Role of heart-reactive antibodies in heart failure
| ISRCTN | ISRCTN18181364 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18181364 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 123 |
| Sponsor | University Hospital Würzburg |
| Funder | German Research Foundation (DFG) within the Comprehensive Research Center 1525 'Cardio-immune interfaces' (453989101, project C5) |
- 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
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
Public, Scientific, Principal investigator
Am Schwarzenberg 15
Würzburg
97080
Germany
 ORCID ID |
0000-0002-0920-6094 |
|---|---|
| Phone | +49 (0)15757923778 |
| Morbach_C@ukw.de |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective cohort study |
| Secondary study design | Cohort study |
| Study type | 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(s) |
Death or hospitalization for heart failure (HF) in the 18 months following the hospitalization for acute heart failure (AHF), taken from medical records |
| Key secondary outcome measure(s) |
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 |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 110 Years |
| Sex | All |
| Target sample size at registration | 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
Würzburg
97078
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
06/02/2025: Study's existence confirmed by the Medizinische Ethikkommission an der Julius-Maximilians-Universität Würzburg.
