Chronic Heart FailureCOETAVNCT06950320
Clinical Outcome of Electrical Transcutaneous Auricular Vagal Stimulation in Patients With Stable Symptomatic Chronic Heart Failure
A study testing P-STIM (Biegler, Mauerbach, Austria) is a battery-operated micro-stimulation appliance in people with Chronic Heart Failure, run by Medical University of Vienna at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- P-STIM (Biegler, Mauerbach, Austria) is a battery-operated micro-stimulation appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jan 2014to 31 Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic heart failure
- NYHA Classification II-III
- Stable medication since at least 1 months
- LVEF <40%
- Patients must be able to understand study conditions
- No exclusion criteria
Show all 13Show fewer
- Signed informed consent 6.1.3 Exclusion criteria
- Any electrical auricular vagal stimulation treatment within 6 months prior to base line visit
- Participation in another clinical trial within 3 months prior to base line visit
- Ventricular tachyarrhythmia within 1 month prior to base line visit
- Psoriasis vulgaris
- Hemophilia
- Cardiac pace makers
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcome of Electrical Auricular Vagal Stimulation in Patients With Stable Symptomatic Chronic Heart Failure
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.
Read more
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.
- Conditions
- Chronic Heart Failure
- Being tested
- P-STIM (Biegler, Mauerbach, Austria) is a battery-operated micro-stimulation appliance, Placebo
- Keywords
- auricular vagal stimulation, chronic heart failure, 6-minute walking test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-STIM (Biegler, Mauerbach, Austria) is a battery-operated micro-stimulation applianceDevice
P-STIM (Biegler, Mauerbach, Austria) is a battery-operated micro-stimulation appliance weighing 5 grams, designed as a disposable product for a single use. P-STIM is placed behind the patient's ear and connected to stimulation needles (usually 3 needles) on the auricle. For the study, only one stimulation needle was needed. P-STIMTM offers regular therapy over several days. The appliance transmits low frequency electric pulses to exposed nerve endings. The built-in microchip creates periods of stimulation and rest, each lasting approximately 3 hours. Stimulation was performed with a frequency of 1Hz for 40min followed by a break of 20 min.
PlaceboDevice
The placebo device is a look-a-like, that stimulates only for 1h hour and then stops.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients received a placebo device which was a look-a-like, that stimulated only for 1h hour and then stopped. Patients in both groups were told that they will not feel the stimulation after a while, which might contribute to a better blinding between the groups. Receives: Device: Placebo |
| treatment group | Active comparator | P-STIM (Biegler, Mauerbach, Austria) is a battery-operated micro-stimulation appliance weighing 5 grams, designed as a disposable product for a single use. P-STIM is placed behind the patient's ear and connected to stimulation needles (usually 3 needles) on the auricle. For the study, only one stimulation needle was needed. P-STIM offers regular therapy over several days. The appliance transmits low frequency electric pulses to exposed nerve endings. The built-in microchip creates periods of stimulation and rest, each lasting approximately 3 hours. Stimulation was performed with a frequency of 1Hz for 40min followed by a break of 20 min. After some time, the patient may feel as if the intensity of stimulation is decreasing. A decrease in the perceived intensity of stimulation may however be subjective and have no bearing on the effectiveness of the therapy. Receives: Device: P-STIM (Biegler, Mauerbach, Austria) is a battery-operated micro-stimulation appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minutes walking distance test
patients were asked to walk at comfortable speed for 6min in one of our hospital corridors (30m long), distance was assessed by a physician
Measured: before treatment randomization, study day 21, 35 days after randomization
Secondary outcomes (10)
SF 36, quality of life
The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures.
The possible score ranges from 0 to 100 points whereby 0 points represent the greatest possible limitation of health, while 100 points represent the absence of health restrictions.
Measured: before treatment randomization, 35 days after treatment randomization
adverse events
An AE/ADE is any adverse change from the subject's baseline condition, i.e. any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease which is considered to be clinically relevant be the physician that occurs during the course of the, whether or not considered related to the medical device.
