Cohort Study of Chronic Heart Failure

NCT05960890 | Recruiting

• 1 other identifier: IIT202305
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• incidence of composite event (cardiovascular mortality, unplanned HF hospitalization, emergency HF intervention)

  Cardiovascular disease death, heart failure readmission and emergency HF intervention are three endpoint events, with either occurring as the primary endpoint

  2 years

Secondary Outcomes (1)

• all-cause mortality

  2 years

Other Outcomes (1)

• stroke events

  2 years

Study Arms (2)

Routine management group

NO INTERVENTION

Remote home management group assisted by community physicians

EXPERIMENTAL

Behavioral: Remote monitoring assisted by community physicians

Interventions

Remote monitoring assisted by community physicians BEHAVIORAL

Patients upload data such as wristband data, blood pressure, weight through their mobile phones, while physicians can check the data on the platform. Upon detecting alerts, community physicians review participant-related medical information, conduct structured symptom assessments via "StarNet Home" platform/phone within 2 hours, and initiate protocol-guided interventions (e.g., diuretic adjustment for fluid overload).

Remote home management group assisted by community physicians

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years;
• Fulfill at least one of the following criteria：①History of chronic heart failure;②New-onset heart failure with LVEF \<50%；③New-onset heart failure with LVEF≧50%，E/e'≧15 and BNP\>400 pg/mL/NT-proBNP(\<50 years, \>450 pg/mL; 50\~75 years, \>900 pg/mL; \>75 years, \>1800 pg/mL)
• Etiology: dilated cardiomyopathy, hypertensive heart disease, ischaemic cardiomyopathy, Non-severe valvular heart disease；
• Primary post-discharge therapy: oral medication;
• Sign the informed consent form.

You may not qualify if:

• Patients with renal failure (Ccr\<30ml/min) or patients on dialysis therapy;
• Various correctable secondary causes of cardiac insufficiency including hyperthyroid heart disease, anaemic heart disease, uncorrected congenital heart disease; severe valvular heart disease (including severe stenosis or closure of organic aortic and mitral valves);
• Patients with indications for pacemaker implantation but have not received a pacemaker implant;
• Patients with chronic obstructive pulmonary disease accompanied by type II respiratory failure.
• Patients who cannot understand and sign an informed consent form.
• Patients with mental illness, pregnant women, and other special populations.

Sponsors & Collaborators

• Jiangsu Taizhou People's Hospital: lead

Study Sites (1)

Taizhou People's Hospital affiliated to Nanjing Medical University

Taizhou, Jiangsu, 225300, China

RECRUITING

Related Publications (8)

• 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: 29029965 BACKGROUND

• 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.

  PMID: 32813350 BACKGROUND

• 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.

  PMID: 29377057 BACKGROUND

• 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.

  PMID: 34829400 BACKGROUND

• 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.

  PMID: 35995955 BACKGROUND

• 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.

  PMID: 30617318 BACKGROUND

• 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.

  PMID: 30153985 BACKGROUND

• 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.

  PMID: 35428035 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Ming Chu, Doctor

  Jiangsu Taizhou People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yucheng Wu, Doctor

CONTACT

+8618360010750; 2567181759@qq.com

Lichun Wang, Master

CONTACT

+8613775704547; 18652711566@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The deputy dean of the hospital

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 27, 2023
• Study Start: June 8, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

CN (1)