Non-invasive Ventilation in Patients With Cardiac Heart Failure

Heart Failure Clinical Trial

Official title:

Is Non-invasive Ventilation Effective in Improving the Exercise Capacity in Patients With Cardiac Heart Failure?: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05433610
• Other study ID #: 344/2021
• Status: Completed
• Phase: N/A
• Start date: June 28, 2022
• Est. completion date: December 5, 2022

Study information

• Verified date: December 2022
• Source: University of Gran Rosario
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 5, 2022
• Est. primary completion date: December 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Non-invasive Ventilation
Exercise capacity testing using the device

Locations

Country	Name	City	State
Argentina	University of Gran Rosario	Rosario	Santa Fe

Sponsors (1)

Lead Sponsor	Collaborator
University of Gran Rosario

Country where clinical trial is conducted

Argentina, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At the end of exercise
Secondary	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.	At the end of exercise
Secondary	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	At the end of exercise
Secondary	Change in Oxygen Saturation	Change in Oxygen Saturation using a pulse oximetry (Masimo Radical 7) between PS, CPAP and WNIT	At the end of exercise
Secondary	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.	At the end of exercise
Secondary	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.	At the end of exercise
Secondary	Change in Blood Pressure	Change in Systolic and Dyastolic blood preassure in mmHg at the beginning and at the end.	At the end of exercise
Secondary	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)	At the end of exercise
Secondary	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.	At the end of exercise