Adverse event /ADE include:
- Exacerbation of a pre-existing disease.
- Increase in frequency or intensity of a pre-existing episodic disease or medical condition.
- Disease or medical condition detected or diagnosed after treatment with the medical device even though it may have been present prior to the start of the clinical investigation.
- Continuous persistent disease or symptoms present at baseline that worsen following the start of the clinical investigation.
- Lack of efficacy in the acute treatment of a life-threatening disease.
- Events considered by the investigator to be related to clinical investigation-mandated procedures.
Measured: before treatment randomization, study day 21, 35 days after randomization
blood concentration of TNF alpha
blood samples will be collected before treatment randomization and at end of study, measurement will be in picogram/millilitre
Measured: before treatment randomization, 35 days after treatment randomization
blood concentration of Interleucin 6 (IL6)
blood samples will be collected, measurement will be in nanogram/litre
Measured: before treatment randomization, 35 days after treatment randomization
blood concentration of C-reactive protein (CRP)
blood samples will be collected, measurement will be in milligram/decilitre
Measured: before treatment randomization, 35 days after treatment randomization
blood concentration of NT-proBNP
blood samples will be collected, measurement will be in picogram/mililitre
Measured: before treatment randomization, 35 days after treatment randomization
left ventricular ejection fraction
left ventricular ejection fraction will be assessed by an experienced cardiologist via echocardiography and will be expressed as percentage of a normal value
Measured: before treatment randomization, 35 days after treatment randomization
NYHA
New York Heart Association Classification, will be expressed in 4 stages Class I (Mild) No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath). Class II (Mild) Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea. Class III (Moderate) Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV (Severe) Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased.
Measured: before treatment randomization, 35 days after treatment randomization
blood pressure
blood pressure will be assessed non-invasively by a cardiologist and will be expressed as millimeter mercury
Measured: before treatment randomization, 35 days after treatment randomization
ST-elevation
will be detected via electrocardiogram which was performed by a cardiologist
Measured: before treatment randomization, 35 days after treatment randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start1 Jan 2014
- Primary completion31 Jan 2016
- Study completion31 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Regina Patricia Schukro, Medical University of Vienna
- Investigators
- Sabine Sator, MD, Professor, Study director, Medical University of Vienna, Dept. of Pain TherapyRegina Patricia Schukro, MD, Principal investigator, Medical University of Vienna, Dept. of Anaesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950320
- Sponsor's protocol ID
- EK-No: 2033/2012
- Other IDs
- 2033/2012
- Acronym
- COETAV
- Status last verified
- Apr 2025
- First submitted
- 27 Feb 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zijlstra FJ, van den Berg-de Lange I, Huygen FJ, Klein J. Anti-inflammatory actions of acupuncture. Mediators Inflamm. 2003 Apr;12(2):59-69. doi: 10.1080/0962935031000114943.
PubMed 12775355Schneider A, Streitberger K, Joos S. Acupuncture treatment in gastrointestinal diseases: a systematic review. World J Gastroenterol. 2007 Jul 7;13(25):3417-24. doi: 10.3748/wjg.v13.i25.3417.
PubMed 17659687Schwartz PJ, De Ferrari GM, Sanzo A, Landolina M, Rordorf R, Raineri C, Campana C, Revera M, Ajmone-Marsan N, Tavazzi L, Odero A. Long term vagal stimulation in patients with advanced heart failure: first experience in man. Eur J Heart Fail. 2008 Sep;10(9):884-91. doi: 10.1016/j.ejheart.2008.07.016. Epub 2008 Aug 28.
PubMed 18760668Kristen AV, Schuhmacher B, Strych K, Lossnitzer D, Friederich HC, Hilbel T, Haass M, Katus HA, Schneider A, Streitberger KM, Backs J. Acupuncture improves exercise tolerance of patients with heart failure: a placebo-controlled pilot study. Heart. 2010 Sep;96(17):1396-400. doi: 10.1136/hrt.2009.187930. Epub 2010 Jun 15.
PubMed 20554511Coats AJ. The "muscle hypothesis" of chronic heart failure. J Mol Cell Cardiol. 1996 Nov;28(11):2255-62. doi: 10.1006/jmcc.1996.0218.
PubMed 8938579Anand IS, Latini R, Florea VG, Kuskowski MA, Rector T, Masson S, Signorini S, Mocarelli P, Hester A, Glazer R, Cohn JN; Val-HeFT Investigators. C-reactive protein in heart failure: prognostic value and the effect of valsartan. Circulation. 2005 Sep 6;112(10):1428-34. doi: 10.1161/CIRCULATIONAHA.104.508465. Epub 2005 Aug 29.
PubMed 16129801Lainchbury JG, Troughton RW, Strangman KM, Frampton CM, Pilbrow A, Yandle TG, Hamid AK, Nicholls MG, Richards AM. N-terminal pro-B-type natriuretic peptide-guided treatment for chronic heart failure: results from the BATTLESCARRED (NT-proBNP-Assisted Treatment To Lessen Serial Cardiac Readmissions and Death) trial. J Am Coll Cardiol. 2009 Dec 29;55(1):53-60. doi: 10.1016/j.jacc.2009.02.095.
PubMed 20117364Mann DL. Inflammatory mediators and the failing heart: past, present, and the foreseeable future. Circ Res. 2002 Nov 29;91(11):988-98. doi: 10.1161/01.res.0000043825.01705.1b.
PubMed 12456484Lecour S, James RW. When are pro-inflammatory cytokines SAFE in heart failure? Eur Heart J. 2011 Mar;32(6):680-5. doi: 10.1093/eurheartj/ehq484. Epub 2011 Feb 7.
PubMed 21303780Gullestad L, Ueland T, Vinge LE, Finsen A, Yndestad A, Aukrust P. Inflammatory cytokines in heart failure: mediators and markers. Cardiology. 2012;122(1):23-35. doi: 10.1159/000338166. Epub 2012 Jun 12.
PubMed 22699305Pomerantz BJ, Reznikov LL, Harken AH, Dinarello CA. Inhibition of caspase 1 reduces human myocardial ischemic dysfunction via inhibition of IL-18 and IL-1beta. Proc Natl Acad Sci U S A. 2001 Feb 27;98(5):2871-6. doi: 10.1073/pnas.041611398.
PubMed 11226333Kapadia SR. Cytokines and heart failure. Cardiol Rev. 1999 Jul-Aug;7(4):196-206. doi: 10.1097/00045415-199907000-00011.
PubMed 10423671Damas JK, Gullestad L, Ueland T, Solum NO, Simonsen S, Froland SS, Aukrust P. CXC-chemokines, a new group of cytokines in congestive heart failure--possible role of platelets and monocytes. Cardiovasc Res. 2000 Jan 14;45(2):428-36. doi: 10.1016/s0008-6363(99)00262-x.
PubMed 10728363Aukrust P, Ueland T, Muller F, Andreassen AK, Nordoy I, Aas H, Kjekshus J, Simonsen S, Froland SS, Gullestad L. Elevated circulating levels of C-C chemokines in patients with congestive heart failure. Circulation. 1998 Mar 31;97(12):1136-43. doi: 10.1161/01.cir.97.12.1136.
PubMed 9537339Torre-Amione G, Kapadia S, Benedict C, Oral H, Young JB, Mann DL. Proinflammatory cytokine levels in patients with depressed left ventricular ejection fraction: a report from the Studies of Left Ventricular Dysfunction (SOLVD). J Am Coll Cardiol. 1996 Apr;27(5):1201-6. doi: 10.1016/0735-1097(95)00589-7.
