Heart FailureNCT05433610
Non-invasive Ventilation in Patients With Cardiac Heart Failure
A study testing Non-invasive Ventilation in people with Heart Failure, run by University of Gran Rosario at 1 site in Argentina.
Trial summary
Patients with heart failure (HF) have a reduced exercise tolerance as the main result of the disease. This exercise intolerance is due to heart conditions, but also to dysfunction of the respiratory and peripheral muscles. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Non-invasive Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteArgentina
- Study dates
- 28 Jun 2022to 5 Dec 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ejection fraction demonstrated by echocardiography ≤ 40% (in the last 12 months).
- NYHA functional class I - III.
- Clinical stability, defined as four weeks prior to the start of the study without hospitalizations.
- Signed informed consent.
- ≥ 18 years of age.
Who cannot join
- Chronic obstructive pulmonary disease (COPD), unstable angina or significant arrhythmias.
- Myocardial infarction in the last 3 months, primary valve disease and anemia (hemoglobin under 13 g/dl for men or 12 g/dl for women).
- Patients who are smokers or ex-smokers of less than one year.
- Patients with cognitive impairment that prevents the correct understanding of the evaluations.
- Any neuromuscular or osteoarticular condition that limits test performance.
- Refusal to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Non-invasive Ventilation Effective in Improving the Exercise Capacity in Patients With Cardiac Heart Failure?: A Randomized Controlled Trial
Patients with heart failure (HF) have a reduced exercise tolerance as the main result of the disease. This exercise intolerance is due to heart conditions, but also to dysfunction of the respiratory and peripheral muscles. Various factors such as chronic hypoxia, oxidative stress, nutritional depletion, peripheral muscle disuse, effects of medications, and sympathetic-vagal imbalance are major contributors to deconditioning. In this scenario, the use of non-invasive ventilatory support (NIV) arises as an adjunct to cardiac rehabilitation in the attempt to improve the functional capacity of patients, since NIV reduces work of breathing, improves oxygenation and increases lung compliance associated with improved ejection volume, due to increased intrathoracic pressure.
Read the detailed description
The main objective is to evaluate whether the use of NIV during Constant Treadmill Load Tests (CTLT) enhances exercise performance in Cardiac Heart Failure (CHF) patients on a treadmill.
Each recruited patient will be evaluated on 4 occasions, with two different evaluations, an incremental test (IT) to find out the maximum aerobic speed reached and then, in randomized order, three CTLT at 85% of the maximum reached in the IT . Two of the three CTLT will be performed with the use of NIV, with PS (IPAP 10cmH2O and EPAP 5cmH2O) and CPAP (5cmH2O) mode, and the rest will be without the use of NIV. The main study variable will be the time tolerated on the treadmill during CTLT.
Participants will have 5 minutes to adapt to NIV, 5-minute warm-up at 50% and then will start with the CTLT at 85% of the maximum aerobic speed reached in the IT.
In total, each patient will be evaluated four times on four different visits.
Sample size: For the sample's calculation, the maximum time in CTLC was chosen as the main study variable because it is a sensitive measure to detect changes after interventions (both pharmacological and non-pharmacological) and widely used in clinical trials. A minimum difference to detect of 100 seconds from previous literature was determined. Taking this data into account, and using a level of α of 0.05, a 1-β power of 0.80, and an effect size of 0.8, the sample size calculation for a paired t-test investigators found that at least 12 participants are needed. The calculation was made using the Gpower 3.1.9.7 software.
