Disease manifestation and disease management in chronic heart failure
| ISRCTN | ISRCTN23325295 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23325295 |
| Secondary identifying numbers | N/A |
- Submission date
- 21/09/2005
- Registration date
- 30/11/2005
- Last edited
- 29/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Heart failure is frequent, increasing in prevalence, and is associated with high morbidity, mortality and costs. In order to reduce morbidity (illness) and mortality (death rate) in high-risk patients who have already experienced an episode of acute cardiac decompensation, appropriate comprehensive monitoring and collaborative treatment are of key importance. Unlike in other chronic diseases (e.g. diabetes mellitus) there is limited availability of comprehensive heart failure disease management within the German Health Care System, and targeted interventions considering patients individual risk profiles and their changes over time are lacking. This study compares a structured nurse-coordinated collaborative disease management intervention with usual care. HeartNet-Care-HF™ was developed in Germany for post-inpatient care and includes as modules monitoring, information, self-empowerment, improvement of compliance with pharmacotherapy, suitable discharge management and networking amongst a patients different health care providers.
Who can participate?
Patients hospitalized with decompensated systolic heart failure are eligible, if aged ≥18 years and able to participate in a telephone-based intervention.
What does the study involve?
Patients will be randomly allocated to one of the two study groups: HeartNet-Care-HF™ or usual care. Patients undergoing usual care receive standard post-discharge management, which typically includes a discharge letter with recommendations for increasing the dose (up-titration) of heart failure drugs and lifestyle modifications, and an appointment with a general practitioner or cardiologist within 14 days of discharge from hospital. While still hospitalized, patients undergoing HeartNet-Care-HF™ are, in addition, trained by a specialized nurse in self-control of blood pressure, heart rate and rhythm, body weight and recognition of worsening heart failure. Nurses also ascertain that patients have body scales and blood pressure gauges at home, dispense written information on heart failure drugs and materials supporting documentation of self-monitoring results, and plan subsequent telephone-based monitoring with the patients (weekly in the first month post discharge, then according to NYHA class and patients needs). Up-titration of guideline-recommended heart failure medication is an explicit goal of the intervention and pursued in collaboration with the patients general practitioner and/or cardiologist.
What are the possible benefits and risks of participation?
There are no risks or disadvantages of participating in the usual care group of the study, which offers heart failure treatment according to current standards. Patients in the HeartNet-Care-HF™ group receive holistic collaborative care and monitoring. The hypothesis of the study is that this treatment will improve clinical end-points as the long-term risk of mortality and re-hospitalization, reduce heart failure symptoms and lead to better quality of life. However, these hypotheses are not yet proven, and patients will have to comply with the study protocol in HeartNet-Care-HF™, which involves regular communication with the nurse and self-supervision. In summary, participation in the HeartNet-Care-HF™ group is associated with no risks, but a potential long-term benefit at the expense of some time.
Where is the study run from?
The study is coordinated by Profs. C. E. Angermann, G. Ertl and Prof. S. Störk at the Comprehensive Heart Failure Center (CHFC) at the University Hospital in Würzburg, Germany. In addition to two departments of the University Hospital, seven regional non-academic hospitals enrolled patients into the study.
When is the study starting and how long is it expected to run for?
The study started in March 2004, recruitment lasted 4 years, the study treatment was terminated after 18 months participation of each individual patient, and follow-up will continue until December 2019.
Who is funding the study?
The study is funded by the Federal Ministry of Education and Research (Germany) as part of the Competence Network Heart Failure, the Comprehensive Heart Failure Center Würzburg and by the Central Association of German Health Insurance Companies.
Who is the main contact?
Prof. Dr. med. C. Angermann
Prof. Dr. med. S. Störk
Contact information
Scientific
Comprehensive Heart Failure Centre
Am Schwarzenberg 15
Würzburg
97078
Germany
 ORCID ID |
0000-0001-7491-7637 |
|---|---|
| Phone | +49 (0)931 201 46361 |
| angermann_c@ukw.de |
Study information
| Study design | Two-arm parallel-group prospective randomised controlled intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A standardised multidisciplinary disease management programme improves mortality and morbidity in patients with systolic heart failure - the Interdisciplinary Network Heart failure (INH) Study |
| Study acronym | INH-Study/E-INH Study |
| Study objectives | Current hypotheses as of 15/01/2021: INH-Study: Network care (HeartNet-Care-HF™) when compared to usual care reduces mortality and hospitalisation (combined primary endpoint) and/or improves quality of life 6 months after randomisation. Extended INH-Study: Network care (HeartNet-Care-HF™) when compared to usual care reduces mortality and hospitalisation (combined primary endpoint) 18 months after randomisation. Beneficial effects on the primary and secondary endpoints (e.g. quality of life) are sustainable beyond termination of the study intervention. _____ Previous hypothesis: Network care when compared to usual care reduces mortality and hospitalisation (combined primary end point) and/or improves quality of life 6 months after randomisation. |
| Ethics approval(s) | Approved 09/01/2004, Ethics Committee of the Faculty of Medicine, University of Würzburg (Ethik-Kommission der Medizinischen Fakultät der Universität Würzburg), ref: 130/03 Amendment 01 approved on 19/07/2007 Amendment 02 approved on 12/08/2013 Amendment 03 approved on 14/08/2014 to extend follow-up to 120 months |
| Health condition(s) or problem(s) studied | Chronic heart failure |
| Intervention | Current intervention as of 25/01/2021: The Interdisciplinary Network Heart Failure (INH) study was a two-arm parallel group randomised intervention study. Patients were randomised 1:1 into network care and usual care. Intensified patient care and management (i.e. network care) was characterised by: 1. Patient self-monitoring plus telephone-based symptom-oriented monitoring following a predefined algorithm depending on the severity of the condition. 2. Telephone-based patient-oriented education and training regarding self-care, heart failure manifestation, medications, lifestyle, psychological dimensions. 3. The intervention was performed by specialised heart failure nurses who are supervised by a physician heart failure specialist. The INH study reported that a 6-month, structured remote patient management (RPM) intervention (HeartNetCare-HF™) did not reduce the composite primary outcome of time to all-cause death or all-cause hospitalisation in patients discharged from hospital after acute decompensation for systolic HF compared with usual care (UC); however, quality of life improved and all-cause mortality risk was significantly reduced in the RPM group. The Extended (E)-INH study aimed to enroll a larger population to determine the effects of using the well-defined HeartNetCare-HF™ RPM strategy for 18 months on the same primary outcome, other morbidity- and mortality-related events, and patient-reported outcomes following discharge after hospitalization for acute heart failure. Efficacy was compared between an initial 6-month period of more intense RPM and the subsequent 12 months, during which less intense RPM was applied. Sustainability was assessed during prolonged prospective follow-up after RPM termination. _____ Previous intervention as of 15/01/2021: This is a two-arm parallel group randomised intervention study. Patients are randomised 1:1 into network care and usual care. Intensified patient care and management (i.e. network care) is characterised by: 1. Patient self-monitoring plus telephone-based symptom-oriented monitoring following a predefined algorithm depending on the severity of the condition. 2. Telephone-based patient-oriented education and training regarding self-care, heart failure manifestation, medications, lifestyle, psychological dimensions. 