NCT03931200

Brief Summary

This is a non-interventional, multicenter, retrospective study assessing demographic characteristics, clinical characteristics, management and outcome of patients with a HF (heart failure) diagnosis utilizing real world data derived from HF Center Database. This database collects the data of HF from patients hospitalized between March 2010 to Dec 2018 in more than 300 hospitals across China.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

April 15, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 30, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

April 30, 2019

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2019

Completed
Last Updated

May 21, 2019

Status Verified

April 1, 2019

Enrollment Period

18 days

First QC Date

April 15, 2019

Last Update Submit

May 18, 2019

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (3)

  • Patients' demographics at index hospitalization admission.

    Patients' demographics at index hospitalization admission.

    1 years

  • Patients' medical history at index hospitalization admission.

    Patients' medical history at index hospitalization admission.

    1 years

  • Patients' comorbidities (i.e. diabetes, renal insufficiency, chronic obstructive pulmonary disease, anemia, obesity, hypertension) at index hospitalization admission.

    Patients' comorbidities (i.e. diabetes, renal insufficiency, chronic obstructive pulmonary disease, anemia, obesity, hypertension) at index hospitalization admission.

    1 years

Secondary Outcomes (16)

  • The percentage of patients who received the guideline (2018 China HF Guideline) recommended tests during the indexed hospitalization.

    1 years

  • The percentage of HF patients who received the guideline (2018 China HF Guideline) recommended HFrEF (Hear failure with reduced ejection fraction) pharmacological and device treatments (i.e. ICD, CRT) at the discharge of the index hospitalization.

    1 years

  • The percentage of HF patients adherent to guideline.

    1 years

  • Follow-up rate at 1month, 3 months and 1 year after discharge from indexed hospitalization.

    1 years

  • In-hospital mortality rate at 1month, 3 months and 1 year after discharge from indexed hospitalization.

    1 years

  • +11 more secondary outcomes

Eligibility Criteria

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

The demographic and clinical characteristics were collected from patients' medical records during their in-patients treatment period, and the follow-up data were collected from face-to-face interview at outpatient clinics or phone interview after discharge.

You may qualify if:

  • Aged 18 years and older
  • Patients with confirmed diagnosis of HF
  • Diagnosis is made by the treating physicians according to local practices and their clinical judgement

You may not qualify if:

  • Concomitant participation in any/a clinical trial with any investigational treatment during the index hospitalization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Beijing hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (4)

  • Gu DF, Huang GY, He J, et al (2003). Investigation of prevalence and distributing feature of chronic heart failure in Chinese adult population. Chin J Cardiol, Vol.31,pp.3-6.

    BACKGROUND

  • Huang J, Yin H, Zhang M, Ni Q, Xuan J. Understanding the economic burden of heart failure in China: impact on disease management and resource utilization. J Med Econ. 2017 May;20(5):549-553. doi: 10.1080/13696998.2017.1297309. Epub 2017 Mar 12.

    PMID: 28286996BACKGROUND

  • Zhang Y, Zhang J, Butler J, Yang X, Xie P, Guo D, Wei T, Yu J, Wu Z, Gao Y, Han X, Zhang X, Wen S, Anker SD, Filippatos G, Fonarow GC, Gan T, Zhang R; China-HF Investigators. Contemporary Epidemiology, Management, and Outcomes of Patients Hospitalized for Heart Failure in China: Results From the China Heart Failure (China-HF) Registry. J Card Fail. 2017 Dec;23(12):868-875. doi: 10.1016/j.cardfail.2017.09.014. Epub 2017 Oct 10.

    PMID: 29029965BACKGROUND

  • ISPE. Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug Saf. 2008 Feb;17(2):200-8. doi: 10.1002/pds.1471. No abstract available.

    PMID: 17868186BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2019

First Posted

April 30, 2019

Study Start

April 30, 2019

Primary Completion

May 18, 2019

Study Completion

May 18, 2019

Last Updated

May 21, 2019

Record last verified: 2019-04

Locations

CN(2)