Screening for Sleep Hypoxemia in Pulmonary Arterial Hypertension

Sleep Disorders Clinical Trial

— Sommeil_HTAP  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01371669
• Other study ID #: P090206
• Status: Completed
• Phase: N/A
• First received: December 13, 2010
• Last updated: March 27, 2013
• Start date: June 2010
• Est. completion date: July 2011

Study information

• Verified date: March 2013
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension
• Parasomnias
• Sleep Disorders

Locations

Country	Name	City	State
France	Assistance Publique- Hôpitaux de Paris: Antoine Beclere Hospital	Clamart

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hypoxemia during the night	prevalence of nocturnal hypoxemia in IPAH and CPEPH	at the inclusion	No
Secondary	Predictors: physical, functional and hemodynamical data	Predictive factors of sleep hypoxemia in IPAH and CPEPH	at the inclusion	No
Secondary	Physiopathologic mechanisms: causes of nocturnal hypoxemia: hypoventilation, sleep disordered breathing, shunting, V/Q mismatch	Physiopathologic mechanisms of sleep hypoxemia in IPAH and CPEPH	at the inclusion	No