Heart Failure Clinical Trial
Official title:
Real World Demographic and Clinical Characteristics, Treatment Patterns and Clinical Outcomes of Heart Failure Patients in China: a Retrospective Non-Interventional Nationwide Study
NCT number | NCT03931200 |
Other study ID # | GUSU19002 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 30, 2019 |
Est. completion date | May 18, 2019 |
Verified date | April 2019 |
Source | China Cardiovascular Association |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 60000 |
Est. completion date | May 18, 2019 |
Est. primary completion date | May 18, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: • Concomitant participation in any/a clinical trial with any investigational treatment during the index hospitalization |
Country | Name | City | State |
---|---|---|---|
China | Beijing hospital | Beijing | Beijing |
China | Peking University First Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
China Cardiovascular Association |
China,
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.
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. — View Citation
ISPE. Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug Saf. 2008 Feb;17(2):200-8. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patients' demographics at index hospitalization admission. | Patients' demographics at index hospitalization admission. | 1 years | |
Primary | Patients' medical history at index hospitalization admission. | Patients' medical history at index hospitalization admission. | 1 years | |
Primary | 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 | The percentage of patients who received the guideline (2018 China HF Guideline) recommended tests during the indexed hospitalization. | The percentage of patients who received the guideline (2018 China HF Guideline) recommended tests (i.e. echocardiography, electrocardiogram, brain natriuretic peptide (BNP)/n-terminal pro-brain natriuretic Peptide (NT-proBNP)) during the indexed hospitalization. | 1 years | |
Secondary | 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. | The percentage of HF patients who received the guideline (2018 China HF Guideline) recommended HFrEF pharmacological (i.e. Angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), ARNI, ß-blockers, aldosterone antagonists, diuretics) and device treatments (i.e. ICD, CRT) at the discharge of the index hospitalization. | 1 years | |
Secondary | The percentage of HF patients adherent to guideline. | The percentage of HF patients adherent to guideline (2018 China HF Guideline) recommended HFrEF pharmacological treatments including ACEIs, ARBs, ß-blockers, aldosterone antagonists and diuretics at 1 month, 3 months and 1 year after discharge from the indexed hospitalization. | 1 years | |
Secondary | Follow-up rate at 1month, 3 months and 1 year after discharge from indexed hospitalization. | Follow-up rate at 1month, 3 months and 1 year after discharge from indexed hospitalization. | 1 years | |
Secondary | In-hospital mortality rate at 1month, 3 months and 1 year after discharge from indexed hospitalization. | In-hospital mortality rate at 1month, 3 months and 1 year after discharge from indexed hospitalization. | 1 years | |
Secondary | Re-hospitalization rate at 1month, 3 months and 1 year after discharge from indexed hospitalization. | Re-hospitalization rate at 1month, 3 months and 1 year after discharge from indexed hospitalization. | 1 years | |
Secondary | Demographic characteristics among HF patients stratified by LVEF (<40%/40-49%/=50%). | Demographic characteristics among HF patients stratified by LVEF (<40%/40-49%/=50%). | 1 years | |
Secondary | Medical history among HF patients stratified by LVEF (<40%/40-49%/=50%). | Medical history among HF patients stratified by LVEF (<40%/40-49%/=50%). | 1 years | |
Secondary | Diagnostic pattern among HF patients stratified by LVEF (<40%/40-49%/=50%). | Diagnostic pattern among HF patients stratified by LVEF (<40%/40-49%/=50%). | 1 years | |
Secondary | Treatment pattern among HF patients stratified by LVEF (<40%/40-49%/=50%). | Treatment pattern among HF patients stratified by LVEF (<40%/40-49%/=50%). | 1 years | |
Secondary | Outcomes among HF patients stratified by LVEF (<40%/40-49%/=50%). | Outcomes among HF patients stratified by LVEF (<40%/40-49%/=50%). | 1 years | |
Secondary | Demographic characteristics comparing HF patients in Shanghai vs the whole of China and Shanghai vs the rest of China. | Demographic characteristics comparing HF patients in Shanghai vs the whole of China and Shanghai vs the rest of China. | 1 years | |
Secondary | Medical history comparing HF patients in Shanghai vs the whole of China and Shanghai vs the rest of China. | Medical history comparing HF patients in Shanghai vs the whole of China and Shanghai vs the rest of China. | 1 years | |
Secondary | Diagnostic pattern comparing HF patients in Shanghai vs the whole of China and Shanghai vs the rest of China. | Diagnostic pattern comparing HF patients in Shanghai vs the whole of China and Shanghai vs the rest of China. | 1 years | |
Secondary | Treatment pattern comparing HF patients in Shanghai vs the whole of China and Shanghai vs the rest of China. | Treatment pattern comparing HF patients in Shanghai vs the whole of China and Shanghai vs the rest of China. | 1 years | |
Secondary | Outcomes comparing HF patients in Shanghai vs the whole of China and Shanghai vs the rest of China. | Outcomes comparing HF patients in Shanghai vs the whole of China and Shanghai vs the rest of China. | 1 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Recruiting |
NCT05196659 -
Collaborative Quality Improvement (C-QIP) Study
|
N/A | |
Active, not recruiting |
NCT05896904 -
Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction
|
N/A | |
Completed |
NCT05077293 -
Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
|
||
Recruiting |
NCT05631275 -
The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
|
||
Enrolling by invitation |
NCT05564572 -
Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology
|
N/A | |
Enrolling by invitation |
NCT05009706 -
Self-care in Older Frail Persons With Heart Failure Intervention
|
N/A | |
Recruiting |
NCT04177199 -
What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
|
||
Terminated |
NCT03615469 -
Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY)
|
N/A | |
Recruiting |
NCT06340048 -
Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure
|
Phase 1/Phase 2 | |
Recruiting |
NCT05679713 -
Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
|
||
Completed |
NCT04254328 -
The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure
|
N/A | |
Completed |
NCT03549169 -
Decision Making for the Management the Symptoms in Adults of Heart Failure
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Enrolling by invitation |
NCT05538611 -
Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
|
||
Recruiting |
NCT04262830 -
Cancer Therapy Effects on the Heart
|
||
Completed |
NCT06026683 -
Conduction System Stimulation to Avoid Left Ventricle Dysfunction
|
N/A | |
Withdrawn |
NCT03091998 -
Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support
|
Phase 1 | |
Recruiting |
NCT05564689 -
Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy
|