The Year in Cardiology

Heart Failure: the Year in Cardiology 2019

John G.F. Cleland; Alexander R. Lyon; Theresa McDonagh; John J.V. McMurray


Eur Heart J. 2020;41(12):1232-1248. 

In This Article

Acute Heart Failure

Two large RCTs of serelaxin failed to confirm the results of the original RELAX-AHF trial. RELAX-AHF-EU,[124] an open-label RCT (n = 2688), reported a similar and low rate for mortality (≤2%) and re-admissions for heart failure (<1%) at 14 days for patients assigned placebo or serelaxin, despite a reduction in worsening heart failure at day 5 [6.7–4.5% (P < 0.008)]. The RELAX-AHF-2 trial,[125] a double-blind RCT (n = 6545), reported that the rates of worsening heart failure in the first 5 days (about 7%) and 180-day mortality (about 11%) were similar for placebo and serelaxin. The failure of so many short-term interventions for AHF may reflect failed therapeutic concepts, ineffective interventions, or problems with trial design. RCTs of AHF are difficult to implement, especially if conducted double-blind. Indeed, GALACTIC, a trial of personalized, early intensive and sustained vasodilation with nitrates and hydralazine, also failed to show benefit, calling into question the concept of vasodilator therapy for the routine management of acute heart failure.[126] Many patients present with acute breathlessness in the middle of the night. It is difficult to have research staff available '24/7' when there is no 'gateway' similar to a coronary care unit or catheter laboratory. Compassionate investigators may also be unwilling to enrol frail elderly patients who are most at risk of adverse outcomes. Moreover, breathlessness usually responds to oxygen and diuretics within hours,[127] especially for patients with a systolic blood pressure ≥125 mmHg, as required in the serelaxin trials. On the other hand, patients with extensive peripheral oedema,[26] renal dysfunction, and a low blood pressure, who often do not constitute an acute emergency have a poor prognosis and an unmet need for more effective interventions; pharmacological, or device.[127,128]