Comparison of Different Cardiac Output Measurement Methods in Patients Undergoing Right Heart Catheterization

Pulmonary Hypertension Clinical Trial

Official title:

Cardiac Output Assessment in Pulmonary Hypertension Patients Undergoing Right Heart Catheterization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05665218
• Other study ID #: CH2022-01
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2022
• Source: UOSD Emodinamica Diagnostica e Interventistica
• Contact: Livio Giuliani, MD, PhD
• Phone: +390871358978
• Email: lvgiuliani[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years

• Suspected pulmonary hypertension at clinical and echocardiographic evaluation

Exclusion Criteria:

• contraindication to Right Heart Catheterization (RHC)

• cardiac shunt

• inability to provide informed consent

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Diagnostic Test:
• right heart catheterization
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.

Locations

Country	Name	City	State
Italy	UOSD Emodinamica Diagnostica e Interventistica Ospedale SS Annunziata	Chieti

Sponsors (1)

Lead Sponsor	Collaborator
UOSD Emodinamica Diagnostica e Interventistica

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	through study completion, an average of 1 year