RECRUITING

Neuromodulation of Inflammation and Endothelial Function

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Heart failure with reduced ejection fraction (HFrEF) is a major cause of mortality in United States. Aging is a major risk factor for adverse outcomes associated with HFrEF, with majority of the patient's over the age of 50, continuing to experience symptoms, reduced exercise capacity and poor quality of life. We have previously demonstrated that low level transcutaneous electrical stimulation of the vagus nerve at the tragus (LLTS) suppresses inflammation in patients with atrial fibrillation and diastolic dysfunction and improved endothelial dysfunction in patients with chronic heart failure. The overall objective of this proposal is to examine the effects of LLTS on heart failure symptoms, exercise capacity and quality of life in patients with HFrEF and simultaneously determine the impact of LLTS on the suppression of inflammation and improvement in endothelial function. Our specific aims include: 1. To examine the medium term effect of intermittent (1 hour daily for 3 months) LLTS on exercise capacity and quality of life, related to sham stimulation, in patients with HFrEF, 2. To determine the effects of medium-term LLTS on sympathovagal/autonomic balance (assessed by heart rate variability) and systemic inflammation in patients with HFrEF and 3. To determine the effects of medium-term LLTS on endothelial function in patients with HFrEF. The proposed proof-of-concept human studies will provide the basis for the design of further human studies using LLTS among larger populations with HFrEF. In light of the increasing number of elderly patients who continue to experience HFrEF symptoms, recognized is a key point of interest in this funding mechanism, and the suboptimal success of the currently available treatment options to ameliorate the problems mentioned above, an alternative novel approach such as LLTS has the potential to impact clinical practice and improve health outcomes among the large number of patients. It is anticipated that these investigations will contribute to a broader understanding of the role of autonomic imbalance, inflammation and endothelial dysfunction in the pathogenesis of HFrEF and how its inhibition can be used to provide therapeutic effects. Moreover, it is anticipated that a better understanding of how modulation of autonomic tone, inflammation and endothelial function affects one of the hallmarks of HFrEF will lead to the development of normal nonpharmacological and pharmacological approaches to treat this disease.

Official Title

Neuromodulation of Inflammation and Endothelial Function to Treat Elderly Patients With Systolic Heart Failure

Quick Facts

Study Start:2022-09-01
Study Completion:2024-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05230732

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. patients in overt congestive heart failure / recent acute myocardial infarction (\< 4 weeks) or Unstable angina
  2. 2. Active malignancy
  3. 3. unilateral or bilateral vagotomy
  4. 4. pregnant patients
  5. 5. End stage liver disease
  6. 6. history of recurrent vasovagal syncope, Sick sinus syndrome with no pacemaker, 2nd or 3rd degree AV block.
  7. 7. Significant hypotension (Blood pressure \< 90 mm Hg) secondary to autonomic dysfunction

Contacts and Locations

Study Contact

Tarun Dasari, MD,MPH
CONTACT
4052714742
tdasari@ouhsc.edu
Cheryl Adams, RN
CONTACT
4052714742
cheryl-adams@ouhsc.edu

Principal Investigator

Tarun Dasari, MD, MPH
PRINCIPAL_INVESTIGATOR
University of Oklahoma

Study Locations (Sites)

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73117
United States

Collaborators and Investigators

Sponsor: University of Oklahoma

  • Tarun Dasari, MD, MPH, PRINCIPAL_INVESTIGATOR, University of Oklahoma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-01
Study Completion Date2024-10

Study Record Updates

Study Start Date2022-09-01
Study Completion Date2024-10

Terms related to this study

Additional Relevant MeSH Terms

  • Systolic Heart Failure