Heart Failure, DiastolicNERDDNCT02983448
Noninvasive Neuromodulation to Reserve Diastolic Dysfunction
A study testing transcutaneous vagus nerve stimulation in people with Heart Failure, Diastolic, run by University of Oklahoma at 1 site in United States.
Trial summary
This is a 2x2 cross over pilot study using low level transcutaneous vagus nerve stimulation (LLTS) to reverse diastolic dysfunction in patients with diastolic dysfunction. All patients will receive 2 separate, 1-hour sequences, at least 1 day apart, of active and sham LLTS, but the sequence will be randomized. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure, Diastolic
- What is being tested?
- transcutaneous vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients older than 18 year old
- Evidence of diastolic dysfunction on echocardiogram within 24 months of study enrollment
Who cannot join
- Left ventricular dysfunction (Left ventricular ejection fraction <40%)
- Significant valvular disorder (i.e., prosthetic valve or hemodynamically relevant valvular diseases)
- Recent (<6 months) stroke or myocardial infarction
- Severe heart failure (NYHA class III or IV)
- Recurrent vaso-vagal syncopal episodes
- Unilateral or bilateral vagotomy
- Pregnancy or breast feeding
- Sick sinus syndrome (without a pacemaker), 2nd or 3rd degree AV block, bifascicular block or prolonged (PR>300ms) 1st degree AV block
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
This is a 2x2 cross over pilot study using low level transcutaneous vagus nerve stimulation (LLTS) to reverse diastolic dysfunction in patients with diastolic dysfunction. All patients will receive 2 separate, 1-hour sequences, at least 1 day apart, of active and sham LLTS, but the sequence will be randomized. Patients will be randomly assigned (1:1) to active/sham or sham/active LLTS. LLTS will be performed using a transcutaneous electrical nerve stimulation (TENS) device with electrodes attached to the tragus of the ear, which is innervated by auricular branch of the vagus nerve. Echocardiography will be performed after 30 minutes of LLTS or sham stimulation to assess diastolic function. Five-minute ECGs will be obtained for HRV analysis every 15 minutes of stimulation (total of 4 recordings).
- Conditions
- Heart Failure, Diastolic
- Being tested
- transcutaneous vagus nerve stimulation
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous vagus nerve stimulationDevice
All patients will receive both active and sham transcutaneous vagus nerve stimulation, with the order being randomized
| Study group | Role | What they receive |
|---|---|---|
| Sham stimulation first | Placebo comparator | Sham stimulation delivered at the earlobe (devoid of vagal innervation) is given on first session.
Transcutaneous vagus nerve stimulation delivered at the tragus (vagal innervation) is given on second session. Receives: Device: transcutaneous vagus nerve stimulation |
| Active stimulation first | Active comparator | Transcutaneous vagus nerve stimulation delivered at the earlobe (vagal innervation) is given on first session.
Sham stimulation delivered at the tragus (devoid of vagal innervation) is given on second session. Receives: Device: transcutaneous vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiographic Markers of Diastolic Dysfunction
Global longitudinal strain
Measured: after 1 hour of stimulation
Secondary outcomes (1)
Heart Rate Variability Measures
low frequency to high frequency ratio. This is a measure of sympathovagal balance. A lower value reflects a more favorable balance between sympathetic and parasympathetic (vagal) tone.
Measured: after 1 hour of stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionMar 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, DiastolicStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stavros Stavrakis, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983448
- Sponsor's protocol ID
- IRB-7147
- Acronym
- NERDD
- Status last verified
- Jun 2019
- First submitted
- 30 Nov 2016
- Last updated
- 25 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Tran N, Asad Z, Elkholey K, Scherlag BJ, Po SS, Stavrakis S. Autonomic Neuromodulation Acutely Ameliorates Left Ventricular Strain in Humans. J Cardiovasc Transl Res. 2019 Jun;12(3):221-230. doi: 10.1007/s12265-018-9853-6. Epub 2018 Dec 17.
PubMed 30560316
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Neuromodulation to Reserve Diastolic Dysfunction
- ClinicalTrials.gov ID
- NCT02983448
- Acronym / sponsor ID
- NERDD / IRB-7147
- Conditions
- Heart Failure, Diastolic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Posted 11 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 2x2 cross over pilot study using low level transcutaneous vagus nerve stimulation (LLTS) to reverse diastolic dysfunction in patients with diastolic dysfunction. All patients will receive 2 separate, 1-hour sequences, at least 1 day apart, of active and sham LLTS, but the sequence will be randomized. Patients will be randomly assigned (1:1) to active/sham or sham/active LLTS. LLTS will be performed using a transcutaneous electrical nerve stimulation (TENS) device with electrodes attached to the tragus of the ear, which is innervated by auricular branch of the vagus nerve. Echocardiography will be performed after 30 minutes of LLTS or sham stimulation to assess diastolic function. Five-minute ECGs will be obtained for HRV analysis every 15 minutes of stimulation (total of 4 recordings).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham stimulation first | Placebo comparator | Device: transcutaneous vagus nerve stimulationSham stimulation delivered at the earlobe (devoid of vagal innervation) is given on first session. Transcutaneous vagus nerve stimulation delivered at the tragus (vagal innervation) is given on second session. |
| Active stimulation first | Active comparator | Device: transcutaneous vagus nerve stimulationTranscutaneous vagus nerve stimulation delivered at the earlobe (vagal innervation) is given on first session. Sham stimulation delivered at the tragus (devoid of vagal innervation) is given on second session. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female patients older than 18 year old
- Evidence of diastolic dysfunction on echocardiogram within 24 months of study enrollment
Key exclusion criteria (8 listed)
- Left ventricular dysfunction (Left ventricular ejection fraction <40%)
- Significant valvular disorder (i.e., prosthetic valve or hemodynamically relevant valvular diseases)
- Recent (<6 months) stroke or myocardial infarction
- Severe heart failure (NYHA class III or IV)
- Recurrent vaso-vagal syncopal episodes
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 |
|---|---|---|
| transcutaneous vagus nerve stimulationAll patients will receive both active and sham transcutaneous vagus nerve stimulation, with the order being randomized | Device | Active stimulation first, Sham stimulation first |
Primary outcome
Echocardiographic Markers of Diastolic Dysfunction
Time frame: after 1 hour of stimulation
Global longitudinal strain
1 secondary outcome
Heart Rate Variability Measures
Time frame: after 1 hour of stimulation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30560316Tran N, Asad Z, Elkholey K, Scherlag BJ, Po SS, Stavrakis S. Autonomic Neuromodulation Acutely Ameliorates Left Ventricular Strain in Humans. J Cardiovasc Transl Res. 2019 Jun;12(3):221-230. doi: 10.1007/s12265-018-9853-6. Epub 2018 Dec 17.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous vagus nerve stimulation in people with Heart Failure, Diastolic, run by University of Oklahoma at 1 site in United States.
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 2 inclusion and 8 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 25 Jun 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 11 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Echocardiographic Markers of Diastolic Dysfunction (time frame: after 1 hour of stimulation). 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 NCT02983448, which also lists 1 linked publication.
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 25 Jun 2019.