NCT03461107

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

3.7 years

First QC Date

March 5, 2018

Last Update Submit

April 8, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Cardiovascular death

    up to 24 months

  • Heart transplantation

    up to 24 months

Secondary Outcomes (3)

  • All cause death

    up to 24 months

  • Heart failure recuring

    up to 24 months

  • Readmission because of cardiovascular diseases

    up to 24 months

Study Arms (1)

patients with heart failure

Other: No intervention

Interventions

patients with heart failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (7)

  • 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.

  • Zhao Y, Li H, Du H, Yin Z, He M, Fan J, Nie X, Sun Y, Hou H, Dai B, Zhang X, Cai Y, Jin K, Ding N, Wen Z, Chang J, Chen C, Wang DW. A Kaposi's sarcoma-associated herpes virus-encoded microRNA contributes to dilated cardiomyopathy. Signal Transduct Target Ther. 2023 Jun 9;8(1):226. doi: 10.1038/s41392-023-01434-3.

  • Peng L, Song Z, Zhao C, Abuduwufuer K, Wang Y, Wen Z, Ni L, Li C, Yu Y, Zhu Y, Jiang H, Shen J, Jiang X, Chen C, Zhang X, Wang DW. Increased Soluble Epoxide Hydrolase Activity Positively Correlates with Mortality in Heart Failure Patients with Preserved Ejection Fraction: Evidence from Metabolomics. Phenomics. 2022 Oct 27;3(1):34-49. doi: 10.1007/s43657-022-00069-8. eCollection 2023 Feb.

  • Wei H, Zhao M, Wu J, Li C, Huang M, Gao J, Zhang Q, Ji L, Wang Y, Zhao C, Dong E, Zheng L, Wang DW. Association of Systemic Trimethyllysine With Heart Failure With Preserved Ejection Fraction and Cardiovascular Events. J Clin Endocrinol Metab. 2022 Nov 25;107(12):e4360-e4370. doi: 10.1210/clinem/dgac519.

  • Hu D, Xiao L, Li S, Hu S, Sun Y, Wang Y, Wang DW. Prediction of HF-Related Mortality Risk Using Genetic Risk Score Alone and in Combination With Traditional Risk Factors. Front Cardiovasc Med. 2021 Apr 26;8:634966. doi: 10.3389/fcvm.2021.634966. eCollection 2021.

  • Hu D, Li S, Hu S, Sun Y, Xiao L, Li C, Wang J, Wang Y, Ni L, Zhao C, Wang DW. A Common Missense Variant in OMA1 Associated with the Prognosis of Heart Failure. Cardiovasc Drugs Ther. 2020 Jun;34(3):345-356. doi: 10.1007/s10557-020-06960-8.

  • Hu D, Huang J, Hu S, Zhang Y, Li S, Sun Y, Li C, Cui G, Wang DW. A common variant of RIP3 promoter region is associated with poor prognosis in heart failure patients by influencing SOX17 binding. J Cell Mol Med. 2019 Aug;23(8):5317-5328. doi: 10.1111/jcmm.14408. Epub 2019 May 31.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Dao Wen Wang, doctor

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 9, 2018

Study Start

April 18, 2016

Primary Completion

December 31, 2019

Study Completion

December 31, 2020

Last Updated

April 10, 2019

Record last verified: 2019-04

Locations