Role of heart-reactive antibodies in heart failure

ISRCTN	ISRCTN18181364
DOI	https://doi.org/10.1186/ISRCTN18181364
Secondary identifying numbers	123

Submission date: 06/02/2025
Registration date: 07/02/2025
Last edited: 07/02/2025

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
An acute heart failure (AHF) episode may boost an adaptive immune response against myocardial antigens that contributes to the progression of heart failure and poor prognosis. This study will address the following research questions:
1. What are the prevalence and determinants of anti-myocardial autoantibodies (pan-anti-heart, antigen-specific) and auto-reactive T cells in AHF patients?
2. What are the characteristics and determinants of the adaptive immune response to an AHF episode?
3. What is the expression of auto-antibodies over time?
4. Is the adaptive immune response following AHF associated with the progression of cardiac impairment and the prognosis of AHF patients?

Who can participate?
Patients aged 18 years and over who are hospitalized at the University Hospital Würzburg for acute heart failure

What does the study involve?
Detailed clinical, echocardiographic and immunologic assessment at the start of the study as well as 6 weeks and 6, 12, and 18 months after hospitalization.

What are the possible benefits and risks of participating?
Since this study is purely descriptive and standard medical care will not be affected, there are no study-specific risks for patients. This study will help to further strengthen the structures for collaborative HF care. By providing optimal management opportunities this structured approach will likely benefit also individual study participants.

Where is the study run from?
Dpt. Clinical Research and Epidemiology, Comprehensive Heart Failure Center Würzburg & Dpt. Medicine I, University Hospital Würzburg (Germany)

When is the study starting and how long is it expected to run for?
April 2021 to December 2026

Who is funding the study?
The study is funded by the German Research Foundation via the SFB1525, project C05

Who is the main contact?
1. Dr Caroline Morbach, morbach_c@ukw.de
2. Dr Niklas Beyersdorf, niklas.beyersdorf@uni-wuerzburg.de

Contact information

Mrs Caroline Morbach
Public, Scientific, Principal Investigator

Am Schwarzenberg 15
Würzburg
97080
Germany

ORCID ID	0000-0002-0920-6094
Phone	+49 (0)15757923778
Email	Morbach_C@ukw.de

Study information

Study design	Prospective cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details to request a participant information sheet
Scientific title	Acute Heart Failure Immunomonitoring Cohort Study (AHF-ImmunoCS)
Study acronym	AHF-ImmunoCS
Study objectives	The overarching hypothesis is that an acute heart failure (AHF) episode boosts an adaptive immune response against myocardial antigens that contributes to the progression of heart failure and consecutively to poor prognosis.
Ethics approval(s)	Approved 28/06/2021, Medizinische Ethikkommission an der Julius-Maximilians-Universität Würzburg (Josef-Schneider-Str. 4, C15, Würzburg, 97080, Germany; +49 (0)931 31 48315; ethikkommission@uni-wuerzburg.de), ref: 112/21
Health condition(s) or problem(s) studied	Acute heart failure
Intervention	Patients hospitalized for acute heart failure will be followed for 18 months. From blood drawn at baseline, 6 weeks and 6 months after decompensation, the researchers will assess the incidence of heart-reactive antibodies. They will associate these results to an 18-month prognosis.
Intervention type	Other
Primary outcome measure	Death or hospitalization for heart failure (HF) in the 18 months following the hospitalization for acute heart failure (AHF), taken from medical records
Secondary outcome measures	1. Cytokine profile, inflammation markers (CRP, IL-6 and other cytokines) in the acute intrahospital phase and at 6 weeks (F6w), 6 months (F6), 12 months (F12) and 18 months (F18) after hospitalization for AHF 2. Adaptive immune response pattern (heart-reactive antibodies) at F6w, F6, F12 and F18: cellular immunophenotypes, anti-myocardial antibody titres and quality, frequencies and differentiation of heart-reactive T cells 3. Cardiac structure and function (echocardiography: LV volume, LVEF, e´) at F6w, F6, F12, and F18 4. Heart failure severity (NYHA, NT-proBNP, 6-min walking distance) at F6w, F6, F12, and F18 5. Hospitalization (for worsening HF and all-cause, respectively) at F6, F12 and F18, taken from medical records 6. Death (cardiac and all-cause, respectively) at F6, F12 and F18, taken from medical records
Overall study start date	08/04/2021
Completion date	31/12/2026

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	110 Years
Sex	Both
Target number of participants	381
Key inclusion criteria	1. Hospitalization for AHF (consecutive patients, Dept. of Internal Medicine I) 2. Age ≥18 years 3. Written informed consent 4. Willingness to attend planned follow-up visits at the Comprehensive Heart Failure Center (CHFC) 5. Life expectancy ≥6 months
Key exclusion criteria	1. High urgency listing for heart transplant 2. High output failure 3. Left ventricular assist device (LVAD) implanted/planned
Date of first enrolment	01/02/2022
Date of final enrolment	31/03/2025

Locations

Countries of recruitment

Germany

Study participating centre

University Hospital Würzburg

Oberdürrbacher Str. 6
Würzburg
97078
Germany

Sponsor information

University Hospital Würzburg
Hospital/treatment centre

Am Schwarzenberg 15
Würzburg
97080
Germany

Phone	+49 (0)931 201 46248
Email	dzhi@ukw.de
Website	https://www.ukw.de

Funders

Funder type

Research organisation

German Research Foundation (DFG) within the Comprehensive Research Center 1525 'Cardio-immune interfaces' (453989101, project C5)

No information available

Results and Publications

Intention to publish date	31/05/2025
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Design and first results - submitted
IPD sharing plan	The datasets generated and analysed during the current study can be made available upon request from Caroline Morbach (Morbach_C@ukw.de).

Editorial Notes

06/02/2025: Study's existence confirmed by the Medizinische Ethikkommission an der Julius-Maximilians-Universität Würzburg.