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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

Tracking Information
First Submitted Date  ICMJE December 20, 2018
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date January 18, 2019
Estimated Study Start Date  ICMJE January 14, 2019
Estimated Primary Completion Date July 14, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
Prevalence of the hyperventilation syndrome [ Time Frame: 18 months ]
Prevalence of the hyperventilation syndrome in a population with pulmonary arterial hypertension
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • anxiety-depression questionary score [ Time Frame: 18 months ]
    results of anxiety-depression questionary
  • dyspnea score [ Time Frame: 18 months ]
    results of dyspnea questionary
  • quality of life score [ Time Frame: 18 months ]
    results of quality of life questionary
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevalence of the Hyperventilation Syndrome in Pulmonary Arterial Hypertension
Official Title  ICMJE Prevalence of the Hyperventilation Syndrome in Pulmonary Arterial Hypertension
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Pulmonary Arterial Hypertension
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Diagnostic Test: Hyperventilation test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 17, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 14, 2021
Estimated Primary Completion Date July 14, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Etienne-Marie JUTANT, CCA 01 45 21 78 91 etiennemarie.jutant@aphp.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03810443
Other Study ID Numbers  ICMJE APHP180352
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Etienne-Marie JUTANT, CCA APHP
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP