DeathNCT01416285
Impact of Heart Failure Center Program on Cardiac Outcomes in Patients With Heart Failure
An observational study of Death and Congestive Heart Failure, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Death, Congestive Heart Failure
- How many people
- 470 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2010to 30 May 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized due to acute cardiogenic pulmonary edema will be consecutively enrolled in the HF center of Chang Gung Memorial Hospital.
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- undergoing dialysis within 2 weeks;
- having severe coronary artery disease without complete revascularization therapy; and
- being pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Death, Congestive Heart Failure
- Keywords
- Congestive heart failure (CHF), CHF education, self-care training, CHF center
- Medical subject headings
- Death, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study start1 Jun 2010
- Primary completion30 May 2012
- Study completion30 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DeathStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, luck5748, Chang Gung Memorial Hospital
- Investigators
- CHAO-HUNG WANG, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416285
- Sponsor's protocol ID
- 98-1154B
- Other IDs
- CMRPG280251
- Status last verified
- Mar 2024
- First submitted
- 11 Aug 2011
- Last updated
- 8 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 18268174Hoekstra 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.
PubMed 20202912Riegel 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.
PubMed 21769111Mao 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.
PubMed 25105284Liu 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.
PubMed 22367574
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01416285
- Acronym / sponsor ID
- 98-1154B
- Conditions
- Death, Congestive Heart Failure
- Keywords
- Congestive heart failure (CHF), CHF education, self-care training, CHF center
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jun 2010 (actual)
- Primary completion
- 30 May 2012 (actual)
- Study completion
- 30 May 2012 (actual)
- First posted
- 15 Aug 2011 (estimated)
- Results
- Posted 8 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized due to acute cardiogenic pulmonary edema will be consecutively enrolled in the HF center of Chang Gung Memorial Hospital.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18268174Jaarsma 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.
- Results publication: PubMed 20202912Hoekstra 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.
- Results publication: PubMed 21769111Riegel 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.
- Derived from this study: PubMed 25105284Mao 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.
- Derived from this study: PubMed 22367574Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CHAO-HUNG WANG, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Death and Congestive Heart Failure, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01416285, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.