Chronic Heart FailureRE-STARTNCT02051985
Early-start Exercise Training in Subacute Heart Failure
A study testing Aerobic exercise training and Standard physical therapy in people with Chronic Heart Failure and Heart Decompensation, run by Fondazione Salvatore Maugeri at 9 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Heart Failure, Heart Decompensation
- What is being tested?
- Aerobic exercise training and Standard physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 9 sitesItaly
- Study dates
- Oct 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Italy9 sites, 9 recruiting
- Recruiting
Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Cassano Murge
Cassano Murge, 70020
Raffaella Catanzaro, MD, raffaella.catanzaro@fsm.it
Raffaella Catanzaro, MD
- Recruiting
Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Lumezzane
Lumezzane, 25066
Francesca Rivadossi, MD, francesca.rivadossi@fsm.it
Francesca Rivadossi, MD
- Recruiting
Fondazione Salvatore Maugeri - Scientific Institute of Milano
Milan, 20138
Paolo Totaro, MD, paolo.totaro@fsm.it
MD
- Recruiting
Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Montescano
Montescano, 27040
Egidio Traversi, MD, egidio.traversi@fsm.it
Egidio Traversi, MD
- Recruiting
Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Pavia
Pavia, 27100
Alessandra Gualco, MD, alessandra.gualco@fsm.it
Alessandra Gualco, MD
- Recruiting
Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Telese Terme
Telese Terme, 82037
Francesco Cacciatore, MD, francesco.cacciatore@fsm.it
Francesco Cacciatore, MD
- Recruiting
Fondazione Salvatore Maugeri - Presidio Major of Torino
Torino, 10124
Franco Tarrogenta, MD, franco.tarrogenta@fsm.it
Franco Tarrogenta, MD
- Recruiting
Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Tradate
Tradate, 21049
Daniela Guzzetti, MD, daniela.guzzetti@fsm.it
Daniela Guzzetti, MD
- Recruiting
Fondazione Salvatore Maugeri, IRCCS - Scientific Institute of Veruno
Veruno, 28010
Alessandro Mezzani, MD, 3403119299, alessandro.mezzani@fsm.it
Alessandro Mezzani, MD
About this study
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.
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.
Read the 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.
- Conditions
- Chronic Heart Failure, Heart Decompensation
- Being tested
- Aerobic exercise training, Standard physical therapy
- Keywords
- Chronic heart failure, Heart decompensation, Aerobic exercise training, Functional capacity, Dyspnea, Beta-adrenergic receptor signaling
- Medical subject headings
- Heart Failure, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise trainingOther
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 therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise training | Experimental | Not described Receives: Other: Aerobic exercise training |
| Standard physical therapy | Active comparator | Not described Receives: Other: Standard physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance walked at 6-min walking test
Change from baseline in distance walked at 6-min walking test
Measured: 12 days of intervention
Secondary outcomes (4)
Aerobic exercise training safety and tolerability
Number of participants with serious/non-serious adverse events and completing/not completing the study protocol
Measured: 12 days of treatment
Patient-reported dyspnea, evaluated by a 7-point Likert scale
Change from baseline in patient-reported dyspnea on a 7-point Likert scale
Measured: 12 days of intervention
Levels of lymphocyte G protein-coupled receptor kinase-2
Change from baseline in lymphocyte G protein-coupled receptor kinase-2 levels
Measured: 12 days of intervention
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
Measured: 12 days of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startOct 2013
- Primary completionJun 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Salvatore Maugeri
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Mezzani, Fondazione Salvatore Maugeri
- Investigators
- Pantaleo Giannuzzi, MD, Study chair, Fondazione Salvatore Maugeri - Scientific Institute of VerunoAlessandro Mezzani, MD, Principal investigator, Fondazione Salvatore Maugeri - Scientific Institute of Veruno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051985
- Sponsor's protocol ID
- CEC 877
- Acronym
- RE-START
- Status last verified
- Jan 2014
- First submitted
- 29 Jan 2014
- Last updated
- 31 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02051985
- Acronym / sponsor ID
- RE-START / CEC 877
- Conditions
- Chronic Heart Failure, Heart Decompensation
- Keywords
- Chronic heart failure, Heart decompensation, Aerobic exercise training, Functional capacity, Dyspnea, Beta-adrenergic receptor signaling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione Salvatore MaugeriUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 31 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise training | Experimental | Other: Aerobic exercise training |
| Standard physical therapy | Active comparator | Other: Standard physical therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise trainingDays 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. | Other | Aerobic exercise training |
| Standard physical therapyDays 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. | Other | Standard physical therapy |
Primary outcome
Distance walked at 6-min walking test
Time frame: 12 days of intervention
Change from baseline in distance walked at 6-min walking test
4 secondary outcomes
Aerobic exercise training safety and tolerability
Time frame: 12 days of treatment
Patient-reported dyspnea, evaluated by a 7-point Likert scale
Time frame: 12 days of intervention
Levels of lymphocyte G protein-coupled receptor kinase-2
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2014.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pantaleo Giannuzzi, MD study chair
Fondazione Salvatore Maugeri - Scientific Institute of Veruno
Alessandro Mezzani, MD principal investigator
Fondazione Salvatore Maugeri - Scientific Institute of Veruno
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise training and Standard physical therapy in people with Chronic Heart Failure and Heart Decompensation, run by Fondazione Salvatore Maugeri at 9 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Mezzani, MD (+39-3403119299, alessandro.mezzani@fsm.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance walked at 6-min walking test (time frame: 12 days of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2014; AzTrials last refreshed its copy on 27 Oct 2026.