AzTrials
AzTrials

Heart FailureCHFNCT05960890

Cohort Study of Chronic Heart Failure

A study testing Remote monitoring assisted by community physicians in people with Heart Failure, run by Jiangsu Taizhou People's Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Remote monitoring assisted by community physicians
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
1 siteChina
Study dates
8 Jun 2023to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yucheng Wu, Doctor contact

+8618360010750

2567181759@qq.com

Lichun Wang, Master contact

+8613775704547

18652711566@163.com

China1 site, 1 recruiting

  • Taizhou People's Hospital affiliated to Nanjing Medical University

    Taizhou, Jiangsu, 225300

    Yucheng Wu, Doctor, +8618360010750, 2567181759@qq.com

    Recruiting

Other trials in China

About this study

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
Being tested
Remote monitoring assisted by community physicians
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remote monitoring assisted by community physiciansBehavioural

    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).

Study groups in NCT05960890
Study groupRoleWhat they receive
Routine management groupNo interventionNot described
Remote home management group assisted by community physiciansExperimentalNot described
Receives: Behavioral: Remote monitoring assisted by community physicians

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2 years

Secondary outcomes (1)

  1. all-cause mortality

    all-cause mortality

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2023
  2. Study start8 Jun 2023
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05960890
Sponsor's protocol ID
IIT202305
Acronym
CHF
Status last verified
May 2026
First submitted
7 Jul 2023
Last updated
20 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 29029965

  • 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.

    PubMed 32813350

  • 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.

    PubMed 29377057

  • 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.

    PubMed 34829400

  • 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.

    PubMed 35995955

  • 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.

    PubMed 30617318

  • 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.

    PubMed 30153985

  • 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.

    PubMed 35428035

Questions about this trial

What is this clinical trial studying?

A study testing Remote monitoring assisted by community physicians in people with Heart Failure, run by Jiangsu Taizhou People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yucheng Wu, Doctor (+8618360010750, 2567181759@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of composite event (cardiovascular mortality, unplanned HF hospitalization, emergency HF intervention) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05960890, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.

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