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

January 29, 2014 updated by: Alessandro Mezzani, Fondazione Salvatore Maugeri

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Cassano Murge, Italy, 70020
        • Recruiting
        • Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Cassano Murge
        • Contact:
        • Principal Investigator:
          • Raffaella Catanzaro, MD
      • Lumezzane, Italy, 25066
        • Recruiting
        • Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Lumezzane
        • Contact:
        • Principal Investigator:
          • Francesca Rivadossi, MD
      • Milano, Italy, 20138
        • Recruiting
        • Fondazione Salvatore Maugeri - Scientific Institute of Milano
        • Contact:
        • Principal Investigator:
          • Paolo Totaro, MD
        • Sub-Investigator:
          • Mauro Monelli, MD
      • Montescano, Italy, 27040
        • Recruiting
        • Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Montescano
        • Contact:
        • Principal Investigator:
          • Egidio Traversi, MD
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Pavia
        • Contact:
        • Principal Investigator:
          • Alessandra Gualco, MD
      • Telese Terme, Italy, 82037
        • Recruiting
        • Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Telese Terme
        • Contact:
        • Principal Investigator:
          • Francesco Cacciatore, MD
      • Torino, Italy, 10124
        • Recruiting
        • Fondazione Salvatore Maugeri - Presidio Major of Torino
        • Contact:
        • Principal Investigator:
          • Franco Tarrogenta, MD
      • Tradate, Italy, 21049
        • Recruiting
        • Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Tradate
        • Contact:
        • Principal Investigator:
          • Daniela Guzzetti, MD
      • Veruno, Italy, 28010
        • Recruiting
        • Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno
        • Contact:
        • Principal Investigator:
          • Alessandro Mezzani, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Aerobic exercise training
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.
ACTIVE_COMPARATOR: Standard physical therapy
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distance walked at 6-min walking test
Time Frame: 12 days of intervention
Change from baseline in distance walked at 6-min walking test
12 days of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aerobic exercise training safety and tolerability
Time Frame: 12 days of treatment
Number of participants with serious/non-serious adverse events and completing/not completing the study protocol
12 days of treatment
Patient-reported dyspnea, evaluated by a 7-point Likert scale
Time Frame: 12 days of intervention
Change from baseline in patient-reported dyspnea on a 7-point Likert scale
12 days of intervention
Levels of lymphocyte G protein-coupled receptor kinase-2
Time Frame: 12 days of intervention
Change from baseline in lymphocyte G protein-coupled receptor kinase-2 levels
12 days of intervention
Levels of circulating inflammatory and angiogenetic markers (TNF-alfa, Interleukin-6, Angiopoietin 2 and VEGF)
Time Frame: 12 days of intervention
Change from baseline in circulating inflammatory and angiogenetic markers (TNF-alfa, Interleukin-6, Angiopoietin 2 and VEGF) levels
12 days of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Salvatore Maugeri

Investigators

  • Study Chair: Pantaleo Giannuzzi, MD, Fondazione Salvatore Maugeri - Scientific Institute of Veruno
  • Principal Investigator: Alessandro Mezzani, MD, Fondazione Salvatore Maugeri - Scientific Institute of Veruno

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ANTICIPATED)

June 1, 2015

Study Completion (ANTICIPATED)

September 1, 2015

Study Registration Dates

First Submitted

January 29, 2014

First Submitted That Met QC Criteria

January 29, 2014

First Posted (ESTIMATE)

January 31, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 31, 2014

Last Update Submitted That Met QC Criteria

January 29, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEC 877

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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