Condition category
Circulatory System
Date applied
21/09/2005
Date assigned
30/11/2005
Last edited
22/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English 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 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-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 patient’s 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 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-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

Trial website

http://www.chfc.uk-wuerzburg.de/en/aerzte/studien/inh-studie.html

Contact information

Type

Scientific

Primary contact

Prof Christiane E Angermann

ORCID ID

Contact details

Straubmühlweg 2a
Wuerzburg
97078
Germany
+49 (0)931 201 46361
angermann_c@ukw.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

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

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic heart failure

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 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 trial start date

01/03/2004

Overall trial end date

31/12/2019

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1,022

Participant 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

Recruitment start date

01/03/2004

Recruitment end date

31/12/2019

Locations

Countries of recruitment

Germany

Trial participating centre

Straubmühlweg 2a
Wuerzburg
97078
Germany

Sponsor information

Organisation

University of Wuerzburg (Germany)

Sponsor details

Sanderring 2
Wuerzburg
97070
Germany
+49 (0)931 31 2231
kanzler@zv.uni-wuerzburg.de

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]).

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Head Organisation of non-private health insurances (Spitzenverbände der gesetzlichen Krankenkassen).

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25878325

Publication citations

  1. Results

    Angermann CE, Störk S, Gelbrich G, Faller H, Jahns R, Frantz S, Loeffler M, Ertl G, , Mode of action and effects of standardized collaborative disease management on mortality and morbidity in patients with systolic heart failure: the Interdisciplinary Network for Heart Failure (INH) study., Circ Heart Fail, 2012, 5, 1, 25-35, doi: 10.1161/CIRCHEARTFAILURE.111.962969.

  2. Results

    Frey A, Kroiss M, Berliner D, Seifert M, Allolio B, Güder G, Ertl G, Angermann CE, Störk S, Fassnacht M, Prognostic impact of subclinical thyroid dysfunction in heart failure., Int. J. Cardiol., 2013, 168, 1, 300-305, doi: 10.1016/j.ijcard.2012.09.064.

  3. Störk S, Faller H, Schowalter M, Ertl G, Angermann CE, [Evidence-based disease management in patients with heart failure (HeartNetCare-HF Würzburg)]., Dtsch. Med. Wochenschr., 2009, 134, 15, 773-776, doi: 10.1055/s-0029-1220230.

  4. Results

    Piepenburg SM, Faller H, Gelbrich G, Störk S, Warrings B, Ertl G, Angermann CE, Comparative Potential of the Two- Versus the Nine-Item Patient Health Questionnaire to Predict Death or Re-Hospitalization in Heart Failure, Circ Heart Fail, 2015, doi: 10.1161/CIRCHEARTFAILURE.114.001488 .

Additional files

Editorial Notes