3. The intervention is performed by specialised heart failure nurses who are supervised by a physician heart failure specialist. _____ Previous intervention as of 29/12/2020: This is a two-arm parallel group randomised intervention study. Patients are randomised 1:1 into network care and usual care. Intensified patient care and management (i.e. network care) is characterised by: 1. Telephone-based symptom-oriented patient monitoring following a predefined algorithm depending on the severity of the condition 2. Telephone-based patient-oriented education and training regarding heart failure manifestation, diet, psychological dimensions Patients will be followed up for 120 months. _____ Previous intervention: This is a two-arm parallel group randomised intervention study. Patients are randomised 1:1 into network care and usual care. Intensified patient care and management (i.e. network care) is characterised by: 1. Telephone-based symptom-oriented patient monitoring following a predefined algorithm depending on the severity of the condition 2. Telephone-based patient-oriented education and training regarding heart failure manifestation, diet, psychological dimensions |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measure as of 20/08/2009: 1. Death of any cause or hospitalisation of any cause (combined endpoint) Previous primary outcome measures: 1. Death of any cause or hospitalisation of any cause (combined endpoint) 2. Quality of life |
| Secondary outcome measures | Current secondary outcome measures as of 29/12/2020: 1. Components of composite primary endpoint 2. Quality of life 3. Cardiovascular death 4. Cardiovascular hospitalisation 5. Proportion of patients treated in adherence with current heart failure treatment guidelines 6. Cost-effectiveness analyses _____ Previous secondary outcome measures as of 20/08/2009: 1. Components of composite primary endpoint 2. Cardiovascular death 3. Cardiovascular hospitalisation 4. Proportion of patients treated in adherence with current heart failure treatment guidelines 2. Quality of life 5. Cost-effectiveness analyses _____ Previous secondary outcome measures: 1. Components of composite primary endpoint 2. Cardiovascular death 3. Cardiovascular hospitalisation 4. Proportion of patients treated in adherence with current heart failure treatment guidelines 5. Cost-effectiveness analyses |
| Overall study start date | 01/03/2004 |
| Completion date | 10/10/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1,022 |
| Total final enrolment | 1032 |
| Key inclusion criteria | 1. Age >18 years 2. Written informed consent 3. Heart failure documented by reduced left ventricular ejection fraction (<=40%) during hospitalisation and clinical signs/symptoms of heart failure (peripheral edema, pulmonary edema, rales, pulmonary congestion confirmed by X-ray, elevated jugular venous pressure, exertional dyspnea) |
| Key exclusion criteria | 1. Insufficient mental or verbal or physical ability to participate in a telephone assisted monitoring and education program 2. No telephone line installed |
| Date of first enrolment | 01/03/2004 |
| Date of final enrolment | 10/12/2008 |
Locations
Countries of recruitment
- Germany
Study participating centre
97078
Germany
Sponsor information
University/education
Sanderring 2
Würzburg
97070
Germany
| Phone | +49 (0)931 31 2231 |
|---|---|
| kanzler@zv.uni-wuerzburg.de | |
| Website | https://www.uni-wuerzburg.de/startseite/ |
"ROR" |
https://ror.org/00fbnyb24 |
Funders
Funder type
Government
No information available
No information available
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 01/07/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The INH data have been published in 2012. The E-INH data will first be presented at the annual Spring Meeting of the German Cardiac Society, which will take place 7 – 10 April 2021. The manuscript will be submitted by end of February. |
| IPD sharing plan | As the researchers will perform several pre-specified secondary analyses, they do not plan to make the database available before these have been published. They will, as was the case in the past regarding the 6-month data set, make data from the database available for scientists (e.g., for reviews and meta-analyses) upon reasonable request, on which the INH coordinators will, together with the principal/corresponding author of the 120-month primary publication, decide in an individualized fashion. The primary 120-month manuscript will contain a respective statement. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | publication (in German) on the interventions used in this study | 01/04/2009 | Yes | No | |
| Results article | INH results | 01/01/2012 | Yes | No | |
| Other publications | secondary analysis of participants with subclinical thyroid dysfunction | 20/09/2013 | Yes | No | |
| Other publications | secondary analysis of PHQ-2 and PHQ-9 and correlation with death or rehospitalisation | 01/05/2015 | Yes | No | |
| Other publications | secondary analysis of participants hospitalised for systolic heart failure | 01/01/2019 | 27/02/2020 | Yes | No |
| Other publications | secondary analysis of mortality reduction in depressed and non-depressed participants | 01/10/2014 | 21/12/2020 | Yes | No |
