Prevalence of the Hyperventilation Syndrome in Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension Clinical Trial

— HYPER2  

Official title:

Prevalence of the Hyperventilation Syndrome in Pulmonary Arterial Hypertension

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03810443
• Other study ID #: APHP180352
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 14, 2019
• Est. completion date: July 14, 2021

Study information

• Verified date: December 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Etienne-Marie JUTANT, CCA
• Phone: 01 45 21 78 91
• Email: etiennemarie.jutant[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 14, 2021
• Est. primary completion date: July 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Hyperventilation
• Pulmonary Arterial Hypertension

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Bicêtre - Pneumology department	Le Kremlin-Bicêtre

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of the hyperventilation syndrome	Prevalence of the hyperventilation syndrome in a population with pulmonary arterial hypertension	18 months
Secondary	anxiety-depression questionary score	results of anxiety-depression questionary	18 months
Secondary	dyspnea score	results of dyspnea questionary	18 months
Secondary	quality of life score	results of quality of life questionary	18 months