory work and cardiac function indices during wakefulness; Device: CPAP |
| Children with univentricular congenital heart disease | Active comparator | Not described Receives: Other: Effect of CPAP on respiratory work and cardiac function indices during wakefulness; Device: CPAP |
| Children with left valvulopathy | Active comparator | Not described Receives: Other: Effect of CPAP on respiratory work and cardiac function indices during wakefulness; Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
oesophageal pressure during spontaneous breathing and during continuous positive airway pressure
Measured: up to 5 days
trans-diaphragmatic pressure during spontaneous breathing and during continuous positive airway pressure
Measured: up to 5 days
Secondary outcomes (3)
Ultrasound cardiac function indices during spontaneous breathing and during continuous positive airway pressure
Measured: up to 5 days
Polysomnography during spontaneous breathing
Measured: up to 5 days
sleep questionnaire
Measured: up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study start10 Jul 2015
- Primary completion30 Jul 2017
- Study completion30 Jul 2017
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 Heart FailureStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414126
- Sponsor's protocol ID
- 2014 A1907-40
- Acronym
- IC-E-PPC
- Status last verified
- Sep 2025
- First submitted
- 24 Feb 2015
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Amaddeo A, Khraiche D, Khirani S, Meot M, Jais JP, Bonnet D, Fauroux B. Continuous positive airway pressure improves work of breathing in pediatric chronic heart failure. Sleep Med. 2021 Jul;83:99-105. doi: 10.1016/j.sleep.2021.04.003. Epub 2021 Apr 19.
PubMed 33991896
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Breathing, Sleep and the Effects of Continuous Positive Airway Pressure During Wakefulness in Children With Heart Failure
- ClinicalTrials.gov ID
- NCT02414126
- Acronym / sponsor ID
- IC-E-PPC / 2014 A1907-40
- Conditions
- Heart Failure
- Keywords
- Heart failure, child, work of breathing, cardiac function, sleep, polysomnography, CPAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Philips Healthcare, URC-CIC Paris Descartes Necker Cochin
- Study start
- 10 Jul 2015 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 30 Jul 2017 (actual)
- First posted
- 10 Apr 2015 (estimated)
- 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.
Adult patients with heart failure (HF) have an increased work of breathing and are at increased risk for obstructive and/or central apnea during sleep. Noninvasive continuous positive airway pressure (CPAP) has proved its efficacy in decreasing the work of breathing and improving sleep-disordered breathing in these patients.
The aim of the study is to analyze the work of breathing and objective and subjective sleep quality in children with HF and to evaluate the ability of noninvasive CPAP to decrease the work of breathing and improve cardiac output during wakefulness.
Detailed description
The study starts with the measurement during wakefulness of
- the breathing pattern and work of breathing
- and cardiac function during 5 min after 10 min of stable and calm spontaneous breathing (SB) Then the same measurement are made during 5 min after 10 min of stable and calm breathing during non-invasive CPAP Then a third measurement is made of
- the breathing pattern and work of breathing
- and cardiac function during 5 min after 10 min a stable and calm SB
Polysomnography is then performed during the following night during SB in order to assess objective sleep quality.
Subjective sleep quality is assessed on the following morning in children > 6 years of age by validated sleep questionnaires.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children with dilated cardiomyopathy with an ejection fraction | Active comparator | Other: Effect of CPAP on respiratory work and cardiac function indices during wakefulness, Device: CPAP |
| Children with univentricular congenital heart disease | Active comparator | Other: Effect of CPAP on respiratory work and cardiac function indices during wakefulness, Device: CPAP |
| Children with left valvulopathy | Active comparator | Other: Effect of CPAP on respiratory work and cardiac function indices during wakefulness, Device: CPAP |
Who may qualify
- Ages
- 8 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- A child with HF and having:
- Dilated cardiomyopathy with an ejection fraction <45%
- Univentricular congenital heart disease
- Left ventricular valvulopathy
- Age 8 months to 17 years
Key exclusion criteria (3 listed)
- HF with use of inotropic drugs during the last 30 days.
- Contra indication to CPAP or inability to maintain the airway or adequately remove phlegm, risk of aspiration of gastric contents, acute sinusitis or diagnosis of otitis media, epistaxis, hypotension.
- Associated pathology may be responsible alone an obstructive apnea (ENT or maxillofacial malformation pathology, abnormalities of the upper airway, obesity with BMI z-score> 2), a central apnea syndrome (Chiari malformation), or alveolar hypoventilation (neuromuscular disease, cystic fibrosis or bronchopulmonary dysplasia).
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 |
|---|---|---|
| Effect of CPAP on respiratory work and cardiac function indices during wakefulnessComparison of three periods of 3 hours 1. st period: Spontaneous breathing for 10 minutes 2. nd period: CPAP for 10 minutes 3. rd period: Spontaneous breathing for 10 minutes to check the return to baseline. After each period, the following parameters will be recorded during 5 minutes: * oesogastric pressures * air flow * gas exchange * right and left cardiac function Patients > 6 years old will assess their dyspnea on a visual analogue scale | Other | Children with dilated cardiomyopathy with an ejection fraction |
| Effect of CPAP on respiratory work and cardiac function indices during wakefulnessComparison of three periods of 3 hours 1. st period: Spontaneous breathing for 10 minutes 2. nd period: CPAP for 10 minutes 3. rd period: Spontaneous breathing for 10 minutes to check the return to baseline. After each period, the following parameters will be recorded during 5 minutes: * oesogastric pressures * air flow * gas exchange * right and left cardiac function Patients > 6 years old will assess their dyspnea on a visual analogue scale | Other | Children with univentricular congenital heart disease |
| Effect of CPAP on respiratory work and cardiac function indices during wakefulnessComparison of three periods of 3 hours 1. st period: Spontaneous breathing for 10 minutes 2. nd period: CPAP for 10 minutes 3. rd period: Spontaneous breathing for 10 minutes to check the return to baseline. After each period, the following parameters will be recorded during 5 minutes: * oesogastric pressures * air flow * gas exchange * right and left cardiac function Patients > 6 years old will assess their dyspnea on a visual analogue scale | Other | Children with left valvulopathy |
| CPAP | Device | Children with dilated cardiomyopathy with an ejection fraction, Children with left valvulopathy, Children with univentricular congenital heart disease |
Primary outcome
oesophageal pressure during spontaneous breathing and during continuous positive airway pressure
Time frame: up to 5 days
trans-diaphragmatic pressure during spontaneous breathing and during continuous positive airway pressure
Time frame: up to 5 days
3 secondary outcomes
Ultrasound cardiac function indices during spontaneous breathing and during continuous positive airway pressure
Time frame: up to 5 days
Polysomnography during spontaneous breathing
Time frame: up to 5 days
sleep questionnaire
Time frame: up to 5 days
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 11 Sep 2025.
- Results publication: PubMed 33991896Amaddeo A, Khraiche D, Khirani S, Meot M, Jais JP, Bonnet D, Fauroux B. Continuous positive airway pressure improves work of breathing in pediatric chronic heart failure. Sleep Med. 2021 Jul;83:99-105. doi: 10.1016/j.sleep.2021.04.003. Epub 2021 Apr 19.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effect of CPAP on respiratory work and cardiac function indices during wakefulness and CPAP in people with Heart Failure, run by Assistance Publique - Hôpitaux de Paris 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 8 inclusion and 3 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 11 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?
oesophageal pressure during spontaneous breathing and during continuous positive airway pressure (time frame: up to 5 days). The study lists 2 primary outcomes in all. 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 NCT02414126, 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 11 Sep 2025.