Chronic Heart FailureNCT02087670
Natriuretic Brain Pro-peptid Changes in Patients With Chronic Heart Failure Within a Cardiac Rehabilitation Program
A study testing exercise protocol no supervised in people with Chronic Heart Failure, run by Grupo Rehabilitacion en Salud at 1 site in Colombia.
Trial summary
Evaluate pro-BNP levels, oxygen consumption, functional class, and quality of life in patients with chronic heart failure after participating in an exercise program and compare them baseline and 2 months, with another group who underwent an educational program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- exercise protocol no supervised
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteColombia
- Study dates
- Mar 2005to Jan 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients older than 18 years, diagnosed with heart failure (NYHA) II-IV for more than six months
Who cannot join
- patients with NYHA functional class I, who had attended a cardiac rehabilitation program previously, patients with decompensated diabetes mellitus, hypertension difficult to control, ischemic heart disease in the last month, prior pulmonary embolism, chronic obstructive pulmonary disease, restrictive lung disease , aortic stenosis, new episode of atrial fibrillation and musculoskeletal diseases that limit the performance of physical activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Natriuretic Brain Pro-peptid (Pro-BNP)Changes in Patients With Chronic Heart Failure Enroled in a Controlled, Supervised Exercise Protocol Within a Cardiac Rehabilitation Program
Evaluate pro-BNP levels, oxygen consumption, functional class, and quality of life in patients with chronic heart failure after participating in an exercise program and compare them baseline and 2 months, with another group who underwent an educational program.
Read the detailed description
Clinical controlled trial with a double blinded with a aleatory number sequence as the randomization method, patients will be assigned to one of two groups, intervention program (supervises exercise program) and control group (community based exercise)
- Conditions
- Chronic Heart Failure
- Being tested
- controlled, supervised exercise protocol, exercise protocol no supervised
- Keywords
- chronic heart failure, cardiac rehabilitation, exercise, Natriuretic Brain Pro-peptid
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
controlled, supervised exercise protocolOther
exercise program within a cardiac rehabilitation program
exercise protocol no supervisedOther
Exercise program at the community
| Study group | Role | What they receive |
|---|---|---|
| controlled, supervised exercise protocol | Active comparator | controlled, supervised exercise protocol within a cardiac rehabilitation program Receives: Other: controlled, supervised exercise protocol |
| community based exercise | Placebo comparator | educational program and not supervises exercise program Receives: Other: exercise protocol no supervised |
What is being measured
The primary outcome is the main question the study is designed to answer.
Natriuretic Brain Pro-peptid
Measured: 8 weeks
Secondary outcomes (1)
Oxygen Consumption
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startMar 2005
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Rehabilitacion en Salud
- Sponsor type
- Research network
- Collaborators
- Clinica Las Americas
- Responsible party
- Principal investigator, Jesus Alberto Plata Contreras, Grupo Rehabilitacion en Salud
- Investigators
- Jesus Alberto Plata Contreras, physiatrist, Principal investigator, Rehabilitation in health research group. Universidad de AntioquiaAna Milena García Montoya, Resident, Study chair, Universidad de Antioquia,Rehabilitation in health research groupSigifredo Ospina, Doctor, Principal investigator, Hospital Universitario San Vicente FundaciónLuz Helena Lugo Agudelo, physiatrist, Principal investigator, Universidad de Antioquia, Rehabilitation in health research group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087670
- Sponsor's protocol ID
- GrupoRS0002
- Status last verified
- Feb 2016
- First submitted
- 12 Mar 2014
- Last updated
- 10 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natriuretic Brain Pro-peptid (Pro-BNP)Changes in Patients With Chronic Heart Failure Enroled in a Controlled, Supervised Exercise Protocol Within a Cardiac Rehabilitation Program
- ClinicalTrials.gov ID
- NCT02087670
- Acronym / sponsor ID
- GrupoRS0002
- Conditions
- Chronic Heart Failure
- Keywords
- chronic heart failure, cardiac rehabilitation, exercise, Natriuretic Brain Pro-peptid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Grupo Rehabilitacion en SaludResearch network
- Collaborators
- Clinica Las Americas
- Study start
- Mar 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Posted 7 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate pro-BNP levels, oxygen consumption, functional class, and quality of life in patients with chronic heart failure after participating in an exercise program and compare them baseline and 2 months, with another group who underwent an educational program.
Detailed description
Clinical controlled trial with a double blinded with a aleatory number sequence as the randomization method, patients will be assigned to one of two groups, intervention program (supervises exercise program) and control group (community based exercise)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| controlled, supervised exercise protocol | Active comparator | Other: controlled, supervised exercise protocolcontrolled, supervised exercise protocol within a cardiac rehabilitation program |
| community based exercise | Placebo comparator | Other: exercise protocol no supervisededucational program and not supervises exercise program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients older than 18 years, diagnosed with heart failure (NYHA) II-IV for more than six months
Key exclusion criteria (1 listed)
- patients with NYHA functional class I, who had attended a cardiac rehabilitation program previously, patients with decompensated diabetes mellitus, hypertension difficult to control, ischemic heart disease in the last month, prior pulmonary embolism, chronic obstructive pulmonary disease, restrictive lung disease , aortic stenosis, new episode of atrial fibrillation and musculoskeletal diseases that limit the performance of physical activity
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 |
|---|---|---|
| controlled, supervised exercise protocolexercise program within a cardiac rehabilitation program | Other | controlled, supervised exercise protocol |
| exercise protocol no supervisedExercise program at the community | Other | community based exercise |
Primary outcome
Natriuretic Brain Pro-peptid
Time frame: 8 weeks
1 secondary outcome
Oxygen Consumption
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jesus Alberto Plata Contreras, physiatrist principal investigator
Rehabilitation in health research group. Universidad de Antioquia
Ana Milena García Montoya, Resident study chair
Universidad de Antioquia,Rehabilitation in health research group
Sigifredo Ospina, Doctor principal investigator
Hospital Universitario San Vicente Fundación
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise protocol no supervised in people with Chronic Heart Failure, run by Grupo Rehabilitacion en Salud at 1 site in Colombia.
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 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. 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. 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?
Yes. Results are posted in the registry (first posted 7 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Natriuretic Brain Pro-peptid (time frame: 8 weeks). 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 10 Mar 2016.