Precapillary Pulmonary HypertensionHRV&PHNCT07464184
Evolution of Hypoxic Burden and Sympathetic/Parasympathetic Balance in Patients With Pulmonary Hypertension
A study testing Standard Clinical and Functional Assessment and Overnight Polysomnography in people with Precapillary Pulmonary Hypertension and Pulmonary Arterial Hypertension, run by University Hospital, Rouen at 1 site in France.
Trial summary
Background and Rationale: Sleep-disordered breathing and nocturnal hypoxemia are highly prevalent in patients with precapillary pulmonary hypertension (PH), and current guidelines recommend systematic sleep assessment in this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Precapillary Pulmonary Hypertension, Pulmonary Arterial Hypertension, Sleep-disordered Breathing
- What is being tested?
- Standard Clinical and Functional Assessment and Overnight Polysomnography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2026to 1 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age
- With precapillary pulmonary hypertension confirmed by pulmonary artery catheterization
- With an indication for pulmonary artery vasodilator treatment
- Affiliation with a social security system
- Women of childbearing age using effective/highly effective contraception (see CTFG) (estrogen-progestogen or intrauterine device or tubal ligation) for 6 months and a negative urine pregnancy test at inclusion, for the duration of the study.
- Postmenopausal women: confirmed diagnosis (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit)
Show all 18Show fewer
- Individuals who have read and understood the information letter and signed the consent form
- Non-Inclusion Criteria:
- Treatment with non-invasive ventilation
- Eisenmenger syndrome
- Systemic scleroderma
- Neurodegenerative disease other than isolated peripheral neuropathies.
- Untreated and/or uncontrolled cardiac rhythm or conduction disorders, including permanent AF
- Untreated coronary artery disease or diagnosis of myocardial infarction within the last six months
- Pacemaker wearer
- Pregnant or breastfeeding women, or women who are not using reliable contraception
- Persons deprived of their liberty by administrative or judicial decision or persons under judicial protection/guardianship or curatorship
- History of psychological or sensory illness or abnormality that may prevent the subject from fully understanding the conditions required for participation in the protocol or prevent them from giving their informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marie-Anne Melone, Dr contact
France1 site
Chu Rouen
Rouen, 76031
Marie-Anne Melone, Dr, Marieanne.Melone@chu-rouen.fr
Marie-Anne Melone, Dr
About this study
Background and Rationale:
Sleep-disordered breathing and nocturnal hypoxemia are highly prevalent in patients with precapillary pulmonary hypertension (PH), and current guidelines recommend systematic sleep assessment in this population. In obstructive sleep apnea, nocturnal hypoxic burden-defined as the area under the SpO₂ desaturation curve associated with respiratory events (%.min/h)-has demonstrated strong prognostic value for cardiovascular morbidity and mortality. However, its role in precapillary PH has not yet been investigated. Evaluating hypoxic burden in this population may refine indications and therapeutic targets for nocturnal oxygen therapy.
Read more
In addition, pulmonary hypertension is characterized by autonomic nervous system (ANS) dysfunction, including increased sympathetic tone, reduced heart rate variability (HRV), and a higher incidence of cardiac arrhythmias, all associated with worse prognosis. The reduction in HRV is particularly deleterious when occurring during restorative slow-wave sleep (N3), a phase marked by predominant parasympathetic activity essential for cardiovascular recovery and homeostasis. A better understanding of the interaction between nocturnal hypoxemia and ANS modulation may provide new prognostic markers and potential therapeutic targets in PH.
Objectives:
- To describe the evolution of nocturnal hypoxic burden over time in patients with precapillary pulmonary hypertension (at baseline, 12 months, and 24 months).
- To describe the longitudinal evolution of HRV parameters (RMSSD, LF/HF ratio, HF) at baseline, 12 months, and 24 months.
- To evaluate cross-sectional correlations (at baseline, M12, and M24) between HRV parameters, hypoxic burden, oxygen desaturation, apnea-hypopnea index (AHI), and clinical status.
