Heart FailureHFNCT05538611
Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
An observational study of Heart Failure, run by Liangying at 1 site in China.
Trial summary
Heart failure is a chronic disease that spans the home as well as the outpatient and hospital Settings and requires multidisciplinary, continuous disease management. Heart failure management emphasizes seamless connection from admission to return to the family, so as to improve the efficiency of resource use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2021to Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: It met the CHF diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2018
Who may be able to join
- 1. Patients with BNP > 100ng/ml in laboratory examination or LVEF < 50% in ultrasound ECG; 2. Meeting the CHF diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2018; 3. Patients with cardiac function stage A-C: stage A, patients with high risk factors for heart failure (hypertension, coronary heart disease, diabetes and obesity, metabolic syndrome, history of cardiotoxic drugs, history of alcoholism, history of rheumatic fever, family history of cardiomyopathy, etc.); In stage B, cardiac structural changes (left ventricular hypertrophy, asymptomatic valvular heart disease, previous myocardial infarction) were present; In stage C, the patient has structural changes in the heart and has symptoms and/or signs of heart failure (dyspnea, fluid retention, edema of both lower limbs, etc.) in the past or present; 4. Patients with NYHA (New York Cardiology Society) cardiac function grade I to IV; 5. Age > 18, both sexes; 6. No mental disorder, clear consciousness and normal communication; 7. Non-pregnant and lactating women;
Who cannot join
- 1. Severe valvular disease, pericardial disease, cardiomyopathy, congenital heart disease, acute myocardial infarction (within 4 weeks), cardiogenic shock, acute myocarditis, severe arrhythmia with hemodynamic changes; 2. Patients with pulmonary heart disease, pulmonary hypertension caused by acute and chronic pulmonary embolism, and stroke in the past six months; 3. Complicated with other serious acute and chronic diseases, such as liver and renal failure, respiratory failure, malignant tumor, diabetes with serious complications, hyperthyroidism, hypothyroidism and other serious endocrine diseases; Autoimmune diseases, etc.; 4. Pregnant or lactating women; 5. Patients with mental disorders or verbal communication or cognitive disorders; 6. patients with infectious diseases; 8. The residence area is not fixed, and it is difficult to complete the follow-up or loss of follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Management Effect of "Special-general-practice-community-family" Chain Quality Control Model With General Practice Department as the Core in General Hospitals on Patients With Chronic Heart Failure
Heart failure is a chronic disease that spans the home as well as the outpatient and hospital Settings and requires multidisciplinary, continuous disease management. Heart failure management emphasizes seamless connection from admission to return to the family, so as to improve the efficiency of resource use. Early preventive intervention, timely and reasonable drug treatment, integration of effective medical resources, and establishment of A sound and effective management model should be carried out for the population with high risk factors of heart failure (heart function stage A), so as to delay the occurrence and development of heart failure and further avoid the occurrence of malignant cardiovascular events. Therefore, this project aims to establish a "special-general-community-family" chain quality control model with the "general practice department" as the core for patients with chronic heart failure in general hospitals, so as to provide them with a full life cycle, multidimensional, concise and efficient quality control management.At present, the situation of heart failure prevention and treatment in China is grim and the challenge is huge. Heart failure complicated illness, drug dosage adjustment characteristics of professionalism, its emphasis on guide oriented treatment, and should pay attention to individual, need of specialized subject doctor, general practitioners, community doctors and family personal collaborative to maximize the optimal management of patients with chronic heart failure, follow the classification diagnosis and treatment, two-way referral is helpful to improve the long-term prognosis of patients with. At present, HF management has received increasing attention, how to choose a more reasonable, effective and economic management mode is still a problem of disagreement.
Read the detailed description
At present, there is no unified and publicly recognized management model at home and abroad, and most studies only involve the use of one or a few measures, while the organic combined application of various measures is rarely reported. To enable patients to have a better quality of life and life, and to establish a standardized and suitable quality control management mode for heart failure is one of the hot topics in the cardiovascular field.