- Conditions
- Heart Failure
- Being tested
- Non-invasive Ventilation
- Keywords
- Rehabilitation, Exercise Test, Heart Failure, Aerobic Exercise
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive VentilationDevice
Also called Noninvasive Ventilations
Exercise capacity testing using the device
| Study group | Role | What they receive |
|---|---|---|
| Constant Treadmill Load Test (CTLT) using non-invasive ventilation (NIV) | Experimental | Exercise capacity testing using PS in HF patients Receives: Device: Non-invasive Ventilation |
| Constant Treadmill Load Test (CTLT) using NIV | Experimental | Exercise capacity testing using CPAP in HF patients Receives: Device: Non-invasive Ventilation |
| Constant Treadmill Load Test (CTLT) without NIV | Active comparator | Exercise capacity testing without NIV in HF patients Receives: Device: Non-invasive Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in exercise tolerance
Change in Maximun Walking time tolerated in a Constant Treadmill Load Test (CTLT) in seconds on treadmill between PS, CPAP and WNIT
Measured: At the end of exercise
Secondary outcomes (8)
Change in Dyspnea
Degree of dyspnea will be determined by this validated scale with a result between 0 and 10 points.0: Not at all 0.5: Very, very light (hardly noticeable) 1: Very light, 2: Light, 3: Moderate , 4: Somewhat intense, 5: Intense, 6: Between 5 and 7, 7: Very intense, 8: Between 7 and 9, 9: Very, very intense (almost maximum ), 10: Maximum.
Measured: At the end of exercise
Change in Cardiac Rate
Difference in Cardiac Rate (beats per minute) using a pulse oximetry (Masimo Radical 7) and a heart rate monitor (Polar FT1) between PS, CPAP and WNIT
Measured: At the end of exercise
Change in Oxygen Saturation
Change in Oxygen Saturation using a pulse oximetry (Masimo Radical 7) between PS, CPAP and WNIT
Measured: At the end of exercise
Change in Global Comfort
Change in global comfort according to the device used with Visual Analogue Scale (VAS). The VAS is a 10 cm line with anchor statements on the left (very unpleasant) and on the right (very pleasant) 0-10cm.
Measured: At the end of exercise
Change in Lower Limbs Fatigue
Change in Lower limbs fatigue perception using the Modified Borg Scale (Degree of fatigue will be determined by this validated scale with a result between 0 and 10 points.0: Not at all 0.5: Very, very light (hardly noticeable) 1: Very light, 2: Light, 3: Moderate , 4: Somewhat intense, 5: Intense, 6: Between 5 and 7, 7: Very intense, 8: Between 7 and 9, 9: Very, very intense (almost maximum ), 10: Maximum.
Measured: At the end of exercise
Change in Blood Pressure
Change in Systolic and Dyastolic blood preassure in mmHg at the beginning and at the end.
Measured: At the end of exercise
Change in Recovery heart rate
Change in heart rate (beats per minute) in the first minute, in the second minute and in the third minute after the test, using pulse oximetry (Masimo Radical 7)
Measured: At the end of exercise
Change in the motive for stopping the test
Change in reason for stopping the test. A dichotomous question will be asked regarding the reason for stopping the test, whether it was due to dyspnea or lower limb fatigue.
Measured: At the end of exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start28 Jun 2022
- Primary completion5 Dec 2022
- Study completion5 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Interventional, crossover, randomized.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gran Rosario
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo A. Mazzucco, University of Gran Rosario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433610
- Sponsor's protocol ID
- 344/2021
- Status last verified
- Dec 2022
- First submitted
- 15 Jun 2022
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
O'Donnell DE, D'Arsigny C, Raj S, Abdollah H, Webb KA. Ventilatory assistance improves exercise endurance in stable congestive heart failure. Am J Respir Crit Care Med. 1999 Dec;160(6):1804-11. doi: 10.1164/ajrccm.160.6.9808134.
PubMed 10588589Bittencourt HS, Reis HF, Lima MS, Gomes M Neto. Non-Invasive Ventilation in Patients with Heart Failure: A Systematic Review and Meta-Analysis. Arq Bras Cardiol. 2017 Feb;108(2):161-168. doi: 10.5935/abc.20170001. Epub 2017 Jan 16.
PubMed 28099587Gosker HR, Wouters EF, van der Vusse GJ, Schols AM. Skeletal muscle dysfunction in chronic obstructive pulmonary disease and chronic heart failure: underlying mechanisms and therapy perspectives. Am J Clin Nutr. 2000 May;71(5):1033-47. doi: 10.1093/ajcn/71.5.1033.