- To evaluate longitudinal correlations between changes in HRV parameters, hypoxic burden, desaturation, AHI, and clinical status between baseline and M12, and between baseline and M24.
- To assess the 2-year prognostic value of HRV parameters and hypoxic burden for adverse clinical outcomes.
Study Design and Population:
This is a prospective, single-center observational cohort study conducted at the Pulmonary Hypertension Referral Center of Rouen University Hospital. The cohort design allows longitudinal assessment of HRV, hypoxic burden, and clinical status, enabling both cross-sectional and longitudinal correlation analyses, as well as prognostic evaluation. A total of 60 adult patients (≥18 years) with precapillary pulmonary hypertension confirmed by right heart catheterization and requiring pulmonary arterial vasodilator therapy will be included.
Participants will undergo full overnight polysomnography (PSG) at:
- Baseline (inclusion)
- 12 months (M12)
- 24 months (M24) For incident cases, baseline PSG will be performed prior to initiation of vasodilator therapy. All patients will continue to receive standard-of-care management according to current European guidelines for pulmonary hypertension.
Descriptive analyses and cross-sectional correlations will pool repeated measures (excluding incident baseline values for generalization to prevalent cases). Intra-subject correlation will be accounted for using bootstrap methods. Longitudinal analyses will assess changes over time and prognostic associations. The prognostic value of HRV and hypoxic burden will be evaluated over a 2-year follow-up period. This study explores an original dimension of precapillary pulmonary hypertension pathophysiology by investigating the interaction between nocturnal oxygenation, autonomic dysfunction, and clinical evolution. Identification of hypoxic burden and HRV as prognostic markers may contribute to improved risk astratification and therapeutic optimization in this high-risk population.
- Conditions
- Precapillary Pulmonary Hypertension, Pulmonary Arterial Hypertension, Sleep-disordered Breathing, Nocturnal Hypoxemia, Autonomic Nervous System Dysfunction, Heart Rate Variability (HRV)
- Being tested
- Standard Clinical and Functional Assessment, Overnight Polysomnography
- Keywords
- Precapillary pulmonary hypertension, Pulmonary arterial hypertension, Hypoxic burden, Nocturnal hypoxia, Polysomnography, Sleep-disordered breathing, Heart rate variability (HRV), RMSSD, LF/HF ratio, High frequency, Autonomic nervous system, Sympathetic activation, Parasympathetic tone, Risk stratification, Prognostic markers, Right heart failure, Apnea-Hypopnea Index (AHI)
- Medical subject headings
- Pulmonary Arterial Hypertension, Sleep Apnea Syndromes, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Clinical and Functional AssessmentOther
Routine evaluation of pulmonary hypertension during scheduled hospitalizations at baseline, Month 12, and Month 24, including:
- Physical examination and NYHA functional class assessment
- NT-proBNP measurement
- Arterial blood gases
- 6-minute walk test
- Transthoracic echocardiography
- Pulmonary function testing For incident cases at diagnostic evaluation only: thoracic CT scan, ventilation/perfusion lung scintigraphy, and right heart catheterization.
All procedures are performed as part of standard clinical care.
Overnight PolysomnographyOther
Standard overnight in-hospital polysomnography performed at baseline, Month 12, and Month 24. The recording includes electrocardiogram (ECG), oxygen saturation (SpO₂), respiratory parameters, and sleep staging. Heart rate variability (HRV) is assessed using RMSSD, LF/HF ratio, and HF power derived from ECG during a continuous ≥30-minute NREM sleep period. Nocturnal hypoxic burden is calculated as the area under the SpO₂ desaturation curve associated with respiratory events divided by total sleep time (%.min/h).
