Impact of Heart Failure Center Program on Cardiac Outcomes in Patients With Heart Failure

March 7, 2024 updated by: luck5748, Chang Gung Memorial Hospital

The Impact of Heart Failure Center Program on The Progression of Biomarkers, Changes in Life Quality, Left Ventricular Ejection Fraction, and Cardiac Outcomes in Patients With Congestive Heart Failure

Congestive heart failure (CHF) is a major public health problem worldwide. CHF carries a devastating prognosis, which resembles that of some types of malignant cancer. Despite substantial improvements in the management of the disease, the prognosis remains poor especially in advanced stages of the disease. For these patients, self-management plan includes monitoring of symptoms such as fatigue and shortness of breath, daily weighing, and knowing what to do if signs of deterioration appear, and when to report the changes to health. The investigators hypothesize that patients in the heart failure management programs that promote self-management by means of intensive education, edema index-assistance, and telephone follow-up can improve their functional status and quality of life, as well as the biomarkers of CHF, left ventricular systolic function, proteinuria and nutritional status.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Congestive heart failure (CHF) is a major public health problem world-wide. CHF carries a devastating prognosis which resembles that of some types of malignant cancer. Its incidence rises steadily from 0.02 per 1000 population per year in those aged 25 to 34 years to 11.6 in those aged 85 years or older. Despite substantial improvements in the management of the disease, the prognosis remains poor especially in advanced stages of the disease. About half of the patients diagnosed with CHF die within 4 years of diagnosis. With the increasing number of patients with CHF being referred from hospital to primary health care, the demands for expanded services in primary health care have increased. Caring for patients with CHF often involves a number of physical, medical, behavioral, psychological and social factors, and requires appropriate attention to all aspects of care, both pharmacological and non-pharmacological. Educating patients about CHF treatment and the consequences of CHF has been shown to improve self-management behavior. For patients with CHF, the self-management plan includes monitoring of symptoms such as fatigue and shortness of breath, daily weighing, and knowing what to do if signs of deterioration appear, and when to report the changes to health care provider. In patients with CHF, the prognosis worsens considerably once malnutrition develops. Mortality at 18 months in unselected patients with CHF in whom cardiac cachexia had been diagnosed was as high as 50% compared to in non-cachectic patients from the same study population. In addition, amount of proteinuria has been known to be related to atherosclerosis burden and disease severity regarding lots of disease entities. The atherosclerosis score is also probably modifiable by life style intervention and educational program. CHF can also activate a few neurohormone and natriuretic peptides, among which brain natriuretic peptide is the most world-wide used. Summarized, in this study, to estimate the effect of CHF education and self-management program, the parameters adopted include blood brain natriuretic peptide and albumin levels, atherosclerosis scores, proteinuria, renal function, changes in life quality, left ventricular ejection fraction, and cardiac outcomes. In Taiwan, so far, the investigators don't have this kind of CHF education and self-care system. The investigators hypothesize that patients in the heart failure management programs that promote self-management by means of intensive education, edema index-assistance, and telephone follow-up can improve their functional status and quality of life, as well as the biomarkers of CHF, left ventricular systolic function, proteinuria and nutritional status.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
470

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Keelung, Taiwan, 402
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalized due to acute cardiogenic pulmonary edema will be consecutively enrolled in the HF center of Chang Gung Memorial Hospital.

Description

Inclusion Criteria:

  1. patients hospitalized due to acute cardiogenic pulmonary edema documented on chest x-ray and
  2. left ventricular ejection fraction (LVEF) < 40% as documented by echocardiography; and
  3. aged > 20 and < 80 years.

Exclusion Criteria:

  1. the presence of systemic diseases such as hypothyroidism, decompensated liver cirrhosis, and systemic lupus erythematosus;
  2. a disorder other than HF that might compromise survival within 6 months;
  3. having implanted materials that could interfere with the bioimpedance analysis,
  4. being bed-ridden for > 3 months and/or unable to stand alone;
  5. having serum creatinine of > 5 mg/dl or nephritic syndrome;
  6. having active cellulites, severe varicose veins, lymphedema or deep vein thrombosis over lower extremity;
  7. undergoing dialysis within 2 weeks;
  8. having severe coronary artery disease without complete revascularization therapy; and
  9. being pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
control group
control group receiving regular education from a nurse
Case management group
This is the study group. Extensive education and case management program will be performed in this group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
All-cause Death, Heart Failure-related Re-hospitalizations, and a Composite Outcome of Both Death and Heart Failure-related Re-hospitalizations
Time Frame: 2 year
Follow-up began after randomization. Follow-up data were prospectively obtained every month from hospital records, personal communication with patients' physicians, telephone interviews, and records of regular visits to staff physicians' outpatient clinics. 'Re-hospitalization'was defined as heart failure-related re-hospitalization.'All causes of death' was also considered to be an event. All-cause death was chosen as an endpoint because of the inter-relationship of heart failure with many other comorbidities in the patient cohort. A committee of three cardiologists adjudicated all hospitalizations without knowledge of the patients' clinical data to determine whether events were related to worsening heart failure. Based on these two different endpoints, time to the first event was analyzed.
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: CHAO-HUNG WANG, MD, Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2011

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 98-1154B
  • CMRPG280251 (Other Grant/Funding Number: CHANG GUNG MEMORIAL HOSPITAL)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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