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

https://doi.org/10.4081/monaldi.2014.38

Authors

  • Alessandro Mezzani | alessandro.mezzani@fsm.it Fondazione S. Maugeri, IRCCS - Istituto Scientifico di Veruno (NO) - Divisione di Cardiologia Riabilitativa, Italy.
  • Francesco Cacciatore Fondazione S. Maugeri, IRCCS - Istituto Scientifico di Campoli/Telese (BN) - Divisione di Cardiologia Riabilitativa, Italy.
  • Raffaella Catanzaro Fondazione S. Maugeri, IRCCS - Istituto Scientifico di Cassano Murge (BA) - Divisione di Cardiologia Riabilitativa, Italy.
  • Alessandra Gualco Fondazione S. Maugeri, IRCCS - Istituto Scientifico di Pavia - Divisione di Cardiologia Riabilitativa, Italy.
  • Daniela Guzzetti Fondazione S. Maugeri, IRCCS - Istituto Scientifico di Tradate (VA) - Dipartimento di Medicina e Riabilitazione Cardiorespiratoria, Italy.
  • Dario Leosco Università Federico II di Napoli - Cattedra di Geriatria, Italy.
  • Mauro Monelli Fondazione S. Maugeri, IRCCS - Istituto Scientifico di Milano - Unità Operativa di Cure Subacute, Italy.
  • Franco Tarro Genta Fondazione S. Maugeri, IRCCS - Presidio Ospedaliero Major (TO) - Divisione di Cardiologia Riabilitativa, Italy.
  • Paolo Totaro Fondazione S. Maugeri, IRCCS - Istituto Scientifico di Milano - Unità Operativa di Riabilitazione Specialistica Cardiologica, Italy.
  • Egidio Traversi Fondazione S. Maugeri, IRCCS - Istituto Scientifico di Montescano (PV) - Divisione di Cardiologia Riabilitativa, Italy.
  • Emanuela Zanelli Fondazione S. Maugeri, IRCCS - Istituto Scientifico di Lumezzane (BS) - Divisione di Cardiologia Riabilitativa, Italy.
  • Pantaleo Giannuzzi Fondazione S. Maugeri, IRCCS - Istituto Scientifico di Veruno (NO) - Divisione di Cardiologia Riabilitativa, Italy.

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 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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Published
2015-08-19
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Original Articles
Keywords:
chronic heart failure, hemodynamic decompensation, physical training, functional capacity, neurohumoral activation
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How to Cite
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.

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