| Study group | Role | What they receive |
|---|---|---|
| Precapillary Pulmonary Hypertension Cohort | Experimental | Participants are hospitalized for 5 days (4 nights) at baseline, Month 12 (M12), and Month 24 (M24) in the pulmonology department for routine clinical reassessment. During each hospitalization, patients undergo standard-of-care clinical evaluation including physical examination, NYHA functional class assessment, NT-proBNP measurement, arterial blood gas analysis, 6-minute walk test, transthoracic echocardiography, and pulmonary function testing. At baseline (incident cases only), additional diagnostic procedures may include thoracic CT scan, ventilation/perfusion lung scintigraphy, and right heart catheterization. An overnight polysomnography (PSG) is performed during each hospitalization (baseline, M12, M24). Heart rate variability (HRV) parameters and nocturnal hypoxic burden are derived from PSG recordings. No experimental therapeutic intervention is assigned. All patients receive guideline-based management according to current European recommendations for pulmonary hypertension Receives: Other: Standard Clinical and Functional Assessment; Other: Overnight Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxic Load
Assessed by the area under the SpO2 curve during desaturations associated with respiratory events divided by sleep time expressed as % min/h during polysomnographies
Measured: Baseline, after 12 months and after 24 months
Secondary outcomes (18)
Root mean square of successive differences (RMSSD)
Obtained by Labchart software from an electrocardiogram during a period of NREM (non-rapid eye movement) sleep lasting at least 30 minutes, the earliest after falling asleep as measured by polysomnography.
Measured: Baseline, after 12 months and after 24 months
Low frequency / high frequency (LF/HF)
Obtained by Labchart software from an electrocardiogram during a period of NREM (non-rapid eye movement) sleep, lasting at least 30 minutes, the earliest after falling asleep as measured by polysomnography.
Measured: Baseline, after 12 months and after 24 months
High frequency (HF)
Obtained by Labchart software from an electrocardiogram during a period of NREM (non-rapid eye movement) sleep, lasting at least 30 minutes, the earliest after falling asleep as measured by polysomnography.
Measured: Baseline, after 12 months and after 24 months
Cross-sectional correlation - HRV RMSSD
Obtained by Labchart software from an electrocardiogram during a period of NREM (non-rapid eye movement) sleep lasting at least 30 minutes, the earliest after falling asleep as measured by polysomnography.
Measured: Baseline, after 12 months and after 24 months
Cross-sectional correlation - HRV LF/HF
Obtained by Labchart software from an electrocardiogram during a period of NREM (non-rapid eye movement) sleep lasting at least 30 minutes, the earliest after falling asleep as measured by polysomnography.
Measured: Baseline, after 12 months and after 24 months
Cross-sectional correlation - HRV HF
Obtained by Labchart software from an electrocardiogram during a period of NREM (non-rapid eye movement) sleep lasting at least 30 minutes, the earliest after falling asleep as measured by polysomnography.
Measured: Baseline, after 12 months and after 24 months
Cross-sectional correlation - HRV Hypoxic load
Assessed by the area under the SpO2 curve during desaturations associated with respiratory events divided by sleep time expressed as %.min/h during polysomnography.
Measured: Baseline, after 12 months and after 24 months
Cross-sectional correaltion - HRV Desaturation
As a percentage of time spent with SpO2 < 90%
Measured: Baseline, after 12 months and after 24 months
Cross-sectional correlation - HRV Apnea-hypopnea index
In number per hour of sleep
Measured: Baseline, after 12 months and after 24 months
Cross-sectional correlation - HRV Pulmonary hypertension
Defined by the 4-strata risk assessment (low, intermediate low, and high risk) based on NYHA functional class, the 6-minute walk test, and NTproBNP
Measured: Baseline, after 12 months and after 24 months
Correlation of evolution - HRV RMSSD
Obtained by Labchart software from an electrocardiogram during a period of NREM (non-rapid eye movement) sleep lasting at least 30 minutes, the earliest after falling asleep as measured by polysomnography.
Measured: Baseline, after 12 months and after 24 months
Correlation of evolution - HRV LF/HF
Obtained by Labchart software from an electrocardiogram during a period of NREM (non-rapid eye movement) sleep lasting at least 30 minutes, the earliest after falling asleep as measured by polysomnography.
