title: EaRly-start ExerciSe training afTer acute hemodynAmic decompensation in patients with chRonic hearT failure (RE-START). A multicenter, randomized, controlled trial on short-term feasibility and impact on functional capacity, symptoms and neurohumoral activation .
abstract: RE-START is a multicenter, randomized, prospective, open, controlled trial aiming to evaluate the feasibility and the short- and medium-term effects of an early-start 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/mI 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-min WT 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.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Mezzani
authors.forename: Francesco
authors.initials: F
authors.lastname: Cacciatore
authors.forename: Raffaella
authors.initials: R
authors.lastname: Catanzaro
authors.forename: Alessandra
authors.initials: A
authors.lastname: Gualco
authors.forename: Daniela
authors.initials: D
authors.lastname: Guzzetti
authors.forename: Dario
authors.initials: D
authors.lastname: Leosco
authors.forename: Mauro
authors.initials: M
authors.lastname: Monelli
authors.forename: Franco
authors.initials: F
authors.lastname: Tarro Genta
authors.forename: Paolo
authors.initials: P
authors.lastname: Totaro
authors.forename: Egidio
authors.initials: E
authors.lastname: Traversi
authors.forename: Emanuela
authors.initials: E
authors.lastname: Zanelli
authors.forename: Pantaleo
authors.initials: P
authors.lastname: Giannuzzi
mesh_terms: D002908:Chronic Disease; D005081:Exercise Therapy / Q000379:methods*; D005240:Feasibility Studies; D006333:Heart Failure / Q000503:physiopathology / Q000534:rehabilitation*; D006439:Hemodynamics; D006801:Humans; D013564:Sympathetic Nervous System / Q000503:physiopathology