Dead Space Evaluation in Pulmonary Hypertension
Dead Space Evaluation During Exercise in Patients With Pulmonary Hypertension
1 other identifier
interventional
18
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 10, 2016
CompletedFirst Posted
Study publicly available on registry
September 8, 2016
CompletedSeptember 8, 2016
September 1, 2016
1 year
June 10, 2016
September 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
peripheral response to hypoxia (measured in L/min/O2)
1 week
peripheral response to hypercapnia (measured in L/min/mmHg)
1 week
central hypercapnic chemosensitivity (measured in L/min/mmHg)
1 week
Study Arms (1)
Pulmonary hypertension patients
OTHERAll Pulmonary hypertension patients enrolled in the study underwent a cardiopulmonary exercise test and hypoxia and hypercapnia tests
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- relevant comorbidities
- usual contraindications for cardiopulmonary exercise test
- pulmonary hypertension associated to left heart and pulmonary disease, congenital heart diseases with evident cardiac shunts.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Farina S, Bruno N, Agalbato C, Contini M, Cassandro R, Elia D, Harari S, Agostoni P. Physiological insights of exercise hyperventilation in arterial and chronic thromboembolic pulmonary hypertension. Int J Cardiol. 2018 May 15;259:178-182. doi: 10.1016/j.ijcard.2017.11.023.
PMID: 29579597DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 10, 2016
First Posted
September 8, 2016
Study Start
January 1, 2015
Primary Completion
January 1, 2016
Study Completion
April 1, 2016
Last Updated
September 8, 2016
Record last verified: 2016-09