Heart FailureNCT02782572
Safety of Aerobic Exercise in Acute Heart Failure
A study testing Exercise in people with Heart Failure and Acute Heart Failure, run by Instituto Dante Pazzanese de Cardiologia.
Trial summary
This project deals with exercise in acute heart failure in three different groups (conventional medical treatment; exercise with non-invasive ventilation and exercise with placebo of non-invasive ventilation). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Acute Heart Failure
- What is being tested?
- Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Dec 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- established diagnosis of acute HF; previous Doppler echocardiography with left ventricle ejection fraction (LVEF) <30%, and NYHA Class IV.
Who cannot join
- unstable angina, complex cardiac arrhythmias, pacemaker, cardiac resynchronization therapy or left ventricle assist device, myocardial infarction within the previous 12 months, oxygen saturation by pulse oximetry (SpO2) at rest < 88% without oxygen supplementation, acute pulmonary edema with clinical indications for mechanical ventilation
About this study
Official title: Safety and Efficacy of Exercise Training in Patients With Acute Heart Failure: a Pilot Study
This project deals with exercise in acute heart failure in three different groups (conventional medical treatment; exercise with non-invasive ventilation and exercise with placebo of non-invasive ventilation).
Read the detailed description
All of the subjects performed an individualized clinical evaluation right after hospital admission on day 1 (D1) by the cardiologist and physiotherapis involved in the study. Pulmonary function tests (spirometry), blood sample (brain natriuretic peptide [NT-proBNP] and high sensitive C-reactive protein [hs-CRP]), six-minute walk test (6MWT), and maximal inspiratory pressure (MIP) test were performed.
After the clinical tests were performed, the patients were randomized into three groups, and all received standard medical treatment.
The control group (CTL) received medical treatment and did not perform aerobic exercise training; the ET+NIV group performed aerobic exercise training associated with NIV once a day, for 8 consecutive days; and the ET+Sham group performed aerobic exercise with placebo NIV once a day, for 8 consecutive days. The ET+NIV and ET+Sham groups also received medical treatment.
After eight consecutive days, all of the patients underwent a new clinical evaluation (D10). After D10, all of the patients continued to receive only conventional treatment, and they were followed up for main outcomes (hospital discharge, worsening HF, or death). Worsening HF was considered when a patient needed to be transferred to the intensive care unit.
- Conditions
- Heart Failure, Acute Heart Failure
- Being tested
- Exercise
- Keywords
- Exercise, Cardiac Rehabilitation, Non-invasive ventilation
- Medical subject headings
- Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Conventional medical treatment, Non-invasive ventilation
Exercise in acute heart failure in three different groups (conventional medical treatment; exercise with non-invasive ventilation and exercise with placebo of non-invasive ventilation).
| Study group | Role | What they receive |
|---|---|---|
| Exercise with Non-invasive ventilation | Experimental | Patients with acute haert failure who performed aerobic exercise with non-invasive ventilation. This group also received conventional medical treatment. Receives: Other: Exercise |
| Exercise | Sham comparator | Patients with acute haert failure who performed aerobic exercise with placebo of non-invasive ventilation. This group also received conventional medical treatment. Receives: Other: Exercise |
| Control | Other | Patients who receiveid only conventional medical treatment and not performed exercise during protocol. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy of exercise in acute heart failure
After exercise protocol, all of the patients continued to receive only conventional treatment, and they were followed up for main outcomes (hospital discharge, worsening HF, or death). Worsening HF was considered when a patient needed to be transferred to the intensive care unit.
Measured: Patients were followed up until hospital discharge. up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study startJul 2010
- Primary completionSep 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Dante Pazzanese de Cardiologia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mayron Faria de Oliveira, Instituto Dante Pazzanese de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782572
- Sponsor's protocol ID
- 3646
- Status last verified
- Jul 2011
- First submitted
- 19 May 2016
- Last updated
- 25 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Exercise Training in Patients With Acute Heart Failure: a Pilot Study
- ClinicalTrials.gov ID
- NCT02782572
- Acronym / sponsor ID
- 3646
- Conditions
- Heart Failure, Acute Heart Failure
- Keywords
- Exercise, Cardiac Rehabilitation, Non-invasive ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Instituto Dante Pazzanese de CardiologiaUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 May 2016 (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.
This project deals with exercise in acute heart failure in three different groups (conventional medical treatment; exercise with non-invasive ventilation and exercise with placebo of non-invasive ventilation).
Detailed description
All of the subjects performed an individualized clinical evaluation right after hospital admission on day 1 (D1) by the cardiologist and physiotherapis involved in the study. Pulmonary function tests (spirometry), blood sample (brain natriuretic peptide [NT-proBNP] and high sensitive C-reactive protein [hs-CRP]), six-minute walk test (6MWT), and maximal inspiratory pressure (MIP) test were performed.
After the clinical tests were performed, the patients were randomized into three groups, and all received standard medical treatment.
The control group (CTL) received medical treatment and did not perform aerobic exercise training; the ET+NIV group performed aerobic exercise training associated with NIV once a day, for 8 consecutive days; and the ET+Sham group performed aerobic exercise with placebo NIV once a day, for 8 consecutive days. The ET+NIV and ET+Sham groups also received medical treatment.
After eight consecutive days, all of the patients underwent a new clinical evaluation (D10). After D10, all of the patients continued to receive only conventional treatment, and they were followed up for main outcomes (hospital discharge, worsening HF, or death). Worsening HF was considered when a patient needed to be transferred to the intensive care unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise with Non-invasive ventilation | Experimental | Other: ExercisePatients with acute haert failure who performed aerobic exercise with non-invasive ventilation. This group also received conventional medical treatment. |
| Exercise | Sham comparator | Other: ExercisePatients with acute haert failure who performed aerobic exercise with placebo of non-invasive ventilation. This group also received conventional medical treatment. |
| Control | Other | Other: ExercisePatients who receiveid only conventional medical treatment and not performed exercise during protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- established diagnosis of acute HF; previous Doppler echocardiography with left ventricle ejection fraction (LVEF) <30%, and NYHA Class IV.
Key exclusion criteria (1 listed)
- unstable angina, complex cardiac arrhythmias, pacemaker, cardiac resynchronization therapy or left ventricle assist device, myocardial infarction within the previous 12 months, oxygen saturation by pulse oximetry (SpO2) at rest < 88% without oxygen supplementation, acute pulmonary edema with clinical indications for mechanical ventilation
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 |
|---|---|---|
| ExerciseAlso: Conventional medical treatment, Non-invasive ventilationExercise in acute heart failure in three different groups (conventional medical treatment; exercise with non-invasive ventilation and exercise with placebo of non-invasive ventilation). | Other | Control, Exercise, Exercise with Non-invasive ventilation |
Primary outcome
Safety and efficacy of exercise in acute heart failure
Time frame: Patients were followed up until hospital discharge. up to 60 days
After exercise protocol, all of the patients continued to receive only conventional treatment, and they were followed up for main outcomes (hospital discharge, worsening HF, or death). Worsening HF was considered when a patient needed to be transferred to the intensive care unit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Heart Failure and Acute Heart Failure, run by Instituto Dante Pazzanese de Cardiologia.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 25 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and efficacy of exercise in acute heart failure (time frame: Patients were followed up until hospital discharge. up to 60 days). 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 25 May 2016.