HYPER2: Prevalence of the Hyperventilation Syndrome in Pulmonary Arterial Hypertension

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Unknown status
CT.gov ID
NCT03810443
Collaborator
(none)
50
1
1
30
1.7

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Hyperventilation test
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Prevalence of the Hyperventilation Syndrome in Pulmonary Arterial Hypertension
Anticipated Study Start Date :
Jan 14, 2019
Anticipated Primary Completion Date :
Jul 14, 2021
Anticipated Study Completion Date :
Jul 14, 2021

Arms and Interventions

Arm Intervention/Treatment
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
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.
Other Names:
  • Questionnaire of Nijmegen
  • Questionnaire of Dyspnea
  • Questionnaire of quality of life
  • Questionnaire of screening for psychological disorders
  • Outcome Measures

    Primary Outcome Measures

    1. Prevalence of the hyperventilation syndrome [18 months]

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

    Secondary Outcome Measures

    1. anxiety-depression questionary score [18 months]

      results of anxiety-depression questionary

    2. dyspnea score [18 months]

      results of dyspnea questionary

    3. quality of life score [18 months]

      results of quality of life questionary

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:
    • Existence of another form of pulmonary hypertension

    • Existence of vocal cord dysfunction

    • Pregnancy

    • Obesity> stage 2 (BMI 35 kg / m2)

    • Age ≥ 75 years

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hôpital Bicêtre - Pneumology department Le Kremlin-Bicêtre France 94270

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    • Principal Investigator: Etienne-Marie JUTANT, CCA, APHP

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT03810443
    Other Study ID Numbers:
    • APHP180352
    First Posted:
    Jan 18, 2019
    Last Update Posted:
    Jan 18, 2019
    Last Verified:
    Dec 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 18, 2019