Heart FailureNCT02047409
Prognostic Value of Sympathetic Modulation in Patients With Heart Failure
An observational study of Heart Failure, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether oscillatory pattern of sympathetic nerve activity muscle is an efficient index for the prognosis of patients with heart failure. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Heart Failure
- How many people
- 160 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2013to Oct 2016
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The sample consisted of patients with heart failure in clinical follow up at the Heart Institute (InCor), University of São Paulo, School of Medicine.
Who may be able to join
- Patients with systolic heart failure and New York Heart Association (NYHA)
- Ischemic, hypertensive, or idiopathic etiology
- Left ventricular ejection fraction less than 40%
Who cannot join
- Neuromuscular, Orthopedic, Neurologic and Pulmonary Diseases
- Renal failure
- Diabetes mellitus type II
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Heart Institute (InCor), University of Sao Paulo, School of Medicine.
São Paulo, São Paulo, 05403-900
Edgar Toschi Dias, PhD, 55 11 2661-5099, edgar.dias@incor.usp.br
Maria Urbana P B Rondon, PhD, 55 11 3091-8784, urbana@usp.br
About this study
Official title: Prognostic Value of Oscillatory Pattern of Sympathetic Nerve Activity Muscle in Patients With Heart Failure
The purpose of this study is to determine whether oscillatory pattern of sympathetic nerve activity muscle is an efficient index for the prognosis of patients with heart failure.
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral autonomic control
Evaluate if the reduction in the oscillatory pattern of muscle sympathetic nerve activity is associated with morbidity and mortality in patients with heart failure in a clinical follow-up 12 months
Measured: 12 months
Secondary outcomes (4)
Arterial baroreflex control
Measured: 12 months
Blood inflammatory markers
Measured: 12 months
Cardiac and peripheral autonomic control
Measured: 12 months
Functional Capacity
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startOct 2013
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
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.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- InCor Heart Institute, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047409
- Sponsor's protocol ID
- EDT-13001-PD
- Other IDs
- 2013/07651-7, 2010/50048-1
- Status last verified
- Sep 2015
- First submitted
- 24 Jan 2014
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Oscillatory Pattern of Sympathetic Nerve Activity Muscle in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT02047409
- Acronym / sponsor ID
- EDT-13001-PD
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- InCor Heart Institute, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Oct 2013
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 28 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 determine whether oscillatory pattern of sympathetic nerve activity muscle is an efficient index for the prognosis of patients with heart failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The sample consisted of patients with heart failure in clinical follow up at the Heart Institute (InCor), University of São Paulo, School of Medicine.
Key inclusion criteria (3 listed)
- Patients with systolic heart failure and New York Heart Association (NYHA)
- Ischemic, hypertensive, or idiopathic etiology
- Left ventricular ejection fraction less than 40%
Key exclusion criteria (3 listed)
- Neuromuscular, Orthopedic, Neurologic and Pulmonary Diseases
- Renal failure
- Diabetes mellitus type II
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peripheral autonomic control
Time frame: 12 months
Evaluate if the reduction in the oscillatory pattern of muscle sympathetic nerve activity is associated with morbidity and mortality in patients with heart failure in a clinical follow-up 12 months
4 secondary outcomes
Arterial baroreflex control
Time frame: 12 months
Blood inflammatory markers
Time frame: 12 months
Cardiac and peripheral autonomic control
Time frame: 12 months
Functional Capacity
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 3 inclusion and 3 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 22 Sep 2015. 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 Brazil. 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 Edgar Toschi Dias, PhD (55 11 2661-5099, edgar.dias@incor.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral autonomic control (time frame: 12 months). 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 22 Sep 2015.