Study objective: We perform a feasibility and outcome assessment of the treatment of severe decompensated heart failure with high-dose nitroglycerin.
Methods: This study was designed as a nonrandomized, open-label, single-arm study of high-dose nitroglycerin. Patients with hypertension (systolic blood pressure > or = 160 mm Hg or mean arterial pressure > or = 120 mm Hg) who were refractory to initial therapy were eligible for inclusion. Enrolled patients began receiving a titratable nitroglycerin infusion and were given a bolus of high-dose nitroglycerin (2 mg). Repeated administration of high-dose nitroglycerin was allowed every 3 minutes, up to a total of 10 doses. Predefined effectiveness and safety outcomes were tracked throughout hospital admission. To provide a frame of reference for these outcomes, data were retrospectively compiled for similar patients with severe decompensated heart failure who did not receive high-dose nitroglycerin.
Results: Twenty-nine patients received high-dose nitroglycerin. Endotracheal intubation was required in 13.8% of patients, bilevel positive airway pressure (BiPAP) ventilation in 6.9%, and ICU admission in 37.9%. Symptomatic hypotension developed in 1 patient (3.4%), and biomarker evidence of myocardial infarction was found in 17.2% of patients. The mean dose of high-dose nitroglycerin was 6.5 mg (+/-3.4). For patients who were treated without high-dose nitroglycerin (n=45), endotracheal intubation occurred in 26.7%, BiPAP in 20.0%, and ICU admission in 80.0%. None of these patients developed symptomatic hypotension, and biomarker evidence of myocardial infarction was observed in 28.9% of patients.
Conclusion: In this nonrandomized, open-label trial, high-dose nitroglycerin was associated with endotracheal intubation, BiPAP, and ICU admission less frequently than expected to occur without high-dose nitroglycerin, and adverse events were uncommon. Treatment of hypertensive, severely decompensated heart failure patients with high-dose nitroglycerin seems promising, but a randomized, blinded study is needed to more completely define its clinical utility. According to this trial, such a study seems feasible.