Pulmonary HypertensionNCT02892981
Dead Space Evaluation in Pulmonary Hypertension
A study testing cardiopulmonary exercise test,hypoxia and hypercapnia test in people with Pulmonary Hypertension, run by Centro Cardiologico Monzino.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- cardiopulmonary exercise test,hypoxia and hypercapnia test
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- relevant comorbidities
- usual contraindications for cardiopulmonary exercise test
- pulmonary hypertension associated to left heart and pulmonary disease, congenital heart diseases with evident cardiac shunts.
About this study
Official title: Dead Space Evaluation During Exercise in Patients With Pulmonary Hypertension
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.
- Conditions
- Pulmonary Hypertension
- Being tested
- cardiopulmonary exercise test,hypoxia and hypercapnia test
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiopulmonary exercise test,hypoxia and hypercapnia testOther
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
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary hypertension patients | Other | All Pulmonary hypertension patients enrolled in the study underwent a cardiopulmonary exercise test and hypoxia and hypercapnia tests Receives: Other: cardiopulmonary exercise test,hypoxia and hypercapnia test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Secondary outcomes (3)
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.
Measured: 1 week
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
Measured: 1 week
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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piergiuseppe Agostoni, Centro Cardiologico Monzino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892981
- Sponsor's protocol ID
- ccm257
- Status last verified
- Sep 2016
- First submitted
- 10 Jun 2016
- Last updated
- 8 Sep 2016
- Results posted
- No
Publications
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.
PubMed 29579597
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dead Space Evaluation During Exercise in Patients With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT02892981
- Acronym / sponsor ID
- ccm257
- Conditions
- Pulmonary Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary hypertension patients | Other | Other: cardiopulmonary exercise test,hypoxia and hypercapnia testAll Pulmonary hypertension patients enrolled in the study underwent a cardiopulmonary exercise test and hypoxia and hypercapnia tests |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- relevant comorbidities
- usual contraindications for cardiopulmonary exercise test
- pulmonary hypertension associated to left heart and pulmonary disease, congenital heart diseases with evident cardiac shunts.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiopulmonary exercise test,hypoxia and hypercapnia testclass 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 | Other | Pulmonary hypertension patients |
Primary outcome
dead space ventilation (measured in L/min)
Time frame: 1 week
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.
3 secondary outcomes
peripheral response to hypoxia (measured in L/min/O2)
Time frame: 1 week
peripheral response to hypercapnia (measured in L/min/mmHg)
Time frame: 1 week
central hypercapnic chemosensitivity (measured in L/min/mmHg)
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
- Derived from this study: PubMed 29579597Farina 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing cardiopulmonary exercise test,hypoxia and hypercapnia test in people with Pulmonary Hypertension, run by Centro Cardiologico Monzino.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dead space ventilation (measured in L/min) (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02892981, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2016.