Heart FailureNCT02655185
Novel Risk Factors of Atrial Fibrillation in Patients With Chronic Heart Failure
An observational study of Heart Failure, run by Yangzhou No.1 People's Hospital.
Trial summary
The purpose of this study is to determine whether lipid levels are related with incidence of atrial fibrillation in Patients with chronic heart failure. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Heart Failure
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Jul 2019
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In-hospital patients with a diagnosis of chronic heart failure will be recruited at Yangzhou No.1 people's hospital, China.
Who may be able to join
- Clinical diagnosis of chronic heart failure
Who cannot join
- Use of statins
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study to Evaluate Association of Blood Lipid Levels With Atrial Fibrillation Incidence in Patients With Chronic Heart Failure
The purpose of this study is to determine whether lipid levels are related with incidence of atrial fibrillation in Patients with chronic heart failure.
Read the detailed description
Atrial fibrillation (AF) is the most common cardiac arrhythmia in clinical practice. Chronic Heart failure (CHF) has become a major clinical and public health problem. Both AF and CHF often co-exist and complicate each other's administration.Several risk factors have been demonstrated to be associated with the risk of AF in Patients with CHF.
Lopez et al. found that higher levels of low-density lipoprotein cholesterol (LDLc) and total cholesterol were associated with a lower incidence of AF independently of other risk factors from the Atherosclerosis Risk in Communities (ARIC) study.
Thus the purpose of this study is to determine whether lipid levels are related with incidence of atrial fibrillation in Patients with chronic heart failure. This study maybe provide a novel opinion on the prevention of AF in patients with CHF.
- Conditions
- Heart Failure
- Keywords
- Lipids, Atrial Fibrillation, Heart Failure
- Medical subject headings
- Heart Failure, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heart failure | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with newly emerging atrial fibrillation as assessed by electrocardiogram
Measured: three years
Secondary outcomes (3)
Cardiovascular mortality
Measured: three years
Worsing heart failure assessed by decreased NYHA class and left ventricular ejection fraction
Measured: three years
rate of rehospitalization
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2018 (estimated)
- Study completionJul 2019 (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.
- 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yangzhou No.1 People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Chen, Yangzhou No.1 People's Hospital
- Investigators
- Chen - Liu, MD, Principal investigator, Yangzhou No.1 People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655185
- Sponsor's protocol ID
- 2016003
- Status last verified
- Jan 2016
- First submitted
- 10 Jan 2016
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate Association of Blood Lipid Levels With Atrial Fibrillation Incidence in Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT02655185
- Acronym / sponsor ID
- 2016003
- Conditions
- Heart Failure
- Keywords
- Lipids, Atrial Fibrillation, Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Yangzhou No.1 People's HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 13 Jan 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.
The purpose of this study is to determine whether lipid levels are related with incidence of atrial fibrillation in Patients with chronic heart failure.
Detailed description
Atrial fibrillation (AF) is the most common cardiac arrhythmia in clinical practice. Chronic Heart failure (CHF) has become a major clinical and public health problem. Both AF and CHF often co-exist and complicate each other's administration.Several risk factors have been demonstrated to be associated with the risk of AF in Patients with CHF.
Lopez et al. found that higher levels of low-density lipoprotein cholesterol (LDLc) and total cholesterol were associated with a lower incidence of AF independently of other risk factors from the Atherosclerosis Risk in Communities (ARIC) study.
Thus the purpose of this study is to determine whether lipid levels are related with incidence of atrial fibrillation in Patients with chronic heart failure. This study maybe provide a novel opinion on the prevention of AF in patients with CHF.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart failure | – | – |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In-hospital patients with a diagnosis of chronic heart failure will be recruited at Yangzhou No.1 people's hospital, China.
Key inclusion criteria (1 listed)
- Clinical diagnosis of chronic heart failure
Key exclusion criteria (1 listed)
- Use of statins
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
Number of participants with newly emerging atrial fibrillation as assessed by electrocardiogram
Time frame: three years
3 secondary outcomes
Cardiovascular mortality
Time frame: three years
Worsing heart failure assessed by decreased NYHA class and left ventricular ejection fraction
Time frame: three years
rate of rehospitalization
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 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.
Chen - Liu, MD principal investigator
Yangzhou No.1 People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Yangzhou No.1 People's Hospital.
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: status not confirmed, as of the sponsor's last update on 13 Jan 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. 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 Chen - Liu, MD (+86-13301457671, liuchen007@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with newly emerging atrial fibrillation as assessed by electrocardiogram (time frame: three years). 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 13 Jan 2016.