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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02051985
Other study ID # CEC 877
Secondary ID
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


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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