Acute heart failure-voice
| ISRCTN | ISRCTN13093083 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13093083 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 16SV8877 |
| Sponsor | University Hospital Würrzburg |
| Funder | Bundesministerium für Bildung und Forschung |
- Submission date
- 12/02/2025
- Registration date
- 03/04/2025
- Last edited
- 07/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
The Acute Heart Failure (AHF)-Voice study aims to explore the relationship between congestion and voice alterations in patients with AHF to see if it reflects their clinical condition. The study will address the following key questions:
1. What are the characteristics and determinants of vocal alterations in patients with AHF?
2. To what extent do these vocal alterations correlate with the patient's clinical status during an AHF episode?
3. To what extent are vocal biomarkers sensitive to changes over time, and how do they compare to established clinical parameters in HF such as quality of life or NT-proBNP levels?
4. Can specific vocal biomarkers or combinations be mapped to different HF phenotypes?
5. Are vocal biomarkers associated with patient prognosis?
6. Are voice alterations in patients with AHF associated with pathophysiological changes, such as vocal fold edema, that affect vocal fold oscillation?
Who can participate?
Patients aged 18 years and over who are hospitalized at the University Hospital Würzburg for AHF
What does the study involve?
Detailed clinical, echocardiographic and voice assessment at baseline, 6 weeks and 6 months after hospitalization.
What are the possible benefits and risks of participating?
By providing optimal management opportunities this structured approach will likely benefit also individual study participants. Since this study is purely descriptive and standard medical care will not be affected, there are no study-specific risks for patients.
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?
February 2022 to July 2025
Who is funding the study?
The study is funded by the German Ministry of Research and Education within the UNISONO Consortium
Who is the main contact?
Dr Fabian Kerwagen, MPH, Kerwagen_F@ukw.de
Contact information
Public, Scientific, Principal investigator
University Hospital Würrzburg
Am Schwarzenberg 15
Würzburg
97080
Germany
 ORCID ID |
0000-0002-6501-7511 |
|---|---|
| Phone | +49-0931-201-46585 |
| Kerwagen_F@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 voice analysis prospective cohort study |
| Study acronym | AHF-Voice |
| Study objectives | The hypothesis is that volume overload and recompensation in patients with AHF are associated with voice alterations reflective of changes in clinical status. |
| Ethics approval(s) |
Approved 16/03/2023, Medical Ethics Committee at the Julius-Maximilians-University Würzburg (Josef-Schneider-Str. 4, C15, Würzburg, 97080, Germany; +49 (0)931 31 48315; ethikkommission@uni-wuerzburg.de), ref: 245/22 |
| Health condition(s) or problem(s) studied | Acute heart failure |
| Intervention | Patients hospitalized for acute heart failure will be followed for 6 months. The trajectory of voice alteration will be tracked through daily voice recordings. Follow-ups will be conducted at 6 weeks and 6 months after decompensation. |
| Intervention type | Other |
| Primary outcome measure(s) | Change of vocal biomarker during an acute heart failure episode at index hospitalization (Baseline), assessed through daily voice recordings |
| Key secondary outcome measure(s) | 1. Change in the vocal biomarker during the 6-month observation period, assessed through daily voice recordings. 2. Type and prevalence of vocal cord dysfunction assessed by video-stroboscopy during an AHF episode (Baseline), 6 weeks (F6w), 6 months (F6m) after hospitalization for AHF 3. Cardiac structure and function, assessed by echocardiography at Baseline, F6w, F6m 4. Heart failure severity (NYHA, NT-proBNP, 6-min walking distance) at Baseline, F6w, F6m 5. Pulmonary function assessed by pulmonary function tests at F6w, F6m 6. Quality of life assessed by questionnaires at Baseline, F6w, and F6m 7. (Re-)Hospitalization (for worsening HF and all-cause, respectively) at F6w and F6m, taken from medical records 8. Death (cardiac and all-cause, respectively) at F6w and F6m, taken from medical records |
| Completion date | 31/07/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 131 |
| Total final enrolment | 131 |
| 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 output heart failure 2. Cardiogenic shock 3. High-urgency listing for heart transplant 4. Left ventricular assist device (LVAD) implanted/planned 5. History of vocal fold disorder or vocal fold surgery |
| Date of first enrolment | 14/04/2023 |
| Date of final enrolment | 03/12/2024 |
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 reasonable request from Fabian Kerwagen, Kerwagen_F@ukw.de. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Interim results article | 02/05/2025 | 07/07/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
07/07/2025: Publication reference added.
14/02/2025: Study's existence confirmed by the Medical Ethics Committee at the Julius-Maximilians-University Würzburg.