PubMed 8609343
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Electrical Auricular Vagal Stimulation in Patients With Stable Symptomatic Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT06950320
- Acronym / sponsor ID
- COETAV / EK-No: 2033/2012
- Conditions
- Chronic Heart Failure
- Keywords
- auricular vagal stimulation, chronic heart failure, 6-minute walking test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Jan 2016 (actual)
- Study completion
- 31 Jan 2016 (actual)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Device: PlaceboPatients received a placebo device which was a look-a-like, that stimulated only for 1h hour and then stopped. Patients in both groups were told that they will not feel the stimulation after a while, which might contribute to a better blinding between the groups. |
| treatment group | Active comparator | Device: P-STIM (Biegler, Mauerbach, Austria) is a battery-operated micro-stimulation applianceP-STIM (Biegler, Mauerbach, Austria) is a battery-operated micro-stimulation appliance weighing 5 grams, designed as a disposable product for a single use. P-STIM is placed behind the patient's ear and connected to stimulation needles (usually 3 needles) on the auricle. For the study, only one stimulation needle was needed. P-STIM offers regular therapy over several days. The appliance transmits low frequency electric pulses to exposed nerve endings. The built-in microchip creates periods of stimulation and rest, each lasting approximately 3 hours. Stimulation was performed with a frequency of 1Hz for 40min followed by a break of 20 min. After some time, the patient may feel as if the intensity of stimulation is decreasing. A decrease in the perceived intensity of stimulation may however be subjective and have no bearing on the effectiveness of the therapy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Chronic heart failure
- NYHA Classification II-III
- Stable medication since at least 1 months
- LVEF <40%
- Patients must be able to understand study conditions
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P-STIM (Biegler, Mauerbach, Austria) is a battery-operated micro-stimulation applianceP-STIM (Biegler, Mauerbach, Austria) is a battery-operated micro-stimulation appliance weighing 5 grams, designed as a disposable product for a single use. P-STIM is placed behind the patient's ear and connected to stimulation needles (usually 3 needles) on the auricle. For the study, only one stimulation needle was needed. P-STIMTM offers regular therapy over several days. The appliance transmits low frequency electric pulses to exposed nerve endings. The built-in microchip creates periods of stimulation and rest, each lasting approximately 3 hours. Stimulation was performed with a frequency of 1Hz for 40min followed by a break of 20 min. | Device | treatment group |
| PlaceboThe placebo device is a look-a-like, that stimulates only for 1h hour and then stops. | Device | Placebo |
Primary outcome
6-minutes walking distance test
Time frame: before treatment randomization, study day 21, 35 days after randomization
patients were asked to walk at comfortable speed for 6min in one of our hospital corridors (30m long), distance was assessed by a physician
10 secondary outcomes
SF 36, quality of life
Time frame: before treatment randomization, 35 days after treatment randomization
adverse events
Time frame: before treatment randomization, study day 21, 35 days after randomization
blood concentration of TNF alpha
Time frame: before treatment randomization, 35 days after treatment randomization
blood concentration of Interleucin 6 (IL6)
Time frame: before treatment randomization, 35 days after treatment randomization
blood concentration of C-reactive protein (CRP)
Time frame: before treatment randomization, 35 days after treatment randomization
blood concentration of NT-proBNP
Time frame: before treatment randomization, 35 days after treatment randomization
left ventricular ejection fraction
Time frame: before treatment randomization, 35 days after treatment randomization
NYHA
Time frame: before treatment randomization, 35 days after treatment randomization
blood pressure
Time frame: before treatment randomization, 35 days after treatment randomization
ST-elevation
Time frame: before treatment randomization, 35 days after treatment randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Background: PubMed 12775355Zijlstra FJ, van den Berg-de Lange I, Huygen FJ, Klein J. Anti-inflammatory actions of acupuncture. Mediators Inflamm. 2003 Apr;12(2):59-69. doi: 10.1080/0962935031000114943.
- Background: PubMed 17659687Schneider A, Streitberger K, Joos S. Acupuncture treatment in gastrointestinal diseases: a systematic review. World J Gastroenterol. 2007 Jul 7;13(25):3417-24. doi: 10.3748/wjg.v13.i25.3417.
