Clinical trial NCT02051985: Early-start Exercise Training in Subacute Heart Failure
Official title: Early-start Exercise Training After Acute Hemodynamic Decompensation in Patients With Chronic Heart Failure. A Multicenter, Randomized, Controlled Trial on Feasibility and Impact on Functional Capacity, Symptoms and Neurohumoral Activation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Heart Failure
Heart Decompensation
Keywords: Chronic heart failure
Heart decompensation
Aerobic exercise training
Functional capacity
Dyspnea
Beta-adrenergic receptor signaling
Lead sponsor: Fondazione Salvatore Maugeri
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Distance walked at 6-min walking test
timeFrame: 12 days of intervention
Secondary outcomes:
measure: Aerobic exercise training safety and tolerability
timeFrame: 12 days of treatment
measure: Patient-reported dyspnea, evaluated by a 7-point Likert scale
timeFrame: 12 days of intervention
measure: Levels of lymphocyte G protein-coupled receptor kinase-2
timeFrame: 12 days of intervention
measure: Levels of circulating inflammatory and angiogenetic markers (TNF-alfa, Interleukin-6, Angiopoietin 2 and VEGF)
timeFrame: 12 days of intervention
Other outcomes:
Locations:
city: Cassano Murge
country: Italy
facility: Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Cassano Murge
city: Lumezzane
country: Italy
facility: Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Lumezzane
city: Milano
country: Italy
facility: Fondazione Salvatore Maugeri - Scientific Institute of Milano
city: Montescano
country: Italy
facility: Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Montescano
city: Pavia
country: Italy
facility: Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Pavia
city: Telese Terme
country: Italy
facility: Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Telese Terme
city: Torino
country: Italy
facility: Fondazione Salvatore Maugeri - Presidio Major of Torino
city: Tradate
country: Italy
facility: Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Tradate
city: Veruno
country: Italy
facility: Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno
Study officials:
affiliation: Fondazione Salvatore Maugeri - Scientific Institute of Veruno
name: Pantaleo Giannuzzi, MD
role: STUDY_CHAIR
affiliation: Fondazione Salvatore Maugeri - Scientific Institute of Veruno
name: Alessandro Mezzani, MD
role: PRINCIPAL_INVESTIGATOR
References: