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

NCT01416285 | Completed Results DMC

• 2 other identifiers: 98-1154BCMRPG280251
• Study Type: observational
• Target: 470
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Death; Congestive Heart Failure

Keywords

Congestive heart failure (CHF); CHF education; self-care training; CHF center

Outcome Measures

Primary Outcomes (1)

• All-cause Death, Heart Failure-related Re-hospitalizations, and a Composite Outcome of Both Death and Heart Failure-related Re-hospitalizations

  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

Study Arms (2)

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.

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Keelung, 402, Taiwan

Location

Related Publications (5)

• Jaarsma T, van der Wal MH, Lesman-Leegte I, Luttik ML, Hogenhuis J, Veeger NJ, Sanderman R, Hoes AW, van Gilst WH, Lok DJ, Dunselman PH, Tijssen JG, Hillege HL, van Veldhuisen DJ; Coordinating Study Evaluating Outcomes of Advising and Counseling in Heart Failure (COACH) Investigators. Effect of moderate or intensive disease management program on outcome in patients with heart failure: Coordinating Study Evaluating Outcomes of Advising and Counseling in Heart Failure (COACH). Arch Intern Med. 2008 Feb 11;168(3):316-24. doi: 10.1001/archinternmed.2007.83.

  PMID: 18268174 RESULT

• Hoekstra T, Lesman-Leegte I, van der Wal M, Luttik ML, Jaarsma T. Nurse-led interventions in heart failure care: patient and nurse perspectives. Eur J Cardiovasc Nurs. 2010 Dec;9(4):226-32. doi: 10.1016/j.ejcnurse.2010.01.006. Epub 2010 Mar 4.

  PMID: 20202912 RESULT

• Riegel B, Lee CS, Dickson VV; Medscape. Self care in patients with chronic heart failure. Nat Rev Cardiol. 2011 Jul 19;8(11):644-54. doi: 10.1038/nrcardio.2011.95.

  PMID: 21769111 RESULT

• Mao CT, Liu MH, Hsu KH, Fu TC, Wang JS, Huang YY, Yang NI, Wang CH. Effect of multidisciplinary disease management for hospitalized heart failure under a national health insurance programme. J Cardiovasc Med (Hagerstown). 2015 Sep;16(9):616-24. doi: 10.2459/JCM.0000000000000089.

  PMID: 25105284 DERIVED

• Liu MH, Wang CH, Huang YY, Tung TH, Lee CM, Yang NI, Liu PC, Cherng WJ. Edema index established by a segmental multifrequency bioelectrical impedance analysis provides prognostic value in acute heart failure. J Cardiovasc Med (Hagerstown). 2012 May;13(5):299-306. doi: 10.2459/JCM.0b013e328351677f.

  PMID: 22367574 DERIVED

Related Links

• European Society of Cardiology, Heart Failure association

Biospecimen

Retention: SAMPLES WITHOUT DNA

At baseline and every 6-month visits, 3 ml of venous blood will be collected. At baseline and each 6-month visit, urinary albumin amount will be measured in the core lab in the hospital.

MeSH Terms

Conditions

Death; Heart Failure

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: CHAO-HUNG WANG, MD
• Organization: Chang Gung Memorial Hospital

bearty54@gmail.com

+886-2-24313131

Study Officials

• CHAO-HUNG WANG, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Heart Failure Research Center

Study Record Dates

• First Submitted: August 11, 2011
• First Posted: August 15, 2011
• Study Start: June 1, 2010
• Primary Completion: May 30, 2012
• Study Completion: May 30, 2012
• Last Updated: March 8, 2024
• Results First Posted: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)