NCT05538611

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

1.9 years

First QC Date

September 9, 2022

Last Update Submit

September 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    2021.09-2023.09

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

It met the CHF diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2018

You may qualify if:

  • \. 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;

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liangying

Jinan, Shandongsheng, 250014, China

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • ying Liang

    Belong to

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

September 9, 2022

First Posted

September 14, 2022

Study Start

September 30, 2021

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

September 14, 2022

Record last verified: 2022-09

Locations