A multicenter, randomized, controlled trial on short-term feasibility and impact on functional capacity, symptoms and neurohumoral activation

Submitted: August 19, 2015
Accepted: August 19, 2015
Published: August 19, 2015
Abstract Views: 2658
PDF: 1180
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RE-START is a multicenter, randomized, prospective, open, controlled trial aiming to evaluate the feasibility and the short- and medium-term effects of an earlystart AET program on functional capacity, symptoms and neurohormonal activation in chronic heart failure (CHF) patients with recent acute hemodynamic decompensation. Study endpoints will be: 1) safety of and compliance to AET; 2) effects of AET on i) functional capacity, ii) patient- reported symptoms and iii) AET-induced changes in beta-adrenergic receptor signaling and circulating angiogenetic and inflammatory markers. Two-hundred patients, randomized 1:1 to training (TR) or control (C), will be enrolled. Inclusion criteria: 1) history of systolic CHF for at least 6 months, with ongoing acute decompensation with need of intravenous diuretic and/or vasodilator therapy; 2) proBNP >1000 pg/ml at admission. Exclusion criteria: 1) ongoing cardiogenic shock; 2) need of intravenous inotropic therapy; 3) creatinine >2.5 mg/dl at admission. After a 72-hour run-in period, TR will undergo the following 12-day early-start AET protocol: days 1-2: active/passive mobilization (2 sessions/day, each 30 minutes duration); days 3-4: as days 1-2 + unloaded bedside cycle ergometer (3 sessions/day, each 5-10 minutes duration); days 5-8: as days 1-2 + unloaded bedside cycle ergometer (3 sessions/day, each 15-20 minutes duration); days 9-12: as days 1-2 + bedside cycle ergometer at 10-20 W (3 sessions/day, each 15-20 minutes duration). During the same period, C will undergo the same activity protocol as in days 1-2 for TR. All patients will undergo a 6- minWT at day 1, 6, 12 and 30 and echocardiogram, patient- reported symptoms on 7-point Likert scale and measurement of lymphocyte G protein coupled receptor kinase, VEGF, angiopoietin, TNF alfa, IL-1, IL-6 and eNOS levels at day 1, 12 and 30.

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Mezzani, Alessandro, Francesco Cacciatore, Raffaella Catanzaro, Alessandra Gualco, Daniela Guzzetti, Dario Leosco, Mauro Monelli, Franco Tarro Genta, Paolo Totaro, Egidio Traversi, Emanuela Zanelli, and Pantaleo Giannuzzi. 2015. “A Multicenter, Randomized, Controlled Trial on Short-Term Feasibility and Impact on Functional Capacity, Symptoms and Neurohumoral Activation”. Monaldi Archives for Chest Disease 82 (1). https://doi.org/10.4081/monaldi.2014.38.