search
Back to results

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

Primary Purpose

Pulmonary Arterial Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hyperventilation test
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Arterial Hypertension focused on measuring Hyperventilation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Bicêtre - Pneumology department

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pulmonary arterial hypertension

Arm Description

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.

Outcomes

Primary Outcome Measures

Prevalence of the hyperventilation syndrome
Prevalence of the hyperventilation syndrome in a population with pulmonary arterial hypertension

Secondary Outcome Measures

anxiety-depression questionary score
results of anxiety-depression questionary
dyspnea score
results of dyspnea questionary
quality of life score
results of quality of life questionary

Full Information

First Posted
December 20, 2018
Last Updated
January 17, 2019
Sponsor
Assistance Publique - Hôpitaux de Paris
search

1. Study Identification

Unique Protocol Identification Number
NCT03810443
Brief Title
Prevalence of the Hyperventilation Syndrome in Pulmonary Arterial Hypertension
Acronym
HYPER2
Official Title
Prevalence of the Hyperventilation Syndrome in Pulmonary Arterial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 14, 2019 (Anticipated)
Primary Completion Date
July 14, 2021 (Anticipated)
Study Completion Date
July 14, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
Hyperventilation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pulmonary arterial hypertension
Arm Type
Experimental
Arm Description
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 Type
Diagnostic Test
Intervention Name(s)
Hyperventilation test
Other Intervention Name(s)
Questionnaire of Nijmegen, Questionnaire of Dyspnea, Questionnaire of quality of life, Questionnaire of screening for psychological disorders
Intervention Description
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.
Primary Outcome Measure Information:
Title
Prevalence of the hyperventilation syndrome
Description
Prevalence of the hyperventilation syndrome in a population with pulmonary arterial hypertension
Time Frame
18 months
Secondary Outcome Measure Information:
Title
anxiety-depression questionary score
Description
results of anxiety-depression questionary
Time Frame
18 months
Title
dyspnea score
Description
results of dyspnea questionary
Time Frame
18 months
Title
quality of life score
Description
results of quality of life questionary
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Etienne-Marie JUTANT, CCA
Phone
01 45 21 78 91
Email
etiennemarie.jutant@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Etienne-Marie JUTANT, CCA
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Bicêtre - Pneumology department
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94270
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Etienne-Marie JUTANT, CCA
Phone
01 45 21 78 91
Email
etiennemarie.jutant@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prevalence of the Hyperventilation Syndrome in Pulmonary Arterial Hypertension

We'll reach out to this number within 24 hrs