Measured: Baseline, after 12 months and after 24 months
Correlation of evolution - HRV HL
Obtained by Labchart software from an electrocardiogram during a period of NREM (non-rapid eye movement) sleep lasting at least 30 minutes, the earliest after falling asleep as measured by polysomnography.
Measured: Baseline, after 12 months and after 24 months
Correlation of evolution - HRV Hypoxic load
Assessed by the area under the SpO2 curve during desaturations associated with respiratory events divided by sleep time expressed as %.min/h during polysomnography.
Measured: Baseline, after 12 months and after 24 months
Correlation of evolution - HRV Desaturation
As a percentage of time spent with SpO2 < 90%
Measured: Baseline, after 12 months and after 24 months
Correlation of evolution - HRV Apnea-hypopnea index
In number per hour of sleep.
Measured: Baseline, after 12 months and after 24 months
Correlation of evolution - HRV Pulmonary hypertension
Defined by the 4-strata risk assessment (low, intermediate low, and high risk) based on NYHA functional class, the 6-minute walk test, and NTproBNP
Measured: Baseline, after 12 months and after 24 months
Analysis of the 2-year prognostic value of hypoxic load and HRV for an unfavorable prognosis defined by a composite event
Based on :
- The occurrence of right heart failure
- The introduction of additional vasodilator therapy
- The introduction of non-invasive ventilation therapy
- Death
- Lung or heart-lung transplantation.
Measured: After 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precapillary Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-center, longitudinal cohort study of adult patients with precapillary pulmonary hypertension confirmed by right heart catheterization. Participants undergo standardized overnight polysomnography (PSG) at baseline, 12 months, and 24 months as part of routine clinical follow-up. The study evaluates longitudinal changes in nocturnal hypoxic burden and heart rate variability parameters and their cross-sectional and longitudinal correlations with clinical status and 2-year prognosis. No experimental intervention is assigned. All patients receive standard-of-care management according to current European guidelines for pulmonary hypertension.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464184
- Sponsor's protocol ID
- 2023/0292/HP
- Other IDs
- 2025-A00017-42
- Acronym
- HRV&PH
- Status last verified
- Apr 2026
- First submitted
- 27 Feb 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Hypoxic Burden and Sympathetic/Parasympathetic Balance in Patients With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT07464184
- Acronym / sponsor ID
- HRV&PH / 2023/0292/HP
- Conditions
- Precapillary Pulmonary Hypertension, Pulmonary Arterial Hypertension, Sleep-disordered Breathing, Nocturnal Hypoxemia, Autonomic Nervous System Dysfunction, Heart Rate Variability (HRV)
- Keywords
- Precapillary pulmonary hypertension, Pulmonary arterial hypertension, Hypoxic burden, Nocturnal hypoxia, Polysomnography, Sleep-disordered breathing, Heart rate variability (HRV), RMSSD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 11 Mar 2026 (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.
Background and Rationale:
Sleep-disordered breathing and nocturnal hypoxemia are highly prevalent in patients with precapillary pulmonary hypertension (PH), and current guidelines recommend systematic sleep assessment in this population. In obstructive sleep apnea, nocturnal hypoxic burden-defined as the area under the SpO₂ desaturation curve associated with respiratory events (%.min/h)-has demonstrated strong prognostic value for cardiovascular morbidity and mortality. However, its role in precapillary PH has not yet been investigated. Evaluating hypoxic burden in this population may refine indications and therapeutic targets for nocturnal oxygen therapy.
In addition, pulmonary hypertension is characterized by autonomic nervous system (ANS) dysfunction, including increased sympathetic tone, reduced heart rate variability (HRV), and a higher incidence of cardiac arrhythmias, all associated with worse prognosis. The reduction in HRV is particularly deleterious when occurring during restorative slow-wave sleep (N3), a phase marked by predominant parasympathetic activity essential for cardiovascular recovery and homeostasis. A better understanding of the interaction between nocturnal hypoxemia and ANS modulation may provide new prognostic markers and potential therapeutic targets in PH.
