Early-start Exercise Training in Subacute Heart Failure

Not Applicable

• Conditions: Chronic Heart Failure; Heart Decompensation
• Interventions: Other: Standard physical therapy; Other: Aerobic exercise training

• Registration Number: NCT02051985
• Lead Sponsor: Fondazione Salvatore Maugeri

Brief Summary

The purpose of this study is to evaluate the feasibility and the short-term effects of an early-start aerobic exercise training program on functional capacity, symptoms and neurohormonal activation in chronic heart failure patients with recent acute hemodynamic decompensation.

Detailed Description

Prescription of aerobic exercise training in stable chronic heart failure patients finds an evidence-based justification in the acknowledged long-term positive effects of aerobic exercise training on both functional capacity and prognosis in this population. In recent time, evidence has accumulated in normal subjects about short-term favorable effects of aerobic exercise training on sympatho-vagal balance and flow-mediated vasodilation, two physiological mechanisms known to be profoundly altered in the setting of acute hemodynamic decompensation of chronic heart failure. The possible extension of aerobic exercise training indication to chronic heart failure patients admitted for recent acute hemodynamic decompensation not stabilized as yet, may thus provide a valuable, low-cost tool to effectively manage such a high-risk and resource-absorbing population.

Study Timeline

• Study Start: 2013-10
• Status Verified: 2014-01
• Study First Submitted: 2014-01-29
• Study First Submitted QC: 2014-01-29
• Last Update Submitted: 2014-01-29
• Study First Posted: 2014-01-31
• Last Update Posted: 2014-01-31
• Primary Completion: 2015-06
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• history of chronic heart failure for at least 6 months, with ongoing acute decompensation defined as onset or worsening of heart failure signs and/or symptoms during the previous 15 days with need of intravenous diuretic and/or vasodilator therapy;
• age >18 years
• left ventricular ejection fraction <40%
• proBNP >1000 pg/ml at admission

Exclusion Criteria

• ongoing cardiogenic shock
• need of intravenous inotropic therapy
• acute coronary syndrome during the preceding 3 months
• clinical and/or instrumental evidence of myocardial ischemia and/or life-threatening arrhythmias
• previous cardiac valve surgery
• creatinine >2.5 mg/dl at admission
• severe comorbidities limiting functional capacity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard physical therapy	Standard physical therapy	-
Aerobic exercise training	Aerobic exercise training	-

Primary Outcome Measures

Name	Time	Method
Distance walked at 6-min walking test	12 days of intervention	Change from baseline in distance walked at 6-min walking test

Secondary Outcome Measures

Name	Time	Method
Aerobic exercise training safety and tolerability	12 days of treatment	Number of participants with serious/non-serious adverse events and completing/not completing the study protocol
Levels of lymphocyte G protein-coupled receptor kinase-2	12 days of intervention	Change from baseline in lymphocyte G protein-coupled receptor kinase-2 levels
Patient-reported dyspnea, evaluated by a 7-point Likert scale	12 days of intervention	Change from baseline in patient-reported dyspnea on a 7-point Likert scale
Levels of circulating inflammatory and angiogenetic markers (TNF-alfa, Interleukin-6, Angiopoietin 2 and VEGF)	12 days of intervention	Change from baseline in circulating inflammatory and angiogenetic markers (TNF-alfa, Interleukin-6, Angiopoietin 2 and VEGF) levels

Trial Locations

Locations (9)

Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Cassano Murge; 🇮🇹 Cassano Murge, Italy

Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Montescano; 🇮🇹 Montescano, Italy

Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Lumezzane; 🇮🇹 Lumezzane, Italy

Fondazione Salvatore Maugeri - Scientific Institute of Milano; 🇮🇹 Milano, Italy

Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Pavia; 🇮🇹 Pavia, Italy

Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Telese Terme; 🇮🇹 Telese Terme, Italy

Fondazione Salvatore Maugeri - Presidio Major of Torino; 🇮🇹 Torino, Italy

Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Tradate; 🇮🇹 Tradate, Italy

Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno; 🇮🇹 Veruno, Italy