Evaluation of Clinical and Genetic Modifiers of Long-term... | NCT03461107

Studies
Evaluation of Clinical and Genetic Modifiers of Long-term Survival in Heart Failure

NCT03461107

Sponsor

Tongji Hospital

Status

Unknown status

Last Update Posted

Apr 10, 2019Actual

Enrollment

2,500Estimated

Phase

Not provided

Conditions

Heart Failure

Interventions

No intervention

Countries

China

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

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 18, 2016Actual

Primary Completion Date

Dec 31, 2019Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Mar 5, 2018

First Submission Date that Met QC Criteria

Mar 5, 2018

First Posted Date

Mar 9, 2018Actual

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

Apr 8, 2019

Last Update Posted Date

Apr 10, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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 evaluate the beta-adrenergic receptor gene polymorphisms in the long-term effects of beta-blockade in patients with chronic heart failure.

Detailed Description

Not provided

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

2,500Estimated

Label	Type	Description	Intervention Names
patients with heart failure			Other: No intervention

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other		patients with heart failure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiovascular death		up to 24 months
Heart transplantation		up to 24 months

Secondary Outcomes

Measure	Description	Time Frame
All cause death		up to 24 months
Heart failure recuring		up to 24 months
Readmission because of cardiovascular diseases

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age or older;
Patients are required to have chronic heart failure (NYHA II-IV) with a left ventricular ejection fraction lower than 40%;
Patients are voluntary and signed informed consent.

Exclusion Criteria:

Pregnant women or plan to;
Participate in any drug clinical trials within 3 months;
Serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressive lower limbs or deaf patients);
Previous history of cancer or tumor, or pathological examination confirmed precancerous lesions;
Patients refused to comply with the requirements of this study to complete the research work;
According to the researchers, patients can not complete the study or not to comply with the requirements of this study (because of the reasons for the management or other reasons).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

2500 outpatients or hospitalized patients with chronic heart failure will be enrolled in this study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Li Ni, doctor	Contact	86-27-83663280		nili@tjh.tjmu.edu.cn

Overall Officials

Name	Affiliation	Role
Dao Wen Wang, doctor	Tongji Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tongji Hospital	Recruiting	Wuhan	Hubei	430030	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37871528	Derived	Zhao C, Jiang X, Peng L, Zhang Y, Li H, Zhang Q, Wang Y, Yang F, Wu J, Wen Z, He Z, Shen J, Chen C, Wang DW. Glimepiride, a novel soluble epoxide hydrolase inhibitor, protects against heart failure via increasing epoxyeicosatrienoic acids. J Mol Cell Cardiol. 2023 Dec;185:13-25. doi: 10.1016/j.yjmcc.2023.10.009. Epub 2023 Oct 21.
37291118

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases