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Precapillary Pulmonary Hypertension | Patients With Pulmonary Hypertension or Interstitial Lung Disease at Altitude - Effect of Oxygen on Breathing and Sleep

Precapillary Pulmonary Hypertension research study

What is the primary objective of this study?

The purpose of this study is to investigate the effect of travelling to moderate altitude and of nocturnal oxygen therapy during a stay at moderate altitude on breathing and sleep of patients with pulmonary hypertension or with interstitial lung disease.

Who is eligible to participate?

Inclusion Criteria: - Precapillary pulmonary hypertension, or interstitial lung disease. - New York Heart Association class 2-3. - Residence at low altitude (<800m). Exclusion Criteria: - Unstable or exacerbated condition - Very severe pulmonary hypertension or interstitial lung disease, New York Heart Association class 4 - requirement for oxygen therapy at low altitude residence - hypoventilation - more than mild or unstable cardiovascular disease - use of drugs that affect respiratory center drive - internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (>20 cigarettes per day), inability to perform 6 min walk test. - previous intolerance to moderate altitude (<2600m). - Exposure to altitudes >1500m for >2 days within the last 4 weeks before the study. - Pregnant or nursing patients

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Precapillary Pulmonary Hypertension

Interstitial Lung Disease

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:Moderate altitude sojournParticipants will travel from Zurich (490 m) to St. Moritz Salastrains (2048 m) and stay there for 2 days

Behavioral:Low altitude sojournLow altitude baseline evaluations will be performed during a stay at Zurich (490)

Drug:OxygenOxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m

Drug:Sham oxygen (room air)Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights at 490 m and 2048 m

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Moderate altitude sojournSojourn at moderate altitude (2048 m)

Low altitude sojournSojourn at low altitude (490 m, baseline)

OxygenOxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m

Sham oxygen (room air)Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights

Study Status

Recruiting

Start Date: May 2014

Completed Date: December 2019

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Mean nocturnal oxygen saturation measured by pulse oximetry

Secondary Outcome: Mean nocturnal oxygen saturation measured by pulse oximetry

Study sponsors, principal investigator, and references

Principal Investigator: Konrad E Bloch, MD

Lead Sponsor: University of Zurich

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02150616

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