NCT02414126

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 10, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

July 10, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2017

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

2.1 years

First QC Date

February 24, 2015

Last Update Submit

September 5, 2025

Conditions

Heart Failure

Keywords

Heart failurechildwork of breathingcardiac functionsleeppolysomnographyCPAP

Outcome Measures

Primary Outcomes (2)

  • oesophageal pressure during spontaneous breathing and during continuous positive airway pressure

    up to 5 days

  • trans-diaphragmatic pressure during spontaneous breathing and during continuous positive airway pressure

    up to 5 days

Secondary Outcomes (3)

  • Ultrasound cardiac function indices during spontaneous breathing and during continuous positive airway pressure

    up to 5 days

  • Polysomnography during spontaneous breathing

    up to 5 days

  • sleep questionnaire

    up to 5 days

Study Arms (3)

Children with dilated cardiomyopathy with an ejection fraction

ACTIVE COMPARATOR
Other: Effect of CPAP on respiratory work and cardiac function indices during wakefulnessDevice: CPAP

Children with univentricular congenital heart disease

ACTIVE COMPARATOR
Other: Effect of CPAP on respiratory work and cardiac function indices during wakefulnessDevice: CPAP

Children with left valvulopathy

ACTIVE COMPARATOR
Other: Effect of CPAP on respiratory work and cardiac function indices during wakefulnessDevice: CPAP

Interventions

Effect of CPAP on respiratory work and cardiac function indices during wakefulnessOTHER

Comparison 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

Children with dilated cardiomyopathy with an ejection fraction
CPAPDEVICE
Children with dilated cardiomyopathy with an ejection fractionChildren with left valvulopathyChildren with univentricular congenital heart disease

Eligibility Criteria

Age8 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necker - Enfants Malades Hospital (Assistance Publique des Hopitaux de Paris)

Paris, 75015, France

Location

Related Publications (1)

  • 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.

    PMID: 33991896BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2015

First Posted

April 10, 2015

Study Start

July 10, 2015

Primary Completion

July 30, 2017

Study Completion

July 30, 2017

Last Updated

September 11, 2025

Record last verified: 2025-09

Locations

FR(1)