Objectives:
- To describe the evolution of nocturnal hypoxic burden over time in patients with precapillary pulmonary hypertension (at baseline, 12 months, and 24 months).
- To describe the longitudinal evolution of HRV parameters (RMSSD, LF/HF ratio, HF) at baseline, 12 months, and 24 months.
- To evaluate cross-sectional correlations (at baseline, M12, and M24) between HRV parameters, hypoxic burden, oxygen desaturation, apnea-hypopnea index (AHI), and clinical status.
- To evaluate longitudinal correlations between changes in HRV parameters, hypoxic burden, desaturation, AHI, and clinical status between baseline and M12, and between baseline and M24.
- To assess the 2-year prognostic value of HRV parameters and hypoxic burden for adverse clinical outcomes.
Study Design and Population:
This is a prospective, single-center observational cohort study conducted at the Pulmonary Hypertension Referral Center of Rouen University Hospital. The cohort design allows longitudinal assessment of HRV, hypoxic burden, and clinical status, enabling both cross-sectional and longitudinal correlation analyses, as well as prognostic evaluation. A total of 60 adult patients (≥18 years) with precapillary pulmonary hypertension confirmed by right heart catheterization and requiring pulmonary arterial vasodilator therapy will be included.
Participants will undergo full overnight polysomnography (PSG) at:
- Baseline (inclusion)
- 12 months (M12)
- 24 months (M24) For incident cases, baseline PSG will be performed prior to initiation of vasodilator therapy. All patients will continue to receive standard-of-care management according to current European guidelines for pulmonary hypertension.
Descriptive analyses and cross-sectional correlations will pool repeated measures (excluding incident baseline values for generalization to prevalent cases). Intra-subject correlation will be accounted for using bootstrap methods. Longitudinal analyses will assess changes over time and prognostic associations. The prognostic value of HRV and hypoxic burden will be evaluated over a 2-year follow-up period. This study explores an original dimension of precapillary pulmonary hypertension pathophysiology by investigating the interaction between nocturnal oxygenation, autonomic dysfunction, and clinical evolution. Identification of hypoxic burden and HRV as prognostic markers may contribute to improved risk astratification and therapeutic optimization in this high-risk population.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-center, longitudinal cohort study of adult patients with precapillary pulmonary hypertension confirmed by right heart catheterization. Participants undergo standardized overnight polysomnography (PSG) at baseline, 12 months, and 24 months as part of routine clinical follow-up. The study evaluates longitudinal changes in nocturnal hypoxic burden and heart rate variability parameters and their cross-sectional and longitudinal correlations with clinical status and 2-year prognosis. No experimental intervention is assigned. All patients receive standard-of-care management according to current European guidelines for pulmonary hypertension.
| Arm | Type | Receives |
|---|---|---|
| Precapillary Pulmonary Hypertension Cohort | Experimental | Other: Standard Clinical and Functional Assessment, Other: Overnight PolysomnographyParticipants are hospitalized for 5 days (4 nights) at baseline, Month 12 (M12), and Month 24 (M24) in the pulmonology department for routine clinical reassessment. During each hospitalization, patients undergo standard-of-care clinical evaluation including physical examination, NYHA functional class assessment, NT-proBNP measurement, arterial blood gas analysis, 6-minute walk test, transthoracic echocardiography, and pulmonary function testing. At baseline (incident cases only), additional diagnostic procedures may include thoracic CT scan, ventilation/perfusion lung scintigraphy, and right heart catheterization. An overnight polysomnography (PSG) is performed during each hospitalization (baseline, M12, M24). Heart rate variability (HRV) parameters and nocturnal hypoxic burden are derived from PSG recordings. No experimental therapeutic intervention is assigned. All patients receive guideline-based management according to current European recommendations for pulmonary hypertension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients over 18 years of age
- With precapillary pulmonary hypertension confirmed by pulmonary artery catheterization
- With an indication for pulmonary artery vasodilator treatment
