Non-invasive Ventilation in Patients With Cardiac Heart Failure

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.