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Disease manifestation and disease management in chronic heart failure
ISRCTN ISRCTN23325295
DOI 10.1186/ISRCTN23325295
ClinicalTrials.gov identifier
EudraCT number
Public title Disease manifestation and disease management in chronic heart failure
Scientific title A standardised multidisciplinary disease management programme improves mortality and morbidity in patients with systolic heart failure - the Interdisciplinary Network for Heart failure (INH) Study
Acronym INH-Study
Serial number at source N/A
Study 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.

On 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
All other changes are recorded in the relevant fields.

On 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
Lay summary 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 patientsí 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-HFTM 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 patientís 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-HFTM 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-HFTM 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 patientsí needs). Up-titration of guideline-recommended heart failure medication is an explicit goal of the intervention and pursued in collaboration with the patientsí 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-HFTM 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-HFTM, which involves regular communication with the nurse and self-supervision. In summary, participation in the HeartNet-Care-HFTM 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. Stoerk at the Comprehensive Heart Failure Center (CHFC) at the University Hospital in Würzburg. The following study sites also enrolled patients into the study:
1. Juliusspital, Würzburg
2. Missionsärztliche Klinik, Würzburg
3. Deegenbergklinik, Bad Kissingen
4. Caritas Krankenhaus, Bad Mergentheim
5. Städtisches Krankenhaus, Wertheim
6. Kreiskrankenhaus, Tauberbischofsheim
7. AWO-Klinik, Würzburg

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 and by central associations of statutory health insurance providers.

Who is the main contact?
Prof. Dr. med. C. Angermann (angermann_c@ukw.de)
Prof. Dr. med. S. Stoerk
Ethics approval Ethics Committee of the Faculty of Medicine, University of Würzburg (Ethik-Kommission der Medizinischen Fakultät der Universität Würzburg), approved on 09/01/2004, ref: 130/03
Amendment 01 approved on 19/07/2007
Amendment 02 approved on 12/08/2013
Study design Two-arm parallel-group randomised intervention study
Countries of recruitment Germany
Disease/condition/study domain Chronic heart failure
Participants - 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)
Participants - 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
Anticipated start date 01/03/2004
Anticipated end date 31/12/2019
Status of trial Ongoing
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 1,022
Interventions 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
Primary outcome measure(s) 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 measure(s) Current 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
Sources of funding 1. German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]).
2. Head Organisation of non-private health insurances (Spitzenverbände der gesetzlichen Krankenkassen).

Added on 24/08/2009: Additional funding was received from the German Competence Network Heart Failure for the 'extended INH-Study' in 2006 and 2009.
Trial website http://www.chfc.uk-wuerzburg.de/en/aerzte/studien/inh-studie.html
Publications 2009 publication (in German) on the interventions used in this study in: http://www.ncbi.nlm.nih.gov/pubmed/19340758
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/21956192
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23041000
Contact name Prof  Christiane E  Angermann
  Address Straubmühlweg 2a
  City/town Wuerzburg
  Zip/Postcode 97078
  Country Germany
  Tel +49 (0)931 201 46361
  Fax +49 (0)931 201 646360
  Email angermann_c@ukw.de
Sponsor University of Wuerzburg (Germany)
  Address Sanderring 2
  City/town Wuerzburg
  Zip/Postcode 97070
  Country Germany
  Tel +49 (0)931 31 2231
  Fax +49 (0)931 31 2100
  Email kanzler@zv.uni-wuerzburg.de
Date applied 21/09/2005
Last edited 12/08/2014
Date ISRCTN assigned 30/11/2005
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