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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
China1 site, 1 recruiting
- Recruiting
Taizhou People's Hospital affiliated to Nanjing Medical University
Taizhou, Jiangsu, 225300
Yucheng Wu, Doctor, +8618360010750, 2567181759@qq.com
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 group | Role | What they receive |
|---|---|---|
| Routine management group | No intervention | Not described |
| Remote home management group assisted by community physicians | Experimental | Not 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.
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)
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.
- First posted27 Jul 2023
- Study start8 Jun 2023
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Jiangsu Taizhou People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Chu, Jiangsu Taizhou People's Hospital
- Investigators
- Ming Chu, Doctor, Principal investigator, Jiangsu Taizhou People's Hospital
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 29029965Olivier 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 32813350Sverdlov 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 29377057Urtnasan 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 34829400Yang 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 35995955Attia 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 30617318Koehler 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 30153985Wu 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
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT05960890
- Acronym / sponsor ID
- CHF / IIT202305
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Jiangsu Taizhou People's HospitalUniversity, hospital or other
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine management group | No intervention | – |
| Remote home management group assisted by community physicians | Experimental | Behavioral: Remote monitoring assisted by community physicians |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote monitoring assisted by community physiciansPatients 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). | Behavioural | Remote home management group assisted by community physicians |
Primary outcome
incidence of composite event (cardiovascular mortality, unplanned HF hospitalization, emergency HF intervention)
Time frame: 2 years
Cardiovascular disease death, heart failure readmission and emergency HF intervention are three endpoint events, with either occurring as the primary endpoint
1 secondary outcome
all-cause mortality
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Background: PubMed 29029965Zhang 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.
- Background: PubMed 32813350Olivier 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.
- Background: PubMed 29377057Sverdlov 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.
- Background: PubMed 34829400Urtnasan 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.
- Background: PubMed 35995955Yang 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.
- Background: PubMed 30617318Attia 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.
- Background: PubMed 30153985Koehler 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.
- Background: PubMed 35428035Wu 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ming Chu, Doctor principal investigator
Jiangsu Taizhou People's Hospital
1 site in 1 country: see every site and its status.
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.