ABSTRACT
Background: Water retention leading to worsening congestion is a common reason for heart failure (HF) hospitalisation. Increases in aldosterone, due to increased secretion (driven by angiotensin and hyperkalaemia) and reduced degradation (due to hepatic dysfunction), contribute to congestion. Mineralocorticoid receptor antagonists (MRA) reduce morbidity and mortality in advanced HF. However, use of MRA is often limited by hyperkalaemia, renal dysfunction and hypotension. Hyperkalaemia can be corrected by potassium binding agents. Methods: An open-label, randomised, multi-centre (up to 100 UK sites) trial investigating the use of a potassium binding agent, patiromer, to facilitate higher doses of MRA for HF with worsening congestion requiring treatment with ≥80mg/day of furosemide (or equivalent). Patients are first entered on an unconsented screening-log (approved by the UK Health Research Authority) and then asked to consent to a registry (no exclusion criteria). If they agree, and are eligible (systolic blood pressure ≥90mmHg, eGFR ≥30mL/min/1.73 m2, no other terminal disease, no active infection or myocardial ischaemia), they are invited to participate in a randomised trial. Patients who consent for the trial enter a run-in phase of ≤35 days, when they receive ≤100mg/day of spironolactone. If serum potassium rises to >5.0mmol/L, the patient is randomised either to receive an MRA at guideline recommended doses or to have spironolactone increased ≤200mg/day, using patiromer to manage hyperkalaemia, providing eGFR remains ≥30mL/min and the patient does not become hypotensive. The primary outcome of the first phase of the trial (n = 400) is severity of congestion at 60-days but patients will be followed The RELIEHF Registry & Randomised Trial long-term for morbidity and mortality. An adaptive trial design allows recruitment to be increased up to 2.000 patients. Results: The conduct of the trial has been disrupted by COVID. As of January 2022, from 10 sites, >300 patients (40% women;median age 76 (65-83) years have been screened, >100 (37% women;median age 72 (62-80) years) have consented for the registry and >25 for the randomised trial. Of patients screened, about 50% were asked for registry-consent, of whom one third refused. The main reason for not asking was that the care-team considered it inappropriate due to patient frailty and/or cognitive dysfunction. Most patients who consented for the registry agreed, in principle, to participate in a randomised trial. Most patients have tolerated 100mg of spironolactone during the run-in period. Conclusions: For a high proportion of patients admitted to hospital with worsening HF, research staff do not deem it appropriate to approach them to ask for research consent. Most patients with HF who were asked to participate in research were willing to do so and to participate in a randomised trial, although a substantial proportion were not eligible for this trial. Of those who were, the majority tolerated spironolactone at a dose of 100mg/day.
ABSTRACT
Introduction: COVID 19 is a global pandemic that has stretched healthcare resources. We explored the shift in patient demographics and clinical management of systolic heart failure (HF) patients during the COVID 19 outbreak. Purpose: To examine the impact of COVID 19 on the hospitalization rates of decompensated systolic HF patients in a tertiary hospital in Asia and delineate differences in the clinical characteristics and management of these patients. Methods: Data was extracted from the admission registry for systolic HF patients admitted to the tertiary hospital from January to June 2019 (pre- COVID) and the corresponding time period in 2020 during the COVID outbreak. We compared the demographics, clinical management and outcomes of these patients. Results: There was a significant reduction in patients admitted for systolic HF during the COVID period, 174 (6.3%) compared to 240 (8.5%) pre- COVID (p=0.001). The baseline demographics were similar except for the age of patients admitted during the COVID 19 period, which were younger at 66.1±13.5 compared to 69.9±13.9 pre-COVID (p=0.007). The mean left ventricular ejection fraction (LVEF) was lower during the COVID period (22.9±10.1% vs 24.9±10.1%;p=0.032). More patients during the COVID period were placed on mineralocorticoid receptor antagonists (p=0.001) and SGLT2 inhibitors (p<0.001). For those with recurrent admission for systolic HF, the number for HF admissions in the preceding one year was lower during COVID period compared to pre-COVID (0.2±0.5 vs 0.5±1.0 readmissions, p<0.001). There was no COVID 19 infection among those admitted for systolic HF. The 30-day all-cause mortality and readmission rates were comparable between both groups. Cardiac related mortalities were higher during the COVID 19 period compared to the pre-COVID period (77.8% vs 100.0%, p=1.000). No difference was observed in the length of stay nor proportion of patients who required a higher level of care in high dependency or intensive care unit during the COVID outbreak. Those who were admitted during the COVID period were more likely first presentation of decompensated systolic HF, 119 (68.4%) compared to 135 (56.3%) pre-COVID (p=0.014). Conclusion: Similar to the existing publications, there was a reduction in patients admitted for HF during the COVID period. However, for those who were admitted, these patients were younger and had lower LVEF. Most of them were first diagnosed with systolic HF during the hospitalizations. For those who had previous history of systolic HF, they had a lower number of HF admissions in the preceding one year compared to those who were admitted during the pre-COVID period. There was no difference in the 30-day mortality and utilization of high dependency or intensive care unit during the COVID outbreak.