Trial record 7 of 1175 for:    Open Studies | "Hospitals"

Hospital-Community-Family-Care Management Platform for Chronic Heart Failure (HCF-CMP-CHF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Northern Jiangsu Province People's Hospital
Sponsor:
Collaborators:
Science and Technology Department of Jiangsu Province
Yangzhou Municipal Health Bureau
Information provided by (Responsible Party):
Xiang Gu, Northern Jiangsu Province People's Hospital
ClinicalTrials.gov Identifier:
NCT02029287
First received: December 21, 2013
Last updated: January 5, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Chronic Heart Failure
Other: Hospital-Community-Family-Care Management Platform Online

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Remote Prevention and Treatment Based on Community Under the Guidance of Regional Central Hospital for Patients With Chronic Heart Failure

Resource links provided by NLM:


Further study details as provided by Northern Jiangsu Province People's Hospital:

Primary Outcome Measures:
  • all cause mortality [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Number of subjects with all cause death


Secondary Outcome Measures:
  • Heart failure morbidity [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    number of subjects with heart failure - related visits


Other Outcome Measures:
  • heart failure worsening [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Number of subjects requiring drug or dose changes to intensify concomitant therapy due to worsening of heart failure (HF).

  • Hospitalization rate [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Hospitalization rate associated with heart failure

  • Costs of medications [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Costs of medications associated with heart failure


Estimated Enrollment: 1000
Study Start Date: December 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects with CHF follow-up
Subjects with Hospital-Community-Family-Care Management Platform online and those with the clinic follow up.
Other: Hospital-Community-Family-Care Management Platform Online
Hospital-Community-Family-Care Management Platform Online: the remote monitoring service platform on line based on community and family for subjects with CHF under the guidance of the regional central hospital

Detailed 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 (II-III class by NYHA).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 (II-III functional classes 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 12 months.(9)Safety Assessment:Safety of the study will be evaluated by the following assessments: 1)Subject 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, 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, 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.(10)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

1000 subjects with chronic, moderate heart failure (NYHA functional class II-III) with reduced ejection fraction (≤45%) will be enrolled (500 randomly allocated to receive and 500 to receive placebo in addition to standard therapy). Determination of study eligibility will be established by the Investigator on the basis of the inclusion and exclusion criteria.

Criteria

Inclusion Criteria: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:

  1. Male and female subject≥18 years of age.
  2. History of CHF for ≥3 months with NYHA functional class II-III.
  3. Left ventricular ejection fraction ≤45% as assessed by echocardiogram.
  4. 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.
  5. 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.
  6. 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:

  1. Abnormal renal or hepatic function, defined as ALT≥100 u/L, serum creatinine >3.0mg/dL, serum albumin <2.5g/L.
  2. Hemoglobin concentration≤8.0g/dL.
  3. Obesity (body mass index >35kg/m2).
  4. Heart failure primarily due to valvular heart disease, or clinically significant valvular heart disease that is expected to require surgical correction within 12 months after randomization.
  5. Implantable cardiac defibrillator (ICD) within 30 days prior to randomization, or initiation of cardiac resynchronization therapy (CRT with/without ICD) within 30 days prior to randomization.
  6. Routinely scheduled IV infusions for HF (e.g., inotropes, vasodilators, diuretics).
  7. Acute myocardial infarction or cerebrovascular accident within 6 months prior to randomization.
  8. Percutaneous intervention (coronary, cerebrovascular, aortic) within 6 months prior to randomization.
  9. Major surgery, including thoracic or cardiac surgery, within 3 months prior to randomization.
  10. Symptomatic tachyarrhythmia with an uncontrolled ventricular response (>100 bpm at rest) or an untreated symptomatic bradyarrhythmia within 1 month prior to randomization.
  11. Hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis.
  12. Likelihood of cardiac transplantation within 12 months after randomization.
  13. Peripheral artery disease, which interferes with 6 minutes walking test.
  14. Chronic obstructive pulmonary disease, which interferes with 6 minutes walking test.
  15. History of major organ transplant (e.g., lung, liver, heart, bone marrow) or renal replacement therapy.
  16. Serious anaemia secondary to acute or chronic bleeding.
  17. Whole blood or red blood cell (RBC) transfusion within 8 weeks prior to randomization.
  18. Severe concomitant non-cardiovascular disease that is expected to reduces life expectancy to less than 3 years.
  19. History of any neoplastic disease.
  20. Known active systemic hematologic disease (e.g., sickle cell anemia, myelodysplastic syndromes, hematologic malignancy, myeloma, hemolytic anemia), hemolysis due to any cause, thalassemia.
  21. Untreated hypo- or hyperthyroidism, adrenal insufficiency, active vasculitis due to collagen vascular disease.
  22. Use of any erythropoietic protein (eg, rHuEPO) within 12 weeks prior to randomization.
  23. Pregnancy (e.g. positive human chorionic gonadotropin [HCG] test) or active lactation.
  24. Currently or recently (<30 days) enrolled in clinical trials or other investigational devices, or currently receiving other investigational agent(s) or procedure(s).
  25. Disorder that compromises the ability of the subject to give written informed consent or to comply with study procedures.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02029287

Contacts
Contact: Xiang Gu, Doctor +86 0514 87373366 sbyygx189@gmail.com

Locations
China, Jiangsu
Department of cardiovascular medicine,Northern Jiangsu Hospital Recruiting
Yangzhou, Jiangsu, China, 225001
Contact: Jianhua Shen, Doctor    +86 0514 87373367      
Sub-Investigator: Lei Sun, Master         
Sub-Investigator: Ye Zhu, Master         
Sub-Investigator: Shuhang Miao, Bachelor         
Sub-Investigator: Yi Zhang, Master         
Sub-Investigator: Zhengyu Bao, Doctor         
Sub-Investigator: Ming Gu, Master         
Sub-Investigator: Hui Li, Bachler         
Sub-Investigator: Fei Hang, Master         
Sponsors and Collaborators
Xiang Gu
Science and Technology Department of Jiangsu Province
Yangzhou Municipal Health Bureau
Investigators
Principal Investigator: Xiang Gu, Docter Department of cardiovascular medicine
Principal Investigator: Jianhua Shen, Docter Department of cardiovascular medicine
  More Information

No publications provided

Responsible Party: Xiang Gu, Professor of Cardiology, Director of Cardiovascular Medicine, Northern Jiangsu Province People's Hospital
ClinicalTrials.gov Identifier: NCT02029287     History of Changes
Other Study ID Numbers: BL2013022
Study First Received: December 21, 2013
Last Updated: January 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northern Jiangsu Province People's Hospital:
Chronic heart failure
telemedicine
health service platform

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014