PubMed 10799364Borghi-Silva A, Carrascosa C, Oliveira CC, Barroco AC, Berton DC, Vilaca D, Lira-Filho EB, Ribeiro D, Nery LE, Neder JA. Effects of respiratory muscle unloading on leg muscle oxygenation and blood volume during high-intensity exercise in chronic heart failure. Am J Physiol Heart Circ Physiol. 2008 Jun;294(6):H2465-72. doi: 10.1152/ajpheart.91520.2007. Epub 2008 Mar 28.
PubMed 18375714Mazzucco G, Torres-Castro R, Intelangelo L, Lista-Paz A, Escalante JP, Zumeta-Olaskoaga L, Veiga G, Etxarri AA. Is non-invasive ventilation effective in improving the exercise capacity in patients with cardiac heart failure?: A randomised crossover trial. PLoS One. 2025 Jul 7;20(7):e0327399. doi: 10.1371/journal.pone.0327399. eCollection 2025.
PubMed 40622949
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Non-invasive Ventilation Effective in Improving the Exercise Capacity in Patients With Cardiac Heart Failure?: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05433610
- Acronym / sponsor ID
- 344/2021
- Conditions
- Heart Failure
- Keywords
- Rehabilitation, Exercise Test, Heart Failure, Aerobic Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Gran RosarioUniversity, hospital or other
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 27 Jun 2022 (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.
Patients with heart failure (HF) have a reduced exercise tolerance as the main result of the disease. This exercise intolerance is due to heart conditions, but also to dysfunction of the respiratory and peripheral muscles. Various factors such as chronic hypoxia, oxidative stress, nutritional depletion, peripheral muscle disuse, effects of medications, and sympathetic-vagal imbalance are major contributors to deconditioning. In this scenario, the use of non-invasive ventilatory support (NIV) arises as an adjunct to cardiac rehabilitation in the attempt to improve the functional capacity of patients, since NIV reduces work of breathing, improves oxygenation and increases lung compliance associated with improved ejection volume, due to increased intrathoracic pressure.
Detailed description
The main objective is to evaluate whether the use of NIV during Constant Treadmill Load Tests (CTLT) enhances exercise performance in Cardiac Heart Failure (CHF) patients on a treadmill.
Each recruited patient will be evaluated on 4 occasions, with two different evaluations, an incremental test (IT) to find out the maximum aerobic speed reached and then, in randomized order, three CTLT at 85% of the maximum reached in the IT . Two of the three CTLT will be performed with the use of NIV, with PS (IPAP 10cmH2O and EPAP 5cmH2O) and CPAP (5cmH2O) mode, and the rest will be without the use of NIV. The main study variable will be the time tolerated on the treadmill during CTLT.
Participants will have 5 minutes to adapt to NIV, 5-minute warm-up at 50% and then will start with the CTLT at 85% of the maximum aerobic speed reached in the IT.
In total, each patient will be evaluated four times on four different visits.
Sample size: For the sample's calculation, the maximum time in CTLC was chosen as the main study variable because it is a sensitive measure to detect changes after interventions (both pharmacological and non-pharmacological) and widely used in clinical trials. A minimum difference to detect of 100 seconds from previous literature was determined. Taking this data into account, and using a level of α of 0.05, a 1-β power of 0.80, and an effect size of 0.8, the sample size calculation for a paired t-test investigators found that at least 12 participants are needed. The calculation was made using the Gpower 3.1.9.7 software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Interventional, crossover, randomized.
| Arm | Type | Receives |
|---|---|---|
| Constant Treadmill Load Test (CTLT) using non-invasive ventilation (NIV) | Experimental | Device: Non-invasive VentilationExercise capacity testing using PS in HF patients |
| Constant Treadmill Load Test (CTLT) using NIV | Experimental | Device: Non-invasive VentilationExercise capacity testing using CPAP in HF patients |
| Constant Treadmill Load Test (CTLT) without NIV | Active comparator | Device: Non-invasive VentilationExercise capacity testing without NIV in HF patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ejection fraction demonstrated by echocardiography ≤ 40% (in the last 12 months).
- NYHA functional class I - III.
- Clinical stability, defined as four weeks prior to the start of the study without hospitalizations.
