COPD, Heart Failure
Conditions
Brief 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.
Interventions
DEVICERespiratory 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)
Sponsors
Centro Cardiologico Monzino
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of differences in VO2 expressed in mL/min/kg | 2 weeks | 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. |
| Evaluation of differences in ventilation expressed as L/min | 2 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of differences in heart rate (beats/min) | 2 weeks | 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. |
| Evaluation of differences in dyspnea (Borg scale) | 2 weeks | 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. |
| Evaluation of differences in peripheral saturation (%) | 2 weeks | Differences in peripheral saturation under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients.. |
| Evaluation of differences in cardiorespiratory parameters during sleep: nocturnal hypopnea (number of events) | 2 weeks | 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.. |
| Evaluation of differences in nocturnal desaturation (%) | 2 weeks | Differences in nocturnal desaturation under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients.. |
| Evaluation of differences in cardiorespiratory parameters during sleep: nocturnal apneas (number of events) | 2 weeks | Differences in nocturnal apneas under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients.. |
| Evaluation of differences in VE/VCO2 (slope during the exercise) | 2 weeks | 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. |
Countries
Italy
Outcome results
None listed