Exercise Oxygen Kinetic and Cardiac Output in Hypertrophic Cardiomyopathy

Sponsor
Centro Cardiologico Monzino (Other)
Overall Status
Recruiting
CT.gov ID
NCT05754489
Collaborator
Azienda Sanitaria Universitaria Giuliano Isontina [ASUGI], Università di Trieste, Italy (Other), Azienda Ospedaliera "Sant'Andrea" (Other)
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Study Details

Study Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
90 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Exercise Oxygen Kinetic and Cardiac Output in Hypertrophic Cardiomyopathy: a Multicenter Prospective Cardiopulmonary Exercise Testing Study
Actual Study Start Date :
Apr 20, 2022
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Outcome Measures

Primary Outcome Measures

  1. cardiac output measurement [immediately after the evaluation]

    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.

Secondary Outcome Measures

  1. Correlation with echocardiographic variables [immediately after the evaluation]

    Correlate functional and metabolic data with echocardiographic variables collected at rest and under stress.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centro Cardiologico Monzino, Irccs Milano Italy 20138
2 Azienda Ospedaliera Sant'Andrea Rome Italy
3 Azienda Sanitaria Universitaria Giuliano Isontina [ASUGI] Trieste Italy

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Piergiuseppe Agostoni, Prof., Centro Cardiologico Monzino

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centro Cardiologico Monzino
ClinicalTrials.gov Identifier:
NCT05754489
Other Study ID Numbers:
  • CCM 1750
First Posted:
Mar 3, 2023
Last Update Posted:
Mar 3, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 3, 2023