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Trend of adverse cardiovascular events after chain management of heart failure in general practice
The incidence of adverse cardiovascular events in patients with heart failure after chain management in general practice has a significant downward trend
Measured: 2021.09-2023.09
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start30 Sep 2021
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liangying
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liangying, Qianfoshan Hospital
- Investigators
- ying Liang, Principal investigator, Belong to
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538611
- Sponsor's protocol ID
- YXLL-KY-2022 (023)
- Acronym
- HF
- Status last verified
- Sep 2022
- First submitted
- 9 Sep 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Management Effect of "Special-general-practice-community-family" Chain Quality Control Model With General Practice Department as the Core in General Hospitals on Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT05538611
- Acronym / sponsor ID
- HF / YXLL-KY-2022 (023)
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- LiangyingUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 14 Sep 2022 (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.
Heart failure is a chronic disease that spans the home as well as the outpatient and hospital Settings and requires multidisciplinary, continuous disease management. Heart failure management emphasizes seamless connection from admission to return to the family, so as to improve the efficiency of resource use. Early preventive intervention, timely and reasonable drug treatment, integration of effective medical resources, and establishment of A sound and effective management model should be carried out for the population with high risk factors of heart failure (heart function stage A), so as to delay the occurrence and development of heart failure and further avoid the occurrence of malignant cardiovascular events. Therefore, this project aims to establish a "special-general-community-family" chain quality control model with the "general practice department" as the core for patients with chronic heart failure in general hospitals, so as to provide them with a full life cycle, multidimensional, concise and efficient quality control management.At present, the situation of heart failure prevention and treatment in China is grim and the challenge is huge. Heart failure complicated illness, drug dosage adjustment characteristics of professionalism, its emphasis on guide oriented treatment, and should pay attention to individual, need of specialized subject doctor, general practitioners, community doctors and family personal collaborative to maximize the optimal management of patients with chronic heart failure, follow the classification diagnosis and treatment, two-way referral is helpful to improve the long-term prognosis of patients with. At present, HF management has received increasing attention, how to choose a more reasonable, effective and economic management mode is still a problem of disagreement.
Detailed description
At present, there is no unified and publicly recognized management model at home and abroad, and most studies only involve the use of one or a few measures, while the organic combined application of various measures is rarely reported. To enable patients to have a better quality of life and life, and to establish a standardized and suitable quality control management mode for heart failure is one of the hot topics in the cardiovascular field.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It met the CHF diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2018
Key inclusion criteria (1 listed)
- 1. Patients with BNP > 100ng/ml in laboratory examination or LVEF < 50% in ultrasound ECG; 2. Meeting the CHF diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2018; 3. Patients with cardiac function stage A-C: stage A, patients with high risk factors for heart failure (hypertension, coronary heart disease, diabetes and obesity, metabolic syndrome, history of cardiotoxic drugs, history of alcoholism, history of rheumatic fever, family history of cardiomyopathy, etc.); In stage B, cardiac structural changes (left ventricular hypertrophy, asymptomatic valvular heart disease, previous myocardial infarction) were present; In stage C, the patient has structural changes in the heart and has symptoms and/or signs of heart failure (dyspnea, fluid retention, edema of both lower limbs, etc.) in the past or present; 4. Patients with NYHA (New York Cardiology Society) cardiac function grade I to IV; 5. Age > 18, both sexes; 6. No mental disorder, clear consciousness and normal communication; 7. Non-pregnant and lactating women;
Key exclusion criteria (1 listed)
- 1. Severe valvular disease, pericardial disease, cardiomyopathy, congenital heart disease, acute myocardial infarction (within 4 weeks), cardiogenic shock, acute myocarditis, severe arrhythmia with hemodynamic changes; 2. Patients with pulmonary heart disease, pulmonary hypertension caused by acute and chronic pulmonary embolism, and stroke in the past six months; 3. Complicated with other serious acute and chronic diseases, such as liver and renal failure, respiratory failure, malignant tumor, diabetes with serious complications, hyperthyroidism, hypothyroidism and other serious endocrine diseases; Autoimmune diseases, etc.; 4. Pregnant or lactating women; 5. Patients with mental disorders or verbal communication or cognitive disorders; 6. patients with infectious diseases; 8. The residence area is not fixed, and it is difficult to complete the follow-up or loss of follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Trend of adverse cardiovascular events after chain management of heart failure in general practice
Time frame: 2021.09-2023.09
The incidence of adverse cardiovascular events in patients with heart failure after chain management in general practice has a significant downward trend
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
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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. This study is not recruiting at the moment.
ying Liang principal investigator
Belong to
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Liangying 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trend of adverse cardiovascular events after chain management of heart failure in general practice (time frame: 2021.09-2023.09). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2022.