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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03810443
Other study ID # APHP180352
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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