Non-invasive Ventilation in Patients With Cardiac Heart Failure
NCT ID: NCT05433610
Last Updated: 2022-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2022-06-28
2022-12-05
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Constant Treadmill Load Test (CTLT) using non-invasive ventilation (NIV)
Exercise capacity testing using PS in HF patients
Non-invasive Ventilation
Exercise capacity testing using the device
Constant Treadmill Load Test (CTLT) using NIV
Exercise capacity testing using CPAP in HF patients
Non-invasive Ventilation
Exercise capacity testing using the device
Constant Treadmill Load Test (CTLT) without NIV
Exercise capacity testing without NIV in HF patients
Non-invasive Ventilation
Exercise capacity testing using the device
Interventions
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Non-invasive Ventilation
Exercise capacity testing using the device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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University of Gran Rosario
OTHER
Responsible Party
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Guillermo A. Mazzucco
Principal Investigator
Locations
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University of Gran Rosario
Rosario, Santa Fe Province, Argentina
Countries
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References
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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.
Bittencourt 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.
Gosker 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.
Borghi-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.
Mazzucco 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.
Other Identifiers
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344/2021
Identifier Type: -
Identifier Source: org_study_id