- Signed informed consent.
- ≥ 18 years of age.
Key exclusion criteria (6 listed)
- Chronic obstructive pulmonary disease (COPD), unstable angina or significant arrhythmias.
- Myocardial infarction in the last 3 months, primary valve disease and anemia (hemoglobin under 13 g/dl for men or 12 g/dl for women).
- Patients who are smokers or ex-smokers of less than one year.
- Patients with cognitive impairment that prevents the correct understanding of the evaluations.
- Any neuromuscular or osteoarticular condition that limits test performance.
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 |
|---|---|---|
| Non-invasive VentilationAlso: Noninvasive VentilationsExercise capacity testing using the device | Device | Constant Treadmill Load Test (CTLT) using NIV, Constant Treadmill Load Test (CTLT) using non-invasive ventilation (NIV), Constant Treadmill Load Test (CTLT) without NIV |
Primary outcome
Change from baseline in exercise tolerance
Time frame: At the end of exercise
Change in Maximun Walking time tolerated in a Constant Treadmill Load Test (CTLT) in seconds on treadmill between PS, CPAP and WNIT
8 secondary outcomes
Change in Dyspnea
Time frame: At the end of exercise
Change in Cardiac Rate
Time frame: At the end of exercise
Change in Oxygen Saturation
Time frame: At the end of exercise
Change in Global Comfort
Time frame: At the end of exercise
Change in Lower Limbs Fatigue
Time frame: At the end of exercise
Change in Blood Pressure
Time frame: At the end of exercise
Change in Recovery heart rate
Time frame: At the end of exercise
Change in the motive for stopping the test
Time frame: At the end of exercise
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 15 Dec 2022.
- Background: PubMed 10588589O'Donnell DE, D'Arsigny C, Raj S, Abdollah H, Webb KA. Ventilatory assistance improves exercise endurance in stable congestive heart failure. Am J Respir Crit Care Med. 1999 Dec;160(6):1804-11. doi: 10.1164/ajrccm.160.6.9808134.
- Background: PubMed 28099587Bittencourt HS, Reis HF, Lima MS, Gomes M Neto. Non-Invasive Ventilation in Patients with Heart Failure: A Systematic Review and Meta-Analysis. Arq Bras Cardiol. 2017 Feb;108(2):161-168. doi: 10.5935/abc.20170001. Epub 2017 Jan 16.
- Background: PubMed 10799364Gosker HR, Wouters EF, van der Vusse GJ, Schols AM. Skeletal muscle dysfunction in chronic obstructive pulmonary disease and chronic heart failure: underlying mechanisms and therapy perspectives. Am J Clin Nutr. 2000 May;71(5):1033-47. doi: 10.1093/ajcn/71.5.1033.
- Background: PubMed 18375714Borghi-Silva A, Carrascosa C, Oliveira CC, Barroco AC, Berton DC, Vilaca D, Lira-Filho EB, Ribeiro D, Nery LE, Neder JA. Effects of respiratory muscle unloading on leg muscle oxygenation and blood volume during high-intensity exercise in chronic heart failure. Am J Physiol Heart Circ Physiol. 2008 Jun;294(6):H2465-72. doi: 10.1152/ajpheart.91520.2007. Epub 2008 Mar 28.
- Derived from this study: PubMed 40622949Mazzucco G, Torres-Castro R, Intelangelo L, Lista-Paz A, Escalante JP, Zumeta-Olaskoaga L, Veiga G, Etxarri AA. Is non-invasive ventilation effective in improving the exercise capacity in patients with cardiac heart failure?: A randomised crossover trial. PLoS One. 2025 Jul 7;20(7):e0327399. doi: 10.1371/journal.pone.0327399. eCollection 2025.
- Individual participant dataSharing planned: Yes
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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 Non-invasive Ventilation in people with Heart Failure, run by University of Gran Rosario at 1 site in Argentina.
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 5 inclusion and 6 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 15 Dec 2022. 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 Argentina. 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?
Change from baseline in exercise tolerance (time frame: At the end of exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05433610, which also lists 5 linked publications.
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 15 Dec 2022.