Hospital-Community-Family-Care Management Platform for Chronic Heart Failure

  • STATUS
    Recruiting
  • days left to enroll
    24
  • participants needed
    1000
  • sponsor
    Xiang Gu
Updated on 28 July 2019
Investigator
Xiang Gu, Doctor
Primary Contact
Department of cardiovascular medicine,Northern Jiangsu Hospital (2.0 mi away) Contact
medical therapy
ejection fraction
heart disease
ace inhibitor
cardiomyopathy
angiotensin

Summary

The purpose of this study is to determine whether the Hospital-Community-Family-Care Management Platform for Chronic Heart Failure reduces the mortality, readmission rates and costs of the subjects with CHF.

Description

(1) Indication: Chronic Heart Failure. (2) Objectives: Primary objective is to evaluate the efficacy of the Hospital-Community-Family-Care Management Platform online compared with the regular clinic follow up in subjects with CHF (I-IV class by NYHA, of which class IV without strict bed rest).Secondary objectives is to assess the safety of the Management Platform online in subjects with CHF. (3) Study design: Prospective, randomized, controlled study with two follow up management groups: 1) the Hospital-Community-Family-Care Management Follow up Online; 2) the regular monthly clinic follow up. Study population: Totally 1000 male and female subjects with CHF (I-IV functional class according to NYHA classification). (4) Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing. (5) Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry. (6) Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources. (7) Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management. (8) Duration of follow up: The total follow-up time shall be at least 12 months. (9) Safety Assessment: Safety of the study will be evaluated by the following assessments: 1) Subject and object examinations (during the follow up period and extending up to 2 week after the end of the study) consisting of a subject interview (including direct questioning about adverse events), physical examination, assessment of body weight, Electrocardiogram (ECG) and echocardiogram (UCG), Left ventricular ejection fraction (LVEF), assessed by echocardiography, The N-terminal prohormone of brain natriuretic peptide (NT-proBNP), a peptide hormone whose plasma concentration is inversely related to the severity of HF, NYHA functional status, assessed by subject interview, 6-minute walk distance (6MWD), Quality of life (QoL), assessed by the Minnesota Living with Heart Failure questionnaire (MLHFQ), a validated questionnaire assessing QoL in subjects with heart failure. 2) Evaluation of clinically relevant safety laboratory parameters, such as complete blood count, serum creatinine, electrolytes, and liver enzymes. Any Adverse Events (AE) or Serious Adverse Events (SAE) and its potential causal relationship with the study will be recorded and evaluated.

Details
Treatment Hospital-Community-Family-Care Management Platform Online, Subjects with CHF via conventional clinic visit according to the latest relevant guidelines
Clinical Study IdentifierNCT02029287
SponsorXiang Gu
Last Modified on28 July 2019

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Chronic Heart Failure?
Inclusion Criteria:to be considered eligible to participate
in this study, a subject must meet the inclusion criteria listed below at the
time of screening and
randomization
Male and female are aged 18 years old or over
History of CHF for 3 months with NYHA functional class I-IV, of which class IV without strict bed rest
Left ventricular ejection fraction (LVEF) 45% as assessed by echocardiogram. However, LVEF can be above 45% for patients with cardiac insufficiency caused by atrial fibrillation, valvular heart disease, hypertrophic cardiomyopathy and et al
Treatment of CHF with stable and optimal pharmacological therapy according to Chinese guidelines for treatment of CHF. In general, optimal treatment will include a beta-blocker and an ACE inhibitor and/or an angiotensin receptor blocker, unless not tolerated. Medical therapy is defined as stable, if the subject has not started a new CHF drug class and the dose of drugs taken have not been changed during the 3 months prior to screening and randomization
Ability to understand the requirements of the study and willingness to provide written informed consent (IC), and agreement to abide by the study restrictions and return for the required assessments
Subjects are located in our coverage of the remote monitoring system

Exclusion Criteria

To be eligible for entry into the study, the subject must
not meet any of the exclusion criteria listed below at screening and
randomization
Some secondary cardiomyopathy: hyperthyroid heart disease and anemic heart disease, and et al
A history of malignancy, and life expectancy is less than 1 year
Severe primary hepatic and renal insufficiency (alanine aminotransferase100 u/L, serum creatinine >3.0mg/dL, serum albumin 2.5g/L)
Refusal to participate
Unable to visit outpatient clinics periodically
Ambulatory population
Patients were considered inappropriate to participate by researchers
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