Exercise Oxygen Kinetic and Cardiac Output in Hypertrophic Cardiomyopathy

NCT05754489 | Unknown

• 1 other identifier: CCM 1750
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 3

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.

Conditions

Cardiopulmonary Exercise Test; Hypertrophic Cardiomyopathy; Cardiac Output Measurement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation with echocardiographic variables

  immediately after the evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with a previous diagnosis of hypertrophic cardiomyopathy in optimised medical therapy will be enrolled

You may qualify if:

• hypertrophic cardiomyopathy diagnosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Cardiologico Monzino: lead
• Azienda Sanitaria Universitaria Giuliano Isontina [ASUGI], Università di Trieste, Italy: collaborator
• Azienda Ospedaliera "Sant'Andrea": collaborator

Study Sites (3)

Centro Cardiologico Monzino, Irccs

Milan, 20138, Italy

RECRUITING

Azienda Ospedaliera Sant'Andrea

Rome, Italy

NOT YET RECRUITING

Azienda Sanitaria Universitaria Giuliano Isontina [ASUGI]

Trieste, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Piergiuseppe Agostoni, Prof.

  Centro Cardiologico Monzino

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piergiuseppe Agostoni, Prof.

CONTACT

+39 0258002772; piergiuseppe.agostoni@ccfm.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 3, 2023
• Study Start: April 20, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: March 3, 2023

Record last verified: 2023-02

Locations

IT (3)