Exercise Oxygen Kinetic and Cardiac Output in Hypertrophic Cardiomyopathy

Hypertrophic Cardiomyopathy Clinical Trial

Official title:

Exercise Oxygen Kinetic and Cardiac Output in Hypertrophic Cardiomyopathy: a Multicenter Prospective Cardiopulmonary Exercise Testing Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05754489
• Other study ID #: CCM 1750
• Status: Recruiting
• Start date: April 20, 2022
• Est. completion date: April 2024

Study information

• Verified date: February 2023
• Source: Centro Cardiologico Monzino
• Contact: Piergiuseppe Agostoni, Prof.
• Phone: +39 0258002772
• Email: piergiuseppe.agostoni[@]ccfm.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Fatigue and dyspnea that reduce exercise performance are common symptoms in patients with hypertrophic cardiomyopathy. Since the cause of this functional limitation has not yet been described, this study aims to evaluate the cardiopulmonary parameters measured at cardiopulmonary exercise test in combination with those obtained by non-invasive measurement of cardiac output by impedance (Physioflow) and echocardiography. These results will help to better define the mechanisms underlying limitation in these patients, also in relation to the degree of LVOT obstruction.

The aim of the present study is to assess the cardiopulmonary response to exercise in patients with hypertrophic cardiomyopathy, based on the degree of LVOT obstruction, by adding non-invasive measurement of cardiac output by Physioflow and echocardiographic parameters to the cardiopulmonary exercise test parameters associated with stroke volume and cardiac output (ie. VO2/WR, O2pulse) Consecutive patients with a previous diagnosis of hypertrophic cardiomyopathy on optimised medical therapy will be enrolled to perform a cardiopulmonary exercise test with simultaneous measurement of cardiac output and an exercise echocardiogram for clinical routine.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• hypertrophic cardiomyopathy diagnosis

Exclusion Criteria:

• use of long-term oxygen therapy;

• presence of comorbidities affecting the ability to perform cardiopulmonary exercise test or interfering with exercise performance;

• concomitant at least moderate chronic obstructive pulmonary disease

Related Conditions & MeSH terms

• Cardiac Output Measurement
• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Cardiopulmonary Exercise Test
• Hypertrophic Cardiomyopathy
• Hypertrophy

Locations

Country	Name	City	State
Italy	Centro Cardiologico Monzino, Irccs	Milano
Italy	Azienda Ospedaliera Sant'Andrea	Rome
Italy	Azienda Sanitaria Universitaria Giuliano Isontina [ASUGI]	Trieste

Sponsors (3)

Lead Sponsor	Collaborator
Centro Cardiologico Monzino	Azienda Ospedaliera "Sant'Andrea", Azienda Sanitaria Universitaria Giuliano Isontina [ASUGI], Università di Trieste, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac output measurement	Evaluate cardiopulmonary exercise test parameters associated with stroke volume and cardiac output (ie. VO2/WR, O2pulse) with the addition of non-invasive measurement of cardiac output using Physioflow.	immediately after the evaluation
Secondary	Correlation with echocardiographic variables	Correlate functional and metabolic data with echocardiographic variables collected at rest and under stress.	immediately after the evaluation