NCT03810443

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2018

Completed
25 days until next milestone

Study Start

First participant enrolled

January 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2021

Completed
Last Updated

January 18, 2019

Status Verified

December 1, 2018

Enrollment Period

2.5 years

First QC Date

December 20, 2018

Last Update Submit

January 17, 2019

Conditions

Pulmonary Arterial Hypertension

Keywords

Hyperventilation

Outcome Measures

Primary Outcomes (1)

  • Prevalence of the hyperventilation syndrome

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

    18 months

Secondary Outcomes (3)

  • anxiety-depression questionary score

    18 months

  • dyspnea score

    18 months

  • quality of life score

    18 months

Study Arms (1)

pulmonary arterial hypertension

EXPERIMENTAL

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

Interventions

Hyperventilation testDIAGNOSTIC_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.

Also known as: Questionnaire of Nijmegen, Questionnaire of Dyspnea, Questionnaire of quality of life, Questionnaire of screening for psychological disorders
pulmonary arterial hypertension

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Existence of another form of pulmonary hypertension
  • Existence of vocal cord dysfunction
  • Pregnancy
  • Obesity\> stage 2 (BMI 35 kg / m2)
  • Age ≥ 75 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Bicêtre - Pneumology department

Le Kremlin-Bicêtre, 94270, France

Location

MeSH Terms

Conditions

Pulmonary Arterial HypertensionHyperventilation

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Etienne-Marie JUTANT, CCA

    APHP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Etienne-Marie JUTANT, CCA

CONTACT

01 45 21 78 91etiennemarie.jutant@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2018

First Posted

January 18, 2019

Study Start

January 14, 2019

Primary Completion

July 14, 2021

Study Completion

July 14, 2021

Last Updated

January 18, 2019

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)