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

Primary Purpose

Chronic Heart Failure, Heart Decompensation

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Aerobic exercise training
Standard physical therapy
Sponsored by
Fondazione Salvatore Maugeri
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring Chronic heart failure, Heart decompensation, Aerobic exercise training, Functional capacity, Dyspnea, Beta-adrenergic receptor signaling

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Cassano MurgeRecruiting
  • Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of LumezzaneRecruiting
  • Fondazione Salvatore Maugeri - Scientific Institute of MilanoRecruiting
  • Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of MontescanoRecruiting
  • Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of PaviaRecruiting
  • Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Telese TermeRecruiting
  • Fondazione Salvatore Maugeri - Presidio Major of TorinoRecruiting
  • Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of TradateRecruiting
  • Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of VerunoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aerobic exercise training

Standard physical therapy

Arm Description

Outcomes

Primary Outcome Measures

Distance walked at 6-min walking test
Change from baseline in distance walked at 6-min walking test

Secondary Outcome Measures

Aerobic exercise training safety and tolerability
Number of participants with serious/non-serious adverse events and completing/not completing the study protocol
Patient-reported dyspnea, evaluated by a 7-point Likert scale
Change from baseline in patient-reported dyspnea on a 7-point Likert scale
Levels of lymphocyte G protein-coupled receptor kinase-2
Change from baseline in lymphocyte G protein-coupled receptor kinase-2 levels
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

Full Information

First Posted
January 29, 2014
Last Updated
January 29, 2014
Sponsor
Fondazione Salvatore Maugeri
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1. Study Identification

Unique Protocol Identification Number
NCT02051985
Brief Title
Early-start Exercise Training in Subacute Heart Failure
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Salvatore Maugeri

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure, Heart Decompensation
Keywords
Chronic heart failure, Heart decompensation, Aerobic exercise training, Functional capacity, Dyspnea, Beta-adrenergic receptor signaling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobic exercise training
Arm Type
Experimental
Arm Title
Standard physical therapy
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Aerobic exercise training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard physical therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Distance walked at 6-min walking test
Description
Change from baseline in distance walked at 6-min walking test
Time Frame
12 days of intervention
Secondary Outcome Measure Information:
Title
Aerobic exercise training safety and tolerability
Description
Number of participants with serious/non-serious adverse events and completing/not completing the study protocol
Time Frame
12 days of treatment
Title
Patient-reported dyspnea, evaluated by a 7-point Likert scale
Description
Change from baseline in patient-reported dyspnea on a 7-point Likert scale
Time Frame
12 days of intervention
Title
Levels of lymphocyte G protein-coupled receptor kinase-2
Description
Change from baseline in lymphocyte G protein-coupled receptor kinase-2 levels
Time Frame
12 days of intervention
Title
Levels of circulating inflammatory and angiogenetic markers (TNF-alfa, Interleukin-6, Angiopoietin 2 and VEGF)
Description
Change from baseline in circulating inflammatory and angiogenetic markers (TNF-alfa, Interleukin-6, Angiopoietin 2 and VEGF) levels
Time Frame
12 days of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandro Mezzani, MD
Phone
+39-3403119299
Email
alessandro.mezzani@fsm.it
First Name & Middle Initial & Last Name or Official Title & Degree
Pantaleo Giannuzzi, MD
Phone
+39-0322-884812
Email
pantaleo.giannuzzi@fsm.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pantaleo Giannuzzi, MD
Organizational Affiliation
Fondazione Salvatore Maugeri - Scientific Institute of Veruno
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alessandro Mezzani, MD
Organizational Affiliation
Fondazione Salvatore Maugeri - Scientific Institute of Veruno
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Cassano Murge
City
Cassano Murge
ZIP/Postal Code
70020
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raffaella Catanzaro, MD
Email
raffaella.catanzaro@fsm.it
First Name & Middle Initial & Last Name & Degree
Raffaella Catanzaro, MD
Facility Name
Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Lumezzane
City
Lumezzane
ZIP/Postal Code
25066
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca Rivadossi, MD
Email
francesca.rivadossi@fsm.it
First Name & Middle Initial & Last Name & Degree
Francesca Rivadossi, MD
Facility Name
Fondazione Salvatore Maugeri - Scientific Institute of Milano
City
Milano
ZIP/Postal Code
20138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Totaro, MD
Email
paolo.totaro@fsm.it
First Name & Middle Initial & Last Name & Degree
MD
First Name & Middle Initial & Last Name & Degree
Paolo Totaro, MD
First Name & Middle Initial & Last Name & Degree
Mauro Monelli, MD
Facility Name
Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Montescano
City
Montescano
ZIP/Postal Code
27040
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Egidio Traversi, MD
Email
egidio.traversi@fsm.it
First Name & Middle Initial & Last Name & Degree
Egidio Traversi, MD
Facility Name
Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Pavia
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandra Gualco, MD
Email
alessandra.gualco@fsm.it
First Name & Middle Initial & Last Name & Degree
Alessandra Gualco, MD
Facility Name
Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Telese Terme
City
Telese Terme
ZIP/Postal Code
82037
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Cacciatore, MD
Email
francesco.cacciatore@fsm.it
First Name & Middle Initial & Last Name & Degree
Francesco Cacciatore, MD
Facility Name
Fondazione Salvatore Maugeri - Presidio Major of Torino
City
Torino
ZIP/Postal Code
10124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franco Tarrogenta, MD
Email
franco.tarrogenta@fsm.it
First Name & Middle Initial & Last Name & Degree
Franco Tarrogenta, MD
Facility Name
Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Tradate
City
Tradate
ZIP/Postal Code
21049
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Guzzetti, MD
Email
daniela.guzzetti@fsm.it
First Name & Middle Initial & Last Name & Degree
Daniela Guzzetti, MD
Facility Name
Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno
City
Veruno
ZIP/Postal Code
28010
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Mezzani, MD
Phone
3403119299
Email
alessandro.mezzani@fsm.it
First Name & Middle Initial & Last Name & Degree
Alessandro Mezzani, MD

12. IPD Sharing Statement

Links:
URL
http://www.fsm.it
Description
Related Info

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Early-start Exercise Training in Subacute Heart Failure

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