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Behavioural Intervention

Neuromodulation for Heart Failure (TREAT-HF Trial)

N/A
Recruiting
Led By Tarun Dasari, MD,MPH
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients admitted with ADHF
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from admission to discharge- over average 3-6 days
Awards & highlights

TREAT-HF Trial Summary

This trial will study the effects of low-level tragus nerve stimulation on inflammatory cytokines in patients with acute decompensated heart failure.

Who is the study for?
This trial is for patients admitted with Acute Decompensated Heart Failure (ADHF). It's not suitable for those who refuse consent, have complex heart conditions like Tetralogy of Fallot, history of frequent fainting due to low heart rate or blood pressure, major nerve surgery in the neck, severe heartbeat irregularities, are pregnant or imprisoned, and those with advanced kidney disease or certain infections like Hepatitis C or HIV.Check my eligibility
What is being tested?
The study tests if Low Level Tragus Stimulation (LLTS), a non-invasive technique that affects nerve activity related to the heart can reduce inflammation markers in the blood and improve symptoms such as difficulty breathing. Participants will be randomly assigned to receive either real LLTS or a sham treatment daily during their hospital stay.See study design
What are the potential side effects?
Since LLTS is non-invasive and involves stimulating nerves on the outer ear, side effects might include local discomfort at the stimulation site. However, because it influences nervous system activity related to heart function there may be risks of affecting heart rhythm.

TREAT-HF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was admitted to the hospital for acute decompensated heart failure.

TREAT-HF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from admission to discharge- over average 3-6 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and from admission to discharge- over average 3-6 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in CRP levels
Change in Interleukin (IL) levels
Change in Pro BNP and renal function(creatinine) levels
+1 more
Secondary outcome measures
Change in HRV
Other outcome measures
Change in level of dyspnea

TREAT-HF Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Tragus StimulationExperimental Treatment1 Intervention
In this group patients will receive neuromodulation for 2 hours daily
Group II: Control groupActive Control1 Intervention
Sham neuromodulation will be done
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neuromodulation
2022
Completed Phase 4
~70

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
455 Previous Clinical Trials
97,510 Total Patients Enrolled
4 Trials studying Heart Failure
267 Patients Enrolled for Heart Failure
Tarun Dasari, MD,MPHPrincipal InvestigatorOUHSC
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Heart Failure
50 Patients Enrolled for Heart Failure

Media Library

Tragus Stimulation (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT02898181 — N/A
Heart Failure Research Study Groups: Tragus Stimulation, Control group
Heart Failure Clinical Trial 2023: Tragus Stimulation Highlights & Side Effects. Trial Name: NCT02898181 — N/A
Tragus Stimulation (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02898181 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do the requirements of this trial extend to individuals younger than thirty-five?

"This research requires participants to be within the age range of 18-75. For those under 18, there are 22 trials available and for seniors over 65 years old, 693 studies can be found."

Answered by AI

Would you be able to provide information on whether this experiment is currently enrolling participants?

"The public record of clinicaltrials.gov shows that this study is actively seeking participants, beginning on September 1st 2016 and most recently updated on December 16th 2021."

Answered by AI

How many individuals are enrolled in this experimental research?

"Indeed, the information provided on clinicaltrials.gov shows that this research is actively enrolling participants. This study was originally proposed on September 1st 2016 and has since been updated as recently as December 16th 2021. 80 patients will be welcomed at a single site to partake in this trial."

Answered by AI

Are the requirements needed to join this medical examination within my reach?

"To take part in this medical trial, applicants must have a diagnosis of heart failure and be between 18-75 years old. 80 people are being invited to join the study."

Answered by AI
~4 spots leftby Sep 2024