Effect of the Use of Protective Masks on the Ability to Perform Daily Activities in Patients With Heart Failure or Obstructive Pulmonary Disease

Heart Failure Clinical Trial

Official title:

Effect of the Use of Protective Masks on the Ability to Perform Daily Activities in Patients With Heart Failure or Obstructive Pulmonary Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05762406
• Other study ID #: CCM1550
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2023
• Source: Centro Cardiologico Monzino
• Contact: Piergiuseppe Agostoni, Prof
• Phone: 0258002772
• Email: piergiuseppe.agostoni[@]ccfm.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Scientific Rationale: In late 2019 and early 2020, researchers at the Wuhan Institute of Virology identified a potential new etiologic agent, called new coronavirus 2019 (nCoV-2019). Subsequently, the epidemic unleashed by this virus involved the whole world and radically changed the habits of the entire global population. Since that time, in fact, the need to contain the spread of infection through specific social distancing procedures and through the use of personal protective equipment has become compelling. The main tool was the requirement for all citizens to wear masks for airway protection. This measure has thus become in daily use for the majority of the population. Therefore, it has become increasingly important to evaluate the impact of mask wearing on activities of daily living (ADls), both in healthy subjects, for which several evidences have already been brought, and in patients with different diseases, for which data are still insufficient to fully describe the effects. Oxygen consumption and dyspnea during simple activities of daily living (ADLs) have already been studied in patients with heart failure (HF) and chronic obstructive pulmonary disease (COPD), and there is evidence that these subjects compared with healthy subjects perform ADLs at a higher percentage of their peak VO2 with more dyspnea. However, there are still no studies highlighting, however, the consequences of performing such activities while wearing a protective filtering facepiece particles class 2 (FFP2) mask, to date considered the most suitable to preserve the most fragile subjects from infection. In this study, therefore, the investigators aim to asess the effects of these devices on the ability to perform ADLs by evaluating the exchanges of respiratory gases in the body during the performance of normal activities or during sleep in patients with HF or COPD compared with healthy subjects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Healthy subjects:

• Age: 18-80 years
• Not taking cardiovascular medications
• No history of cardiovascular disease
• Normal physical examination
• Normal ECG

Inclusion criteria for subjects with HF:

• Age: 18-80 years
• New York Heart Association Class (NYHA) II to III in stable clinical condition
• Left ventricular ejection fraction (LVEF) <40%
• Ability to perform a maximal CPET

Patients with COPD:

• Age: 18-80 years
• Diagnosis of COPD stage GOLD II-III in stable clinical condition
• Absent concomitant heart disease
• Ability to perform a maximal CPET

Exclusion Criteria:

• Healthy subjects:
• Presence of concomitant diseases

Patients:

• Oxygen therapy
• Inability or contraindication to perform a maximal CPET

Related Conditions & MeSH terms

• COPD
• Heart Failure
• Lung Diseases, Obstructive

Intervention

Device:
• Respiratory protective mask
Subjects will perform a cardiopulmonary exercise test (CPET) and a series of standardized daily activities while wearing a protective mask. During the exercises, oxygen consumption, ventilation and other cardiorespiratory parameters will be assessed using a portable device (K5, Cosmed)

Locations

Country	Name	City	State
Italy	Centro Cardiologico Monzino, Irccs	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Centro Cardiologico Monzino

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of differences in VO2 expressed in mL/min/kg	Differences in oxygen consumption (VO2) in different daily activities under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients.	2 weeks
Primary	Evaluation of differences in ventilation expressed as L/min	Differences in ventilation (VE) in different daily activities under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients.	2 weeks
Secondary	Evaluation of differences in peripheral saturation (%)	Differences in peripheral saturation under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients..	2 weeks
Secondary	Evaluation of differences in VE/VCO2 (slope during the exercise)	Differences in ventilation/carbon dioxide(VE/VCO2)slope under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients.	2 weeks
Secondary	Evaluation of differences in heart rate (beats/min)	Differences in heart rate (HR) under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients.	2 weeks
Secondary	Evaluation of differences in dyspnea (Borg scale)	Differences in dyspnea grade evaluated by Borg scale under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients.	2 weeks
Secondary	Evaluation of differences in cardiorespiratory parameters during sleep: nocturnal apneas (number of events)	Differences in nocturnal apneas under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients..	2 weeks
Secondary	Evaluation of differences in cardiorespiratory parameters during sleep: nocturnal hypopnea (number of events)	Differences in nocturnal hypopneas events under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients..	2 weeks
Secondary	Evaluation of differences in nocturnal desaturation (%)	Differences in nocturnal desaturation under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients..	2 weeks