Clinical trial NCT05754489: Exercise Oxygen Kinetic and Cardiac Output in Hypertrophic Cardiomyopathy
Official title: Exercise Oxygen Kinetic and Cardiac Output in Hypertrophic Cardiomyopathy: a Multicenter Prospective Cardiopulmonary Exercise Testing Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiopulmonary Exercise Test
Hypertrophic Cardiomyopathy
Cardiac Output Measurement
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
Collaborators: name: Azienda Sanitaria Universitaria Giuliano Isontina [ASUGI], Università di Trieste, Italy
name: Azienda Ospedaliera "Sant'Andrea"
First posted: 2023-03-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with a previous diagnosis of hypertrophic cardiomyopathy in optimised medical therapy will be enrolled

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: cardiac output measurement
timeFrame: immediately after the evaluation
Secondary outcomes:
measure: Correlation with echocardiographic variables
timeFrame: immediately after the evaluation
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Centro Cardiologico Monzino, Irccs
city: Rome
country: Italy
facility: Azienda Ospedaliera Sant'Andrea
city: Trieste
country: Italy
facility: Azienda Sanitaria Universitaria Giuliano Isontina [ASUGI]
Study officials:
affiliation: Centro Cardiologico Monzino
name: Piergiuseppe Agostoni, Prof.
role: PRINCIPAL_INVESTIGATOR
References: