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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
Mezzani A, Cacciatore F, Catanzaro R, Gualco A, Guzzetti D, Leosco D, Monelli M, Tarro Genta F, Totaro P, Traversi E, Zanelli E, Giannuzzi P
Monaldi Archives for Chest Disease 2014 Mar;82(1):20-22
clinical trial
1/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: No; Point estimates and variability: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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 > 1,000 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 to 2: active/passive mobilization (2 sessions/day, each 30 minutes duration); days 3 to 4: as days 1 to 2 plus unloaded bedside cycle ergometer (3 sessions/day, each 5 to 10 minutes duration); days 5 to 8: as days 1 to 2 plus unloaded bedside cycle ergometer (3 sessions/day, each 15 to 20 minutes duration); days 9 to 12: as days 1 to 2 plus bedside cycle ergometer at 10 to 20 W (3 sessions/day, each 15 to 20 minutes duration). During the same period, C will undergo the same activity protocol as in days 1 to 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.

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