Pulmonary Arterial HypertensionHYPER2NCT03810443
Prevalence of the Hyperventilation Syndrome in Pulmonary Arterial Hypertension
A study testing Hyperventilation test in people with Pulmonary Arterial Hypertension, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Hyperventilation test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2019to 14 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Existence of another form of pulmonary hypertension
- Existence of vocal cord dysfunction
- Pregnancy
- Obesity> stage 2 (BMI 35 kg / m2)
- Age ≥ 75 years
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Bicêtre - Pneumology department
Le Kremlin-Bicêtre, 94270
Etienne-Marie JUTANT, CCA, 01 45 21 78 91, etiennemarie.jutant@aphp.fr
About this study
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).
Read the 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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Hyperventilation test
- Keywords
- Hyperventilation
- Medical subject headings
- Pulmonary Arterial Hypertension, Hyperventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperventilation testDiagnostic test
Also called Questionnaire of Nijmegen, Questionnaire of Dyspnea, Questionnaire of quality of life, Questionnaire of screening for psychological disorders
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Hyperventilation test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of the hyperventilation syndrome
Prevalence of the hyperventilation syndrome in a population with pulmonary arterial hypertension
Measured: 18 months
Secondary outcomes (3)
anxiety-depression questionary score
results of anxiety-depression questionary
Measured: 18 months
dyspnea score
results of dyspnea questionary
Measured: 18 months
quality of life score
results of quality of life questionary
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start14 Jan 2019 (estimated)
- Primary completion14 Jul 2021 (estimated)
- Study completion14 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne-Marie JUTANT, CCA, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810443
- Sponsor's protocol ID
- APHP180352
- Acronym
- HYPER2
- Status last verified
- Dec 2018
- First submitted
- 20 Dec 2018
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of the Hyperventilation Syndrome in Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT03810443
- Acronym / sponsor ID
- HYPER2 / APHP180352
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Hyperventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 14 Jan 2019 (estimated)
- Primary completion
- 14 Jul 2021 (estimated)
- Study completion
- 14 Jul 2021 (estimated)
- First posted
- 18 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pulmonary arterial hypertension | Experimental | Diagnostic Test: Hyperventilation testThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Existence of another form of pulmonary hypertension
- Existence of vocal cord dysfunction
- Pregnancy
- Obesity> stage 2 (BMI 35 kg / m2)
- Age ≥ 75 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperventilation testAlso: Questionnaire of Nijmegen, Questionnaire of Dyspnea, Questionnaire of quality of life, Questionnaire of screening for psychological disordersThe 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 | pulmonary arterial hypertension |
Primary outcome
Prevalence of the hyperventilation syndrome
Time frame: 18 months
Prevalence of the hyperventilation syndrome in a population with pulmonary arterial hypertension
3 secondary outcomes
anxiety-depression questionary score
Time frame: 18 months
dyspnea score
Time frame: 18 months
quality of life score
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etienne-Marie JUTANT, CCA principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperventilation test in people with Pulmonary Arterial Hypertension, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Etienne-Marie JUTANT, CCA (01 45 21 78 91, etiennemarie.jutant@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of the hyperventilation syndrome (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2019.