| Other publications | secondary analysis of prescribing | 01/04/2015 | 21/12/2020 | Yes | No |
| Other publications | secondary analysis of prognostic value of depressive symptoms | 01/06/2015 | 21/12/2020 | Yes | No |
| Other publications | secondary analysis on dysnatraemia | 01/10/2012 | 21/12/2020 | Yes | No |
| Other publications | secondary analysis of association of NPSR1 gene variants with death, rehospitalisation and healthcare utilisation | 01/03/2017 | 15/01/2021 | Yes | No |
| Other publications | secondary analysis of associations between CRP genetic variants, mortality and depression | 01/07/2018 | 15/01/2021 | Yes | No |
| Other publications | secondary analysis of prognostic potential of midregional pro-adrenomedullin (MR-proADM) | 01/09/2017 | 15/01/2021 | Yes | No |
| Other publications | secondary analysis of salivary cortisol levels | 15/01/2016 | 15/01/2021 | Yes | No |
| Other publications | secondary analysis of sex and gender differences in PHQ-9 and HRQOL responses | 01/03/2019 | 15/01/2021 | Yes | No |
| Other publications | secondary analysis of prevalence of major and minor depression | 17/02/2011 | 25/01/2021 | Yes | No |
| Other publications | secondary analysis of LVEF trajectories after acute cardiac decompensation of heart failure | 02/02/2021 | 27/01/2021 | Yes | No |
Editorial Notes
29/01/2021: Internal review.
27/01/2021: Publication reference added.
25/01/2021: The following changes have been made:
1. The intervention has been updated to clarify the original INH study and the extension E-INH.
2. The acronym has been updated to include the E-INH study.
3. The publication and dissemination plan has been updated to reflect that results of the INH study have already ben published.
4. Publication reference added.
15/01/2021: The following changes have been made:
1. The study hypothesis has been updated.
2. The intervention has been updated.
3. Publication references added.
4. The publication list has been updated to clarify the type of data in each reference.
5. The plain English summary has been updated to clarify where the study was run from.
29/12/2020: The following changes have been made:
1. The trial website url has been removed.
2. The scientific contact's details have been updated.
3. The scientific title has been changed from "A standardised multidisciplinary disease management programme improves mortality and morbidity in patients with systolic heart failure - the Interdisciplinary Network for Heart failure (INH) Study" to "A standardised multidisciplinary disease management programme improves mortality and morbidity in patients with systolic heart failure - the Interdisciplinary Network Heart failure (INH) Study".
4. The update notes in the study hypothesis were moved into the editorial notes.
5. The ethics approval has been updated to reflect the 2014 amendment.
6. The intervention has been updated.
7. The study design has been changed from "Two-arm parallel-group randomised intervention study" to "Two-arm parallel-group prospective randomised controlled intervention study ".
8. The overall trial end date has been changed from the predicted overall trial end date of 31/12/2019 to the actual overall trial end date of 10/10/2018.
9. The recruitment end date has been changed from the predicted overall trial end date of 31/03/2008 to the actual recruitment end date of 10/12/2008.
10. The trial participating centre wording has been changed from "9 regional hospitals including Juliusspital, Würzburg" to "Nine trial sites, including two medical departments of University Hospital Würzburg plus 7 regional hospitals".
11. The sponsor website has been added.
12. The German Government, Competence Network Heart Failure and Comprehensive Heart Failure Center Würzburg have been added as funders.
13. The plain English summary has been updated to reflect the above changes.
21/12/2020: Publication and dissemination plan, intention to publish date, IPD sharing statement, publication references added.
27/02/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the 2013 reference.
01/08/2017: recruitment end date corrected from 31/12/2019 to 31/03/2008.
17/04/2014: The following changes were made to the trial record:
1. The follow-up period was extended to 36 and 60 months
2. The anticipated end date was changed from 30/09/2009 to 31/12/2019
3. The target number of participants was changed from 1,000 to 1,022
20/08/2009: The following changes were made to the trial record:
1. Scientific title was added
2. Target number of participants was changed from 700 to 1,000
3. Trial end date was updated from 31/12/2006 to 30/09/2009
4. Randomised intervention extended to 18 months
5. All other changes are recorded in the relevant fields.
