Exercise Oxygen Kinetic and Cardiac Output in Hypertrophic Cardiomyopathy

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

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 Overview

• Status: Recruiting
• Conditions: Hypertrophic Cardiomyopathy; Cardiopulmonary Exercise Test; Cardiac Output Measurement

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

• Study Contact: Name: Piergiuseppe Agostoni, Prof.; Phone Number: +39 0258002772; Email: piergiuseppe.agostoni@ccfm.it

Study Locations

• Italy
  • Milano, Italy, 20138
    • Recruiting
    • Centro Cardiologico Monzino, IRCCS
    • Contact: Piergiuseppe Agostoni; Phone Number: 0258002010; Email: piergiuseppe.agostoni@ccfm.it
  • Rome, Italy
    • Not yet recruiting
    • Azienda Ospedaliera Sant'Andrea
    • Contact: Damiano Magrì, MD
  • Trieste, Italy
    • Not yet recruiting
    • Azienda Sanitaria Universitaria Giuliano Isontina [ASUGI]
    • Contact: Gianfranco Sinagra, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation with echocardiographic variables	Correlate functional and metabolic data with echocardiographic variables collected at rest and under stress.	immediately after the evaluation

Collaborators and Investigators

• Sponsor: Centro Cardiologico Monzino
• Collaborators: Azienda Ospedaliera "Sant'Andrea"; Azienda Sanitaria Universitaria Giuliano Isontina [ASUGI], Università di Trieste, Italy
• Investigators: Principal Investigator: Piergiuseppe Agostoni, Prof., Centro Cardiologico Monzino

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2022
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: February 15, 2023
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Hypertrophy; Cardiomyopathies; Cardiomyopathy, Hypertrophic
• Other Study ID Numbers: CCM 1750

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No