- Figure 32
ADVENT-HF: Trial Design 1
FIG. 32: Turning to the ADVENT-HF trial, it is investigator-initiated and is academically sponsored by the University Health Network in Toronto, with additional funding from Philips Respironics, which provided the ASV device.[12] Philips Respironics had no role in the design, conduct, or management of the data of this trial, and will have no involvement in publication of the results.
ADVENT-HF is enrolling patients with heart failure with reduced LVEF (≤45%), and either CSA or OSA (patients with OSA must have no or mild sleepiness, ie, they should not have an indication to be treated).
Our hypothesis is that OSA has a greater potential to improve heart failure outcomes than CSA because of its elimination of the negative intrathoracic pressure, which (as reviewed in Figures 6–8, above) is associated with significant overnight falls in stroke volume and cardiac output in OSA but not CSA.
The denominator for the AHI is sleep time, since all patients undergo a full polysomnogram (PSG). All subjects have PSGs scored centrally in the Toronto Rehabilitation Institute’s sleep laboratory, and as principal investigator I read every PSG study, so the scoring is done consistently. Unlike SERVE-HF, LVEF in ADVENT-HF is determined prospectively by a study-mandated echocardiogram, and all echocardiography laboratories have to be certified by our central institution to verify that the quality of their echocardiograms meets study standards.
References
Effect of Adaptive Servo Ventilation (ASV) on Survival and Hospital Admissions in Heart Failure (ADVENT-HF). ClinicalTrials.gov Identifier: NCT01128816. https://clinicaltrials.gov/show/NCT01128816