Prevalence of the Hyperventilation Syndrome in Pulmonary Arterial Hypertension (HYPER2)

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).

Study Overview

• Status: Unknown
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Diagnostic test: Hyperventilation test

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: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Etienne-Marie JUTANT, CCA; Phone Number: 01 45 21 78 91; Email: etiennemarie.jutant@aphp.fr

Study Locations

• France
  • Le Kremlin-Bicêtre, France, 94270
    • Hôpital Bicêtre - Pneumology department
    • Contact: Etienne-Marie JUTANT, CCA; Phone Number: 01 45 21 78 91; Email: etiennemarie.jutant@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of the hyperventilation syndrome	Prevalence of the hyperventilation syndrome in a population with pulmonary arterial hypertension	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anxiety-depression questionary score	results of anxiety-depression questionary	18 months
dyspnea score	results of dyspnea questionary	18 months
quality of life score	results of quality of life questionary	18 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Etienne-Marie JUTANT, CCA, APHP

Study record dates

Study Major Dates

• Study Start (Anticipated): January 14, 2019
• Primary Completion (Anticipated): July 14, 2021
• Study Completion (Anticipated): July 14, 2021

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (Actual): January 18, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2019
• Last Update Submitted That Met QC Criteria: January 17, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Hyperventilation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Signs and Symptoms, Respiratory; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hyperventilation
• Other Study ID Numbers: APHP180352

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No