- Background: PubMed 18760668Schwartz PJ, De Ferrari GM, Sanzo A, Landolina M, Rordorf R, Raineri C, Campana C, Revera M, Ajmone-Marsan N, Tavazzi L, Odero A. Long term vagal stimulation in patients with advanced heart failure: first experience in man. Eur J Heart Fail. 2008 Sep;10(9):884-91. doi: 10.1016/j.ejheart.2008.07.016. Epub 2008 Aug 28.
- Background: PubMed 20554511Kristen AV, Schuhmacher B, Strych K, Lossnitzer D, Friederich HC, Hilbel T, Haass M, Katus HA, Schneider A, Streitberger KM, Backs J. Acupuncture improves exercise tolerance of patients with heart failure: a placebo-controlled pilot study. Heart. 2010 Sep;96(17):1396-400. doi: 10.1136/hrt.2009.187930. Epub 2010 Jun 15.
- Background: PubMed 8938579Coats AJ. The "muscle hypothesis" of chronic heart failure. J Mol Cell Cardiol. 1996 Nov;28(11):2255-62. doi: 10.1006/jmcc.1996.0218.
- Background: PubMed 16129801Anand IS, Latini R, Florea VG, Kuskowski MA, Rector T, Masson S, Signorini S, Mocarelli P, Hester A, Glazer R, Cohn JN; Val-HeFT Investigators. C-reactive protein in heart failure: prognostic value and the effect of valsartan. Circulation. 2005 Sep 6;112(10):1428-34. doi: 10.1161/CIRCULATIONAHA.104.508465. Epub 2005 Aug 29.
- Background: PubMed 20117364Lainchbury JG, Troughton RW, Strangman KM, Frampton CM, Pilbrow A, Yandle TG, Hamid AK, Nicholls MG, Richards AM. N-terminal pro-B-type natriuretic peptide-guided treatment for chronic heart failure: results from the BATTLESCARRED (NT-proBNP-Assisted Treatment To Lessen Serial Cardiac Readmissions and Death) trial. J Am Coll Cardiol. 2009 Dec 29;55(1):53-60. doi: 10.1016/j.jacc.2009.02.095.
- Background: PubMed 12456484Mann DL. Inflammatory mediators and the failing heart: past, present, and the foreseeable future. Circ Res. 2002 Nov 29;91(11):988-98. doi: 10.1161/01.res.0000043825.01705.1b.
- Background: PubMed 21303780Lecour S, James RW. When are pro-inflammatory cytokines SAFE in heart failure? Eur Heart J. 2011 Mar;32(6):680-5. doi: 10.1093/eurheartj/ehq484. Epub 2011 Feb 7.
- Background: PubMed 22699305Gullestad L, Ueland T, Vinge LE, Finsen A, Yndestad A, Aukrust P. Inflammatory cytokines in heart failure: mediators and markers. Cardiology. 2012;122(1):23-35. doi: 10.1159/000338166. Epub 2012 Jun 12.
- Background: PubMed 11226333Pomerantz BJ, Reznikov LL, Harken AH, Dinarello CA. Inhibition of caspase 1 reduces human myocardial ischemic dysfunction via inhibition of IL-18 and IL-1beta. Proc Natl Acad Sci U S A. 2001 Feb 27;98(5):2871-6. doi: 10.1073/pnas.041611398.
- Background: PubMed 10423671Kapadia SR. Cytokines and heart failure. Cardiol Rev. 1999 Jul-Aug;7(4):196-206. doi: 10.1097/00045415-199907000-00011.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine Sator, MD, Professor study director
Medical University of Vienna, Dept. of Pain Therapy
Regina Patricia Schukro, MD principal investigator
Medical University of Vienna, Dept. of Anaesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P-STIM (Biegler, Mauerbach, Austria) is a battery-operated micro-stimulation appliance in people with Chronic Heart Failure, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minutes walking distance test (time frame: before treatment randomization, study day 21, 35 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06950320, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.