Cohort Study of Chronic Heart Failure

Heart Failure Clinical Trial

— CHF  

Official title:

Cohort Study of Chronic Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05960890
• Other study ID #: IIT202305
• Status: Recruiting
• Start date: June 8, 2023
• Est. completion date: December 2026

Study information

• Verified date: July 2023
• Source: Jiangsu Taizhou People's Hospital
• Contact: Yucheng Wu, Doctor
• Phone: +8618360010750
• Email: 2567181759[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to learn about the influencing factors of chronic heart failure prognosis in heart failure patients. The main question it aims to answer is that what are the influencing factors of clinical outcomes in chronic heart failure. Participants will be collected multiple omics data such as phenotype group, environmental exposure group, intestinal microbiome, genome, metabolome, and noninvasive biomarkers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Over 18 years old

2. Dilated cardiomyopathy, hypertensive cardiomyopathy, ischemic cardiomyopathy (coronary heart disease), non-severe valvular heart disease

3. LVEF<50%, and/or NT-proBNP>1800ng/L, and/or BNP>100ng/L, NYHA I-III grade

4. Able to understand and sign informed consent forms

Exclusion Criteria:

1. Expected life less than 3 months

2. Patients with severe renal insufficiency (Ccr<30ml/min) or undergoing dialysis treatment

3. Cardiac insufficiency caused by various secondary causes that can be corrected includes hyperthyroid heart disease, anemic heart disease, and uncorrected Congenital heart defect

4. Presence of indications for pacemaker implantation and absence of pacemaker implantation

5. Chronic obstructive pulmonary disease with type II Respiratory failure

6. Special populations such as mental illness patients and pregnant women

7. Unable to understand and sign informed consent form

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
China	Taizhou People's Hospital affiliated to Nanjing Medical University	Taizhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Taizhou People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

Attia ZI, Kapa S, Lopez-Jimenez F, McKie PM, Ladewig DJ, Satam G, Pellikka PA, Enriquez-Sarano M, Noseworthy PA, Munger TM, Asirvatham SJ, Scott CG, Carter RE, Friedman PA. Screening for cardiac contractile dysfunction using an artificial intelligence-enabled electrocardiogram. Nat Med. 2019 Jan;25(1):70-74. doi: 10.1038/s41591-018-0240-2. Epub 2019 Jan 7. — View Citation

Koehler F, Koehler K, Deckwart O, Prescher S, Wegscheider K, Kirwan BA, Winkler S, Vettorazzi E, Bruch L, Oeff M, Zugck C, Doerr G, Naegele H, Stork S, Butter C, Sechtem U, Angermann C, Gola G, Prondzinsky R, Edelmann F, Spethmann S, Schellong SM, Schulze PC, Bauersachs J, Wellge B, Schoebel C, Tajsic M, Dreger H, Anker SD, Stangl K. Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial. Lancet. 2018 Sep 22;392(10152):1047-1057. doi: 10.1016/S0140-6736(18)31880-4. Epub 2018 Aug 25. — View Citation

Olivier B, Verdonck M, Caseleijn D. Digital technologies in undergraduate and postgraduate education in occupational therapy and physiotherapy: a scoping review. JBI Evid Synth. 2020 May;18(5):863-892. doi: 10.11124/JBISRIR-D-19-00210. — View Citation

Sverdlov O, van Dam J, Hannesdottir K, Thornton-Wells T. Digital Therapeutics: An Integral Component of Digital Innovation in Drug Development. Clin Pharmacol Ther. 2018 Jul;104(1):72-80. doi: 10.1002/cpt.1036. Epub 2018 Feb 23. — View Citation

Urtnasan E, Joo EY, Lee KH. AI-Enabled Algorithm for Automatic Classification of Sleep Disorders Based on Single-Lead Electrocardiogram. Diagnostics (Basel). 2021 Nov 5;11(11):2054. doi: 10.3390/diagnostics11112054. — View Citation

Wu Y, Lin J, Gong B, Wang L, Ruan Z, Xu K. Cardiac Rehabilitation in Atrial Fibrillation Patients With Left Atrial Appendage Occlusion: A RANDOMIZED TRIAL. J Cardiopulm Rehabil Prev. 2022 Jul 1;42(4):266-271. doi: 10.1097/HCR.0000000000000693. Epub 2022 Apr 13. — View Citation

Yang Y, Yuan Y, Zhang G, Wang H, Chen YC, Liu Y, Tarolli CG, Crepeau D, Bukartyk J, Junna MR, Videnovic A, Ellis TD, Lipford MC, Dorsey R, Katabi D. Artificial intelligence-enabled detection and assessment of Parkinson's disease using nocturnal breathing signals. Nat Med. 2022 Oct;28(10):2207-2215. doi: 10.1038/s41591-022-01932-x. Epub 2022 Aug 22. — 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite endpoint of cardiovascular death and rehospitalization for heart failure	Cardiovascular disease death and heart failure readmission are two endpoint events, with either occurring as the primary endpoint	2 years
Secondary	all-cause mortality	all-cause mortality	2 years