Abstract
Aims: During the coronavirus disease 2019 (COVID-19) pandemic, important changes in heart failure (HF) event rates have been widely reported, but few data address potential causes for these changes; several possibilities were examined in the GUIDE-HF study.
Methods and results: From 15 March 2018 to 20 December 2019, patients were randomized to haemodynamic-guided management (treatment) vs. control for 12 months, with a primary endpoint of all-cause mortality plus HF events. Pre-COVID-19, the primary endpoint rate was 0.553 vs. 0.682 events/patient-year in the treatment vs. control group [hazard ratio (HR) 0.81, P = 0.049]. Treatment difference was no longer evident during COVID-19 (HR 1.11, P = 0.526), with a 21% decrease in the control group (0.536 events/patient-year) and no change in the treatment group (0.597 events/patient-year). Data reflecting provider-, disease-, and patient-dependent factors that might change the primary endpoint rate during COVID-19 were examined. Subject contact frequency was similar in the treatment vs. control group before and during COVID-19. During COVID-19, the monthly rate of medication changes fell 19.2% in the treatment vs. 10.7% in the control group to levels not different between groups (P = 0.362). COVID-19 was infrequent and not different between groups. Pulmonary artery pressure area under the curve decreased -98 mmHg-days in the treatment group vs. -100 mmHg-days in the controls (P = 0.867). Patient compliance with the study protocol was maintained during COVID-19 in both groups.
Conclusion: During COVID-19, the primary event rate decreased in the controls and remained low in the treatment group, resulting in an effacement of group differences that were present pre-COVID-19. These outcomes did not result from changes in provider- or disease-dependent factors; pulmonary artery pressure decreased despite fewer medication changes, suggesting that patient-dependent factors played an important role in these outcomes. Clinical Trials.gov: NCT03387813 .
Keywords: COVID-19; Haemodynamics; Heart failure; Pulmonary artery pressure.
【저자키워드】 COVID-19, heart failure, Haemodynamics, Pulmonary artery pressure., 【초록키워드】 Treatment, coronavirus disease, pandemic, Study protocol, outcome, outcomes, Randomized, heart, clinical, management, Patient, Compliance, Control, group, medication, change, Frequency, primary endpoint, Contact, pulmonary artery, pulmonary artery pressure, changes, Factor, control group, all-cause mortality, treatment group, event rate, decrease, resulting, examined, reported, remained, events, changes in, cause, groups, not different, in both groups, primary event rate, the primary endpoint, 【제목키워드】 Trial, COVID-19 pandemic, pulmonary artery pressure,