Exercise Oxygen Kinetic and Cardiac Output in Hypertrophic Cardiomyopathy

NCT ID: NCT05754489

Last Updated: 2023-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-20

Study Completion Date

2024-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiopulmonary Exercise Test Hypertrophic Cardiomyopathy Cardiac Output Measurement

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Sanitaria Universitaria Giuliano Isontina [ASUGI], Università di Trieste, Italy

UNKNOWN

Sponsor Role collaborator

Azienda Ospedaliera "Sant'Andrea"

OTHER

Sponsor Role collaborator

Centro Cardiologico Monzino

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Piergiuseppe Agostoni, Prof.

Role: PRINCIPAL_INVESTIGATOR

Centro Cardiologico Monzino

Locations

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Centro Cardiologico Monzino, Irccs

Milan, , Italy

Site Status RECRUITING

Azienda Ospedaliera Sant'Andrea

Rome, , Italy

Site Status NOT_YET_RECRUITING

Azienda Sanitaria Universitaria Giuliano Isontina [ASUGI]

Trieste, , Italy

Site Status NOT_YET_RECRUITING

Countries

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Italy

Central Contacts

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Piergiuseppe Agostoni, Prof.

Role: CONTACT

+39 0258002772

Facility Contacts

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Piergiuseppe Agostoni

Role: primary

0258002010

Damiano Magrì, MD

Role: primary

Gianfranco Sinagra, Prof

Role: primary

Other Identifiers

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CCM 1750

Identifier Type: -

Identifier Source: org_study_id

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