Early-start Exercise Training in Subacute Heart Failure

Chronic Heart Failure Clinical Trial

— RE-START  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02051985
• Other study ID #: CEC 877
• Status: Recruiting
• Phase: N/A
• First received: January 29, 2014
• Last updated: January 29, 2014
• Start date: October 2013
• Est. completion date: September 2015

Study information

• Verified date: January 2014
• Source: Fondazione Salvatore Maugeri
• Contact: Alessandro Mezzani, MD
• Phone: +39-3403119299
• Email: alessandro.mezzani[@]fsm.it
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Decompensation
• Heart Failure

Intervention

Other:
• Aerobic exercise training
Days 1-2: active assisted mobilization (2 sessions/day, each 30 minutes duration). Days 3-4: as days 1-2 + unloaded bedside cycle ergometer (3 sessions/day, each 5-6 minutes duration). Days 5-6: as days 1-2 + bedside cycle ergometer at 10 W (3 sessions/day, each 15-20 minutes duration). Days 7-12: as days 1-2 + bedside cycle ergometer at 10-20 W (3 sessions/day, each 15-20 minutes duration). In addition, when possible according to their clinical conditions, patients will undergo one assisted ambulation session of 15-20 minutes per day.
• Standard physical therapy
Days 1-2: active assisted mobilization (2 sessions/day, each 30 minutes duration). Days 3-12: active assisted mobilization (1 session/day, 30 minutes duration). In addition, when possible according to their clinical conditions, patients will undergo one assisted ambulation session of 15-20 minutes per day.

Locations

Country	Name	City	State
Italy	Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Cassano Murge	Cassano Murge
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 Montescano	Montescano
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

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Salvatore Maugeri

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance walked at 6-min walking test	Change from baseline in distance walked at 6-min walking test	12 days of intervention	No
Secondary	Aerobic exercise training safety and tolerability	Number of participants with serious/non-serious adverse events and completing/not completing the study protocol	12 days of treatment	Yes
Secondary	Patient-reported dyspnea, evaluated by a 7-point Likert scale	Change from baseline in patient-reported dyspnea on a 7-point Likert scale	12 days of intervention	No
Secondary	Levels of lymphocyte G protein-coupled receptor kinase-2	Change from baseline in lymphocyte G protein-coupled receptor kinase-2 levels	12 days of intervention	No
Secondary	Levels of circulating inflammatory and angiogenetic markers (TNF-alfa, Interleukin-6, Angiopoietin 2 and VEGF)	Change from baseline in circulating inflammatory and angiogenetic markers (TNF-alfa, Interleukin-6, Angiopoietin 2 and VEGF) levels	12 days of intervention	No

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