ClinicalTrials.gg
Status unknownNCT03810443HYPER2Updated Jan 18, 2019

Prevalence of the Hyperventilation Syndrome in Pulmonary Arterial Hypertension

An interventional study of Hyperventilation test in Pulmonary Arterial Hypertension, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-01-18.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Dyspnea is a major symptom in pulmonary arterial hypertension and people with the same haemodynamic have generally different degree of dyspnea in pulmonary arterial hypertension. The hyperventilation syndrome is a frequent cause of dyspnea in general population and in respiratory diseases like asthma but has never been studied in pulmonary hypertension. The goal of this study is to measure the prevalence of pulmonary hypertension in a population of patients with controlled pulmonary arterial hypertension (PAH).

Read the detailed description

Hyperventilation syndrome has been described as a cause of dyspnea in the general population and in several chronic respiratory diseases such as asthma with 20 to 40% of asthmatics affected. However, Hyperventilation syndrome has never been sought in a population with PAH. Hyperventilation syndrome, although complex pathophysiology, may be simply corrected by a management of respiratory physiotherapy based on the control of respiration.

02

Conditions studied

  • Pulmonary Arterial Hypertension

Keywords

  • Hyperventilation
03

In context

Pulmonary Arterial Hypertension

699 studies on the registry are indexed under Pulmonary Arterial Hypertension; 140 are open to participants now.

This study's planned enrollment of 50 is above the median of 40 across 477 interventional studies indexed under Pulmonary Arterial Hypertension.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
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

  • Non smoker or tobacco stopped for minimum 2 years ans maximum 10 year-pack. - Idiopathic, heritable, related to drug or toxics, associated with controlled pulmonary hypertension. Diagnosis and treatment of pulmonary hypertension for more than 4 months.
  • Optimal control of pulmonary hypertension (no right heart failure symptom and NTproBNP \< 300ng/L or Brain Natriuretic Peptide(BNP) \< 50 ng/L and optimal hemodynamic results measured by a right heart catheterization in the last year: right atrial pressure \< 8 mmHg, cardiac index > 2,5 L/min/m2, veinous saturation in oxygen > 65%)
  • Informed and written consent
  • Non-affiliation to a social security

Exclusion criteria

Exclusion Criteria:

  • Existence of another form of pulmonary hypertension
  • Existence of vocal cord dysfunction
  • Pregnancy
  • Obesity> stage 2 ( 35 kg / m2)
  • Age ≥ 75 years
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    pulmonary arterial hypertension

    The elements of the research consist of the Nijmegen questionnaire response, two dyspnea questionnaires (Dyspnea 12, MDP), a quality of life questionnaire (SF36), a psychological disorder screening questionnaire (HAD) and a diagnostic test: the hyperventilation test.

    Diagnostic Test: Hyperventilation test

Interventions

  • Diagnostic testHyperventilation test

    The elements of the research consist of the Nijmegen questionnaire response, two dyspnea questionnaires (Dyspnea 12, MDP), a quality of life questionnaire (SF36), a psychological disorder screening questionnaire (HAD) and a diagnostic test: the hyperventilation test.

    Also known as: Questionnaire of Nijmegen, Questionnaire of Dyspnea, Questionnaire of quality of life, Questionnaire of screening for psychological disorders

06

What researchers measure

Primary outcomes

  1. Prevalence of the hyperventilation syndrome

    Prevalence of the hyperventilation syndrome in a population with pulmonary arterial hypertension

    Time frame: 18 months

Secondary outcomes

  1. anxiety-depression questionary score

    results of anxiety-depression questionary

    Time frame: 18 months

  2. dyspnea score

    results of dyspnea questionary

    Time frame: 18 months

  3. quality of life score

    results of quality of life questionary

    Time frame: 18 months

07

Study locations

1 site
  • Hôpital Bicêtre - Pneumology department
    Le Kremlin-Bicêtre, 94270, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03810443
Responsible party
Sponsor
First posted
Jan 18, 2019
Start date
Jan 14, 2019 (estimated)
Primary completion
Jul 14, 2021 (estimated)
Completion
Jul 14, 2021 (estimated)
Last update
Jan 18, 2019

Study contacts

Etienne-Marie JUTANT, CCA
Contact
etiennemarie.jutant@aphp.fr
01 45 21 78 91
Etienne-Marie JUTANT, CCA
principal investigator · APHP

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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