Pulmonary HypertensionNCT05665218
Comparison of Different Cardiac Output Measurement Methods in Patients Undergoing Right Heart Catheterization
An observational study of Pulmonary Hypertension, run by UOSD Emodinamica Diagnostica e Interventistica at 1 site in Italy.
Trial summary
The objective of this observational study is to compare cardiac output evaluation by the Direct Fick method, Indirect Fick method and Thermodiluition in pulmonary hypertension (PH) patients undergoing right heart catheterization (RHC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- right heart catheterization
- How many people
- 1 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2022to 31 Dec 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients aged ≥18 years, referred for RHC for suspected PH, were included.
Who may be able to join
- Age ≥18 years
- Suspected pulmonary hypertension at clinical and echocardiographic evaluation
Who cannot join
- contraindication to Right Heart Catheterization (RHC)
- cardiac shunt
- inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
UOSD Emodinamica Diagnostica e Interventistica Ospedale SS Annunziata
Chieti, 66100
Livio Giuliani, MD PhD, 3473690091, lvgiuliani@gmail.com
Serena Rossi, MD, 3286721396, rossisere.rs@gmail.com
About this study
Official title: Cardiac Output Assessment in Pulmonary Hypertension Patients Undergoing Right Heart Catheterization
The objective of this observational study is to compare cardiac output evaluation by the Direct Fick method, Indirect Fick method and Thermodiluition in pulmonary hypertension (PH) patients undergoing right heart catheterization (RHC).
The main questions it aims to answer are:
- Are these methods interchangeable?
- Can possible discrepancies influence risk stratification and therapeutic management of PH patients? All consecutive patients aged ≥18 years, referred for RHC for suspected PH, will be included. Exclusion criteria will be contraindications to RHC, cardiac shunts and failure to obtain informed consent. Patients will undergo RHC by a Swan-Ganz catheter through the right internal jugular vein ultrasound-guided cannulation and cardiac output will be calculated using the three above-mentioned methods.
- Conditions
- Pulmonary Hypertension
- Being tested
- right heart catheterization
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
right heart catheterizationDiagnostic test
Right heart catheterization (RHC) is an invasive hemodynamic procedure that allows direct measurement of right-sided cardiac pressures, calculation of cardiac output and pulmonary vascular resistance. It is the gold standard for the diagnosis of pulmonary arterial hypertension. Right heart catheterization is commonly performed by accessing the internal jugular vein (echo-guided access). Swan Ganz catheter with a dedicated thermistor is used to perform RHC; it is advanced through the right heart chambers to measure right atrial, right ventricle, pulmonary artery and pulmonary arterial wedge pressures. Cardiac output is measured using Fick direct, Fick indirect and thermodilution methods.
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing right heart catheterization | Not described Receives: Diagnostic Test: right heart catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
differences in cardiac output values measured using three different methods (Direct Fick, Indirect Fick and Thermodiluition)
In all patients cardiac output will be measured using the three methods to evaluate if the values obtained significantly differ
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UOSD Emodinamica Diagnostica e Interventistica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Livio Giuliani, UOSD Emodinamica Diagnostica e Interventistica
- Investigators
- Livio Giuliani, MD PhD, Principal investigator, Interventional Cardiology Unit, SS Annunziata Hospital, Chieti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665218
- Sponsor's protocol ID
- CH2022-01
- Status last verified
- Dec 2022
- First submitted
- 8 Dec 2022
- Last updated
- 27 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Output Assessment in Pulmonary Hypertension Patients Undergoing Right Heart Catheterization
- ClinicalTrials.gov ID
- NCT05665218
- Acronym / sponsor ID
- CH2022-01
- Conditions
- Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- UOSD Emodinamica Diagnostica e InterventisticaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Dec 2022 (actual)
- 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.
The objective of this observational study is to compare cardiac output evaluation by the Direct Fick method, Indirect Fick method and Thermodiluition in pulmonary hypertension (PH) patients undergoing right heart catheterization (RHC).
The main questions it aims to answer are:
- Are these methods interchangeable?
- Can possible discrepancies influence risk stratification and therapeutic management of PH patients? All consecutive patients aged ≥18 years, referred for RHC for suspected PH, will be included. Exclusion criteria will be contraindications to RHC, cardiac shunts and failure to obtain informed consent. Patients will undergo RHC by a Swan-Ganz catheter through the right internal jugular vein ultrasound-guided cannulation and cardiac output will be calculated using the three above-mentioned methods.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergoing right heart catheterization | – | Diagnostic Test: right heart catheterization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients aged ≥18 years, referred for RHC for suspected PH, were included.
Key inclusion criteria (2 listed)
- Age ≥18 years
- Suspected pulmonary hypertension at clinical and echocardiographic evaluation
Key exclusion criteria (3 listed)
- contraindication to Right Heart Catheterization (RHC)
- cardiac shunt
- inability to provide informed consent
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 |
|---|---|---|
| right heart catheterizationRight heart catheterization (RHC) is an invasive hemodynamic procedure that allows direct measurement of right-sided cardiac pressures, calculation of cardiac output and pulmonary vascular resistance. It is the gold standard for the diagnosis of pulmonary arterial hypertension. Right heart catheterization is commonly performed by accessing the internal jugular vein (echo-guided access). Swan Ganz catheter with a dedicated thermistor is used to perform RHC; it is advanced through the right heart chambers to measure right atrial, right ventricle, pulmonary artery and pulmonary arterial wedge pressures. Cardiac output is measured using Fick direct, Fick indirect and thermodilution methods. | Diagnostic test | patients undergoing right heart catheterization |
Primary outcome
differences in cardiac output values measured using three different methods (Direct Fick, Indirect Fick and Thermodiluition)
Time frame: through study completion, an average of 1 year
In all patients cardiac output will be measured using the three methods to evaluate if the values obtained significantly differ
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
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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.
Livio Giuliani, MD PhD principal investigator
Interventional Cardiology Unit, SS Annunziata Hospital, Chieti
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by UOSD Emodinamica Diagnostica e Interventistica at 1 site in Italy.
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 2 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: status not confirmed, as of the sponsor's last update on 27 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Livio Giuliani, MD, PhD (+390871358978, lvgiuliani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
differences in cardiac output values measured using three different methods (Direct Fick, Indirect Fick and Thermodiluition) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2022.