Novel Risk Factors of Atrial Fibrillation in Patients Wit... | NCT02655185

Studies
Novel Risk Factors of Atrial Fibrillation in Patients With Chronic Heart Failure

NCT02655185

Sponsor

Yangzhou No.1 People's Hospital

Status

Unknown status

Last Update Posted

Jan 13, 2016Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Heart Failure

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2016

Primary Completion Date

Jul 2018Estimated

Completion Date

Jul 2019Estimated

First Submitted Date

Jan 10, 2016

First Submission Date that Met QC Criteria

Jan 11, 2016

First Posted Date

Jan 13, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2016

Last Update Posted Date

Jan 13, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Liu Chen, associate chief physician, Yangzhou No.1 People's HospitalPrincipal Investigator

Lead Sponsor

Yangzhou No.1 People's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Label	Type	Description	Intervention Names
Heart failure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with newly emerging atrial fibrillation as assessed by electrocardiogram		three years

Secondary Outcomes

Measure	Description	Time Frame
Cardiovascular mortality		three years
Worsing heart failure assessed by decreased NYHA class and left ventricular ejection fraction		three years
rate of rehospitalization

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of chronic heart failure

Exclusion Criteria:

Use of statins

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

In-hospital patients with a diagnosis of chronic heart failure will be recruited at Yangzhou No.1 people's hospital, China.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chen - Liu, MD	Contact	+86-13301457671		liuchen007@163.com

Overall Officials

Name	Affiliation	Role
Chen - Liu, MD	Yangzhou No.1 People's Hospital	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001145	Arrhythmias, Cardiac
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided