Screening for Sleep Hypoxemia in Pulmonary Arterial Hypertension (Sommeil_HTAP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01371669
First received: December 13, 2010
Last updated: March 27, 2013
Last verified: March 2013
  Purpose

In the investigators study, and regarding results of small cohorts in the literature, the investigators hypothesize that hypoxemia is frequent in IPAH and CPEPH. The investigators will explore these patients with a one night polysomnography and transcutaneous capnography, searching for hypoxemia and hypercapnia and by determining its physiopathologic mechanisms.


Condition
Sleep Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study Searching for Hypoxemic Sleep Breathing Disorders in a Cohort of Patients With Idiopathic Pulmonary Arterial Hypertension (IPAH) and Chronic Post-embolic Pulmonary Hypertension (CPEPH)

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • hypoxemia during the night [ Time Frame: at the inclusion ] [ Designated as safety issue: No ]
    prevalence of nocturnal hypoxemia in IPAH and CPEPH


Secondary Outcome Measures:
  • Predictors: physical, functional and hemodynamical data [ Time Frame: at the inclusion ] [ Designated as safety issue: No ]
    Predictive factors of sleep hypoxemia in IPAH and CPEPH

  • Physiopathologic mechanisms: causes of nocturnal hypoxemia: hypoventilation, sleep disordered breathing, shunting, V/Q mismatch [ Time Frame: at the inclusion ] [ Designated as safety issue: No ]
    Physiopathologic mechanisms of sleep hypoxemia in IPAH and CPEPH


Enrollment: 50
Study Start Date: June 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
IPAH or CPEPH
Idiopathic pulmonary arterial hypertension (IPAH) or pulmonary hypertension associated with chronic post-embolic pulmonary hypertension (CPEPH)

Detailed Description:

Pulmonary hypertension (PH) is a rare and severe disease of young adults, characterized by a progressive increase in pulmonary vascular resistances leading to cardiac failure and death. Patients with PH are categorized in two major groups: primary PH (PPH) wich is idiopathic, and secondary PH associated with many conditions such as chronic pulmonary embolic diseases (CPED).Increase in vascular resistance in PH is secondary to vasoconstriction and to a proliferative remodeling process of the arterial wall leading to obliteration of the small arterioles. On the other hand, hypoxemia is known to cause similar changes in vascular architecture. Also, some small cohorts study in the literature mentioned an increase of sleep hypoxemia prevalence accounting for almost 70% of cases. The mechanisms of this hypoxemia are completely unknown.Our study is observational, prospective and transversal, searching for hypoxemic respiratory sleep disorders (HRSD) in PPH and in CPEPH. Included patients will have one night polysomnography (CIDELEC) with a continuous measurement of transcutaneous PCO2.The major objectives are to determine the prevalence of HRSD, their physiopathologic mechanisms and their possible causal factors according to PH history, clinical findings and hemodynamic severity.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with IPAH or CPEPH hospitalized in our pulmonary department for a standard follow-up. They have to be in a stable condition, as defined by the New York Heart Association classes for dyspnea and the six minutes walking test. Furthermore, no changes in medical therapy could have been made during the last three months.

Criteria

Inclusion Criteria:

  • Patient aged 18 to 75 years
  • Patient with IPAH ot CPEPH stable for at least 3 months. Stability is defined by the New York Heart Association classes for dyspnea and the six minutes walking test (6MWT). Furthermore, no changes in medical therapy had occured during the last three months.
  • Patients who signed informed consent

Exclusion Criteria:

  • Patients with secondary PH associated with other pathologies outside CPEPH ( sclerodermia, systemic lupus erythematous, portal hypertension, chronic HIV infection...)
  • Patients who had a functional and/or a hemodynamic degradation during the last 3 months or a change in pulmonary hypertension treatment
  • Patients with obstructive or restrictive ventilatory disorder with a Ventricular Ejection Fraction <60% predicted
  • Women without effective contraception
  • Patients with a Body Mass Index above 35 kg/m2
  • Patient not affiliated to a social security scheme
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01371669

Locations
France
Assistance Publique- Hôpitaux de Paris: Antoine Beclere Hospital
Clamart, France, 92141
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Gabriel ROISMAN, MD Assistance Publique - Hopitaux de Paris, Hôpital Antoine Beclere
  More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01371669     History of Changes
Other Study ID Numbers: P090206
Study First Received: December 13, 2010
Last Updated: March 27, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Pulmonary arterial hypertension
Chronic post embolic disease
Sleep hypoxemia
polysomnography
sleep apnea
periodic respiration

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Sleep Disorders
Parasomnias
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014