Condition category
Circulatory System
Date applied
04/08/2014
Date assigned
16/10/2014
Last edited
16/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Documented information about the outcome of treatments for patients with acute heart failure (AHF) during their stay in hospital and during their follow-up visits is very scarce. Further, no up-to-date data are available on in-patient clinical profiles in the critical stages. Follow-up data are lacking, including documentation of heart function that can help in the understanding of the type and severity of heart failure, modern treatment patterns after a hospitalization for AHF, management of risk factors and associated diseases (e.g. kidney failure or anaemia) and information on type and rates of complications. It is also unknown how many patients after a hospital admission for acute heart failure will, in the long run, develop advanced heart failure. The AHF registry is an initiative of the Comprehensive Heart Failure Center Wuerzburg. It is a forthcoming short- and long-term registry of HF patients, enrolled at the time of hospitalization for AHF, which will help to address the above listed knowledge gaps. The AHF registry will be capable of identifying unmet medical, psychosocial and palliative needs, monitor the impact of new drug-related as well as surgical treatment options for HF, and direct future HF research.

Who can participate?
Adult patients who are hospitalized for acute heart failure.

What does the study involve?
The study involves a complete data collection during the hospital stay and regular follow-up visits up to 5 years to assess the patients' health status. This registry is necessary to document the natural history of AHF, and associated long-term HF treatment patterns including re-hospitalization rates, specific treatment patterns for certain risk factors and other diseases that can be associated with HF, clinical outcomes, quality of life (QoL), brain function, depression and standardized evaluation of palliative requirements. This 'real world' data collection study will not interfere with the usual care of patients, and will not lead to specific diagnostic procedures or treatments. Study data will be collected during routine visits.

What are the possible benefits and risks of participating?
Patients might benefit from regular examinations; however, there is no immediate benefit. The results of the data collection in the registry might in future contribute to a better diagnosis and treatment of acute heart failure. There are no risks to participating.

Where is the study run from?
University Hospital in Wuerzburg, Germany.

When is the study starting and how long is it expected to run for?
August 2014 until August 2020.

Who is funding the study?
The Federal Ministry of Education and Research (Germany).

Who is the main contact?
Prof. Dr med. C. Angermann
angermann_c@ukw.de

Trial website

http://www.chfc.ukw.de/en/research/project-areas/project-area-g.html

Contact information

Type

Scientific

Primary contact

Prof Christiane E Angermann

ORCID ID

Contact details

Straubmühlweg 2a
Wuerzburg
97078
Germany
angermann_c@ukw.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Prospective cohort study on etiology, clinical Features, costs, palliative needs and outcomes in acute heart failure

Acronym

AHF Registry Würzburg

Study hypothesis

1. Analyses of the data will significantly improve the pathophysiological knowledge about AHF and in particular about the early phase after cardiac decompensation, worsening, progressive and advanced HF. Further, it will provide by prospective assessment of treatment efficacy a rational basis for future differential treatment allocation in patients with AHF and advanced HF considering also HF etiology and course.
2. Since consecutive patients will be recruited on a 7 day/24 hour basis, a representative profile of the various etiologies and clinical representations of AHF will for the first time be generated in the frame of the German healthcare system.
3. Data generated from this study can be used to better define significant prognostic characteristics and guide short-term management and maintenance treatment decisions.
4. With this study it will be possible to identify so far unmet needs of the participants.
5. Data generated from the study will allow monitoring the impact of novel pharmacological and surgical HF treatment options on the clinical short- and long-term course and direct future HF research.
6. Systematic longitudinal characterization of the clinical profile of advanced HF patients including documentation of outcome data in relation to applied treatment modalities will generate reliable information on the natural course of the disease as well as on the short- and long-term effects of specific pharmacological, interventional and surgical procedures in these 'real life' patients beyond the data available from randomized clinical trials.

Ethics approval

Ethics Committee of the University of Wuerzburg, July 2014, ref. 55/14

Study design

Prospective cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Acute heart failure

Intervention

There is no intervention in this study. The data collection for the AHF Registry Würzburg does not interfere with any routine diagnostic or therapeutic procedures. There are no additional study-related examinations or procedures.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Incidence of post-discharge events (re-hospitalization and cause-specific death) during the observation period

Secondary outcome measures

1. Proportion of patients with HFrEF versus HFpEF at the time of the index hospitalization
2. Proportion of patients with HFrEF versus HFpEF versus other aetiologies including reversible HF (e.g. arrhythmogenic) at the time of discharge from hospital after the index hospitalization
3. Proportion of patients with de novo versus decompensated chronic HF at the index hospitalization
4. Frequency of diagnosis of different HF etiologies at the time of index hospitalization
5. Time course of re-hospitalization events (all-cause and HF-related, duration of hospital stays and time intervals between consecutive re-hospitalization events) and incidence of cause-specific death after the index hospitalization
6. Time alive and out of hospital
7. Prevalence of advanced HF at index hospitalization
8. Incidence of advanced HF during follow-up
9. Clinical course and outcomes of patients with advanced HF according to different treatment patterns (e.g. surgical versus medical only)
10. Incidence of the transition from HFrEF to HFpEF and vice versa during long-term follow-up
11. Prevalence, severity and correlates of anxiety, depression, cognitive impairment, and impairment of quality of life during the index hospitalization and during long-term follow-up
12. Differential impact of co-morbidities on short-term and long-term outcomes

Overall trial start date

01/08/2014

Overall trial end date

31/08/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age >18 years
2. Hospitalization with AHF (de novo/decompensated chronic HF) according to the clinical judgment of the responsible physician
3. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1000

Participant exclusion criteria

1. Cardiogenic shock
2. High output heart failure
3. On waiting list for urgent HTX

Recruitment start date

01/08/2014

Recruitment end date

31/08/2020

Locations

Countries of recruitment

Germany

Trial participating centre

Straubmühlweg 2a
Wuerzburg
97078
Germany

Sponsor information

Organisation

University of Würzburg (Universitätsklinikum Würzburg) (Germany)

Sponsor details

Josef-Schneider-Str. 2
Wuerzburg
97080
Germany
Angermann_C@ukw.de

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

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

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

Publication citations

Additional files

Editorial Notes