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Trial record 1 of 1 for:    NCT03810443
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Prevalence of the Hyperventilation Syndrome in Pulmonary Arterial Hypertension (HYPER2)

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ClinicalTrials.gov Identifier: NCT03810443
Recruitment Status : Not yet recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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
Pulmonary Arterial Hypertension Diagnostic Test: Hyperventilation test Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prevalence of the Hyperventilation Syndrome in Pulmonary Arterial Hypertension
Estimated Study Start Date : January 14, 2019
Estimated Primary Completion Date : July 14, 2021
Estimated Study Completion Date : July 14, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Prevalence of the hyperventilation syndrome [ Time Frame: 18 months ]
    Prevalence of the hyperventilation syndrome in a population with pulmonary arterial hypertension


Secondary Outcome Measures :
  1. anxiety-depression questionary score [ Time Frame: 18 months ]
    results of anxiety-depression questionary

  2. dyspnea score [ Time Frame: 18 months ]
    results of dyspnea questionary

  3. quality of life score [ Time Frame: 18 months ]
    results of quality of life questionary


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810443


Contacts
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Contact: Etienne-Marie JUTANT, CCA 01 45 21 78 91 etiennemarie.jutant@aphp.fr

Locations
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France
Hôpital Bicêtre - Pneumology department
Le Kremlin-Bicêtre, France, 94270
Contact: Etienne-Marie JUTANT, CCA    01 45 21 78 91    etiennemarie.jutant@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Etienne-Marie JUTANT, CCA APHP
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03810443    
Other Study ID Numbers: APHP180352
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Hyperventilation
Additional relevant MeSH terms:
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Familial Primary Pulmonary Hypertension
Hyperventilation
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
 Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms