Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-01-09 @ 5:08 PM
Study NCT ID:
NCT06950320
Status:
COMPLETED
Last Update Posted:
2025-04-30
First Post:
2025-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcome of Electrical Transcutaneous Auricular Vagal Stimulation in Patients With Stable Symptomatic Chronic Heart Failure
Sponsor:
Medical University of Vienna
Organization:
Study Overview
Official Title:
Clinical Outcome of Electrical Auricular Vagal Stimulation in Patients With Stable Symptomatic Chronic Heart Failure
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COETAV
Brief Summary:
This study aims to investigate whether electrical vagus nerve stimulation in the auricle has an impact on the clinical presentation of heart failure. The device used, P-STIM, is already successfully applied in pain therapy and angiology (peripheral arterial disease, PAD) and will also be tested against a placebo in this study.
In preliminary studies, acupuncture was shown to improve the 6-minute walking distance in heart failure patients (Kristen et al., 2010). The investigators assume that acupuncture and P-STIM have similar effects, and this study also aims to improve the 6-minute walking distance as its primary endpoint. Additional endpoints include LVEF (left ventricular ejection fraction), NYHA classification, inflammatory markers (e.g., CRP, pro-BNP), and patients' quality of life.
Study Design:
Patients will be randomly assigned to either the placebo or the verum group. They will receive treatment for five weeks (with the device being replaced weekly) and undergo a follow-up examination after four weeks.
At the beginning and during follow-up, Left ventricular ejection fraction (measured by cardiac ultrasound), inflammatory markers in the blood, NYHA classification, and quality of life (assessed by questionnaire) will be recorded. The primary endpoint, the 6-minute walking distance, will be measured at baseline, two weeks after the start of treatment, and at the follow-up examination.
In preliminary studies, acupuncture was shown to improve the 6-minute walking distance in heart failure patients (Kristen et al., 2010). The investigators assume that acupuncture and P-STIM have similar effects, and this study also aims to improve the 6-minute walking distance as its primary endpoint. Additional endpoints include LVEF (left ventricular ejection fraction), NYHA classification, inflammatory markers (e.g., CRP, pro-BNP), and patients' quality of life.
Study Design:
Patients will be randomly assigned to either the placebo or the verum group. They will receive treatment for five weeks (with the device being replaced weekly) and undergo a follow-up examination after four weeks.
At the beginning and during follow-up, Left ventricular ejection fraction (measured by cardiac ultrasound), inflammatory markers in the blood, NYHA classification, and quality of life (assessed by questionnaire) will be recorded. The primary endpoint, the 6-minute walking distance, will be measured at baseline, two weeks after the start of treatment, and at the follow-up examination.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2033/2012 | REGISTRY | Ethics commitee Medical University of Vienna | View |