Heart FailurePhase 4NCT02692690
TENS in Optimizer(R) Patients
A Phase 4 study testing Stimulette r4x in people with Heart Failure, run by Medical University of Vienna.
Trial summary
Systemic skeletal muscle atrophy (cachexia) is a typical side effect of chronic heart failure. Patients with cachexia can benefit from transcutaneous electrical neuromuscular stimulation (TENS). It is applied to strengthen the musculature and improve exercise tolerance and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Heart Failure
- What is being tested?
- Stimulette r4x
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Oct 2015
- Phase
- Phase 4
- 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 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years, with implantation of the Optimizer ® >6 months ago, clinically stable condition and without any ventricular arrhythmic episode in the last 3 months.
Who cannot join
- Local swelling or edema at the site of stimulation, intolerance to electrical stimulation, or presence of other metallic implants at the site of stimulation
About this study
Official title: Electromagnetic Interference by Transcutaneous Neuromuscular Electrical Stimulation in Patients With Optimizer(R) - a Pilot Safety Study
Systemic skeletal muscle atrophy (cachexia) is a typical side effect of chronic heart failure.
Patients with cachexia can benefit from transcutaneous electrical neuromuscular stimulation (TENS). It is applied to strengthen the musculature and improve exercise tolerance and quality of life.
Read more
It is unclear if application of TENS can cause electromagnetic interference (EMI) in patients with Optimizer® pacemaker systems for improvement of heart failure.
This pilot safety study enrolled 6 patients with chronic heart failure and reduced left ventricular ejection fraction. All patients had an Optimizer® pacemaker system implanted for a minimum of 6 months, no patients had any ventricular arrhythmic episode 3 months prior to the study, and all were in clinically stable condition and willing to participate in this study.
Neuromuscular stimulation was administered via TENS in 4 different modes (HF, LF, Burst, MF) on the right and left musculus trapezius and on both musculi quadriceps femoris. All patients were tested for EMI without or with cardiac contractility modulation (CCM) delivery of the Optimizer®-system respectively.
- Conditions
- Heart Failure
- Being tested
- Stimulette r4x
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulette r4xDevice
| Study group | Role | What they receive |
|---|---|---|
| before-after | Experimental | TENS stimulation neck and thigh Receives: Device: Stimulette r4x |
What is being measured
The primary outcome is the main question the study is designed to answer.
The patients with CCM-system are assessed for EMI during TENS-application
Electromagnetic interference can cause artificial sensing in pacemaker or ICD system. These artefacts may have the effect of suppressing the pacemaker pulses sensing of tachycardia in ICD.
The patients will be exposed to electrical stimulations, which will be of different forces on the neck and the upper thigh with r4x. These impulses and the effects will be noted down. It will be investigated if there is an interference with the optimizer ® depending on the different sites of the electrical stimulations and the different impulse forces.
Many patients with an Optimizer ® have simultaneously a pacemaker - or ICD implant. A special extra monitor will note if there are probable interferences with these pacemaker- or ICD implants.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startMay 2015
- Primary completionAug 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Wolzt, Prof. MD, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692690
- Sponsor's protocol ID
- 1067_2015
- Status last verified
- Feb 2016
- First submitted
- 28 Jan 2016
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromagnetic Interference by Transcutaneous Neuromuscular Electrical Stimulation in Patients With Optimizer(R) - a Pilot Safety Study
- ClinicalTrials.gov ID
- NCT02692690
- Acronym / sponsor ID
- 1067_2015
- Conditions
- Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 26 Feb 2016 (estimated)
- 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.
Systemic skeletal muscle atrophy (cachexia) is a typical side effect of chronic heart failure.
Patients with cachexia can benefit from transcutaneous electrical neuromuscular stimulation (TENS). It is applied to strengthen the musculature and improve exercise tolerance and quality of life.
It is unclear if application of TENS can cause electromagnetic interference (EMI) in patients with Optimizer® pacemaker systems for improvement of heart failure.
This pilot safety study enrolled 6 patients with chronic heart failure and reduced left ventricular ejection fraction. All patients had an Optimizer® pacemaker system implanted for a minimum of 6 months, no patients had any ventricular arrhythmic episode 3 months prior to the study, and all were in clinically stable condition and willing to participate in this study.
Neuromuscular stimulation was administered via TENS in 4 different modes (HF, LF, Burst, MF) on the right and left musculus trapezius and on both musculi quadriceps femoris. All patients were tested for EMI without or with cardiac contractility modulation (CCM) delivery of the Optimizer®-system respectively.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| before-after | Experimental | Device: Stimulette r4xTENS stimulation neck and thigh |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- >18 years, with implantation of the Optimizer ® >6 months ago, clinically stable condition and without any ventricular arrhythmic episode in the last 3 months.
Key exclusion criteria (1 listed)
- Local swelling or edema at the site of stimulation, intolerance to electrical stimulation, or presence of other metallic implants at the site of stimulation
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 |
|---|---|---|
| Stimulette r4x | Device | before-after |
Primary outcome
The patients with CCM-system are assessed for EMI during TENS-application
Time frame: 6 months
Electromagnetic interference can cause artificial sensing in pacemaker or ICD system. These artefacts may have the effect of suppressing the pacemaker pulses sensing of tachycardia in ICD. The patients will be exposed to electrical stimulations, which will be of different forces on the neck and the upper thigh with r4x. These impulses and the effects will be noted down. It will be investigated if there is an interference with the optimizer ® depending on the different sites of the electrical stimulations and the different impulse forces. Many patients with an Optimizer ® have simultaneously a pacemaker - or ICD implant. A special extra monitor will note if there are probable interferences with these pacemaker- or ICD implants.
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 26 Feb 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stimulette r4x in people with Heart Failure, run by Medical University of Vienna.
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 1 inclusion and 1 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 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The patients with CCM-system are assessed for EMI during TENS-application (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2016.