NCT02892981

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

June 10, 2016

Last Update Submit

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

OTHER

All Pulmonary hypertension patients enrolled in the study underwent a cardiopulmonary exercise test and hypoxia and hypercapnia tests

Other: cardiopulmonary exercise test,hypoxia and hypercapnia test

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

Pulmonary hypertension patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

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