Dead Space Evaluation in Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

Dead Space Evaluation During Exercise in Patients With Pulmonary Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02892981
• Other study ID #: ccm257
• Status: Completed
• Phase: N/A
• First received: June 10, 2016
• Last updated: September 2, 2016
• Start date: January 2015
• Est. completion date: April 2016

Study information

• Verified date: September 2016
• Source: Centro Cardiologico Monzino
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Centro Cardiologico Monzino ethical committee
• Study type: Interventional

Clinical Trial Summary

Aim of the study is to evaluate the role of chemoreceptor activity and ventilation perfusion mismatch on the genesis of exercise induced hyperventilation in Pulmonary hypertension patients. So the investigators tested the chemoreceptor response at rest, both with hypoxic and hypercapnic stimuli, and the ventilatory response during exercise analyzing its two components, alveolar and dead space ventilation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age =18 and = 80 years

• ability to understand the research protocol and willing to sign the study informed consent

• diagnosis of pulmonary arterial hypertension belonging to Class I and IV

• stable haemodynamic status and optimized medical treatment since at least 2 months

• ability to perform maximal cardiopulmonary exercise test and pulmonary diffusing capacity for carbon monoxide evaluation

Exclusion Criteria:

• relevant comorbidities

• usual contraindications for cardiopulmonary exercise test

• pulmonary hypertension associated to left heart and pulmonary disease, congenital heart diseases with evident cardiac shunts.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Other:
• cardiopulmonary exercise test,hypoxia and hypercapnia test
class I and IV Pulmonary hypertension patients in stable haemodynamic status and optimized medical therapy underwent cardiopulmonary test and hypoxia and hypercapnia tests to evaluate the chemoreceptor sensitivity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centro Cardiologico Monzino

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dead space ventilation (measured in L/min)	Dead space ventilation is calculated through the equation: VT* [1- (863*VCO2)/(VE*PaCO2)], where VT = tidal volume, VCO2= CO2 output, VE= pulmonary ventilation,PaCO2 is the arterial partial pressure of CO2 and 863 is a constant.	1 week	No
Secondary	peripheral response to hypoxia (measured in L/min/O2)	the hypoxic test is based on the transient hypoxia (the patient inhales a mixture of nitrogen for 2-8 breaths, for 10-15 times); pulmonary ventilation (VE) and arterial oxygen saturation (O2 Saturation) by peripheral pulse oximetry is measured. The chemoreceptor sensitivity value is calculated as the slope of the trend line built on the two maximum consecutive VE and minimum O2 Saturation of each test.	1 week	No
Secondary	peripheral response to hypercapnia (measured in L/min/mmHg)	the peripheral response to hypercapnia is evaluated through the single-breath technique (the patient inhales a mixture of 13% CO2 in air for a single breath); pulmonary ventilation (VE) and end-expiratory CO2 fraction (FetCO2) are measured and then they will be used to calculate the peripheral chemoreceptor sensitivity.In fact, the sensitivity of the chemoreceptor is calculated using the following formula VEs-VEc / (FetCO2s-FetCO2c) * (PB-47), where s and c indicate the data collected after hypercapnic stimulus and those collected during control air breathing ,respectively; PB is the atmospheric pressure in mmHg	1 week	No
Secondary	central hypercapnic chemosensitivity (measured in L/min/mmHg)	the evaluation of the central response to hypercapnia is made through the re-breathing technique (the patient breathes through a reservoir containing 7% CO2 and 93% O2 for 4 minutes); pulmonary ventilation (VE) and partial pressure of end-tidal carbon dioxide (PetCO2) are evaluated. The slope of the curve describing the relationship between VE and PetCO2 identifies the central chemoreceptor sensitivity	1 week	No