Heart FailureNCT05762406
Effect of the Use of Protective Masks on the Ability to Perform Daily Activities in Patients with Heart Failure or Obstructive Pulmonary Disease
A study testing Respiratory protective mask in people with Heart Failure and COPD, run by Centro Cardiologico Monzino at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, COPD
- What is being tested?
- Respiratory protective mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 16 Jun 2021to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects:
- Age: 18-80 years
- Not taking cardiovascular medications
- No history of cardiovascular disease
- Normal physical examination
- Normal ECG
Show all 15Show fewer
- 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
Who cannot join
- Healthy subjects:
- Presence of concomitant diseases
- Patients:
- Oxygen therapy
- Inability or contraindication to perform a maximal CPET
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Heart Failure, COPD
- Being tested
- Respiratory protective mask
- Medical subject headings
- Heart Failure, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory protective maskDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| Wearing mask | Experimental | Subjects will perform a cardiopulmonary exercise test (CPET) and a series of standardized daily activities while wearing a protective mask Receives: Device: Respiratory protective mask |
| Not wearing mask | No intervention | Subjects will perform a cardiopulmonary exercise test (CPET) and a series of standardized daily activities in basal conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
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.
Measured: 2 weeks
Secondary outcomes (7)
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..
Measured: 2 weeks
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.
Measured: 2 weeks
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.
Measured: 2 weeks
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.
Measured: 2 weeks
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..
Measured: 2 weeks
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..
Measured: 2 weeks
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..
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start16 Jun 2021
- Primary completion15 Mar 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762406
- Sponsor's protocol ID
- CCM1550
- Status last verified
- Aug 2024
- First submitted
- 16 Feb 2023
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05762406
- Acronym / sponsor ID
- CCM1550
- Conditions
- Heart Failure, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wearing mask | Experimental | Device: Respiratory protective maskSubjects will perform a cardiopulmonary exercise test (CPET) and a series of standardized daily activities while wearing a protective mask |
| Not wearing mask | No intervention | –Subjects will perform a cardiopulmonary exercise test (CPET) and a series of standardized daily activities in basal conditions |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age: 18-80 years
- Not taking cardiovascular medications
- No history of cardiovascular disease
- Normal physical examination
- Normal ECG
Key exclusion criteria (5 listed)
- Healthy subjects:
- Presence of concomitant diseases
- Oxygen therapy
- Inability or contraindication to perform a maximal CPET
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory protective maskSubjects 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) | Device | Wearing mask |
Primary outcome
Evaluation of differences in VO2 expressed in mL/min/kg
Time frame: 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
Time frame: 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.
7 secondary outcomes
Evaluation of differences in peripheral saturation (%)
Time frame: 2 weeks
Evaluation of differences in VE/VCO2 (slope during the exercise)
Time frame: 2 weeks
Evaluation of differences in heart rate (beats/min)
Time frame: 2 weeks
Evaluation of differences in dyspnea (Borg scale)
Time frame: 2 weeks
Evaluation of differences in cardiorespiratory parameters during sleep: nocturnal apneas (number of events)
Time frame: 2 weeks
Evaluation of differences in cardiorespiratory parameters during sleep: nocturnal hypopnea (number of events)
Time frame: 2 weeks
Evaluation of differences in nocturnal desaturation (%)
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory protective mask in people with Heart Failure and COPD, run by Centro Cardiologico Monzino at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of differences in VO2 expressed in mL/min/kg (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2024.