Early-start Exercise Training in Subacute Heart Failure (RE-START)

Fondazione Salvatore Maugeri

Status: Unknown

Conditions: Heart Decompensation; Chronic Heart Failure

Treatments: Other: Standard physical therapy; Other: Aerobic exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT02051985

CEC 877

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Aerobic exercise training

Experimental group

Treatment:

Other: Aerobic exercise training

Standard physical therapy

Active Comparator group

Treatment:

Other: Standard physical therapy