- Affiliation with a social security system
- Women of childbearing age using effective/highly effective contraception (see CTFG) (estrogen-progestogen or intrauterine device or tubal ligation) for 6 months and a negative urine pregnancy test at inclusion, for the duration of the study.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Standard Clinical and Functional AssessmentRoutine evaluation of pulmonary hypertension during scheduled hospitalizations at baseline, Month 12, and Month 24, including: * Physical examination and NYHA functional class assessment * NT-proBNP measurement * Arterial blood gases * 6-minute walk test * Transthoracic echocardiography * Pulmonary function testing For incident cases at diagnostic evaluation only: thoracic CT scan, ventilation/perfusion lung scintigraphy, and right heart catheterization. All procedures are performed as part of standard clinical care. | Other | Precapillary Pulmonary Hypertension Cohort |
| Overnight PolysomnographyStandard overnight in-hospital polysomnography performed at baseline, Month 12, and Month 24. The recording includes electrocardiogram (ECG), oxygen saturation (SpO₂), respiratory parameters, and sleep staging. Heart rate variability (HRV) is assessed using RMSSD, LF/HF ratio, and HF power derived from ECG during a continuous ≥30-minute NREM sleep period. Nocturnal hypoxic burden is calculated as the area under the SpO₂ desaturation curve associated with respiratory events divided by total sleep time (%.min/h). | Other | Precapillary Pulmonary Hypertension Cohort |
Primary outcome
Hypoxic Load
Time frame: Baseline, after 12 months and after 24 months
Assessed by the area under the SpO2 curve during desaturations associated with respiratory events divided by sleep time expressed as % min/h during polysomnographies
18 secondary outcomes
Root mean square of successive differences (RMSSD)
Time frame: Baseline, after 12 months and after 24 months
Low frequency / high frequency (LF/HF)
Time frame: Baseline, after 12 months and after 24 months
High frequency (HF)
Time frame: Baseline, after 12 months and after 24 months
Cross-sectional correlation - HRV RMSSD
Time frame: Baseline, after 12 months and after 24 months
Cross-sectional correlation - HRV LF/HF
Time frame: Baseline, after 12 months and after 24 months
Cross-sectional correlation - HRV HF
Time frame: Baseline, after 12 months and after 24 months
Cross-sectional correlation - HRV Hypoxic load
Time frame: Baseline, after 12 months and after 24 months
Cross-sectional correaltion - HRV Desaturation
Time frame: Baseline, after 12 months and after 24 months
Cross-sectional correlation - HRV Apnea-hypopnea index
Time frame: Baseline, after 12 months and after 24 months
Cross-sectional correlation - HRV Pulmonary hypertension
Time frame: Baseline, after 12 months and after 24 months
Correlation of evolution - HRV RMSSD
Time frame: Baseline, after 12 months and after 24 months
Correlation of evolution - HRV LF/HF
Time frame: Baseline, after 12 months and after 24 months
Correlation of evolution - HRV HL
Time frame: Baseline, after 12 months and after 24 months
Correlation of evolution - HRV Hypoxic load
Time frame: Baseline, after 12 months and after 24 months
Correlation of evolution - HRV Desaturation
Time frame: Baseline, after 12 months and after 24 months
Correlation of evolution - HRV Apnea-hypopnea index
Time frame: Baseline, after 12 months and after 24 months
Correlation of evolution - HRV Pulmonary hypertension
Time frame: Baseline, after 12 months and after 24 months
Analysis of the 2-year prognostic value of hypoxic load and HRV for an unfavorable prognosis defined by a composite event
Time frame: After 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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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.
Marie-Anne Melone, Dr contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Clinical and Functional Assessment and Overnight Polysomnography in people with Precapillary Pulmonary Hypertension and Pulmonary Arterial Hypertension, run by University Hospital, Rouen 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 18 inclusion and 0 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: opening soon, as of the sponsor's last update on 15 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DRCI (02 32 88 56 07, secretariat.DRC@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoxic Load (time frame: Baseline, after 12 months and after 24 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 15 Apr 2026.