Transcutaneous Electrical Nerve Stimulation and Cardiac Sympathetic Overdrive in Heart Failure

NCT03354689 | Completed

• 1 other identifier: 39141414.5.0000.5243
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Cardiac sympathetic drive provides inotropic support to the failing heart and preserves cardiovascular homeostasis. Nonetheless, as myocardial insult evolves, this compensatory response leads to a progressive decline in contractile function, increases the vulnerability to arrhythmias and constitutes an independent mortality predictor. Despite advanced pharmacological therapies, side effects and persistent cardiac sympathetic overdrive highlights the modulation of the adrenergic system as a primary target for non-pharmacological strategies in the heart failure (HF) treatment. In this scenario, we will propose cervicothoracic transcutaneous electrical nerve stimulation (TENS) as a non-pharmacological therapy to attenuate cardiac sympathetic overdrive in patients with heart failure. Methods: In this prospective, randomized, sham-controlled, double-blind crossover trial, ten (10) HF patients under optimal pharmacological treatment will be randomly assigned to either an in-home cervicothoracic transcutaneous electrical nerve stimulation therapy (TENS: 30 min twice a day with 80 Hz frequency and pulse duration of 150 μs) or a sham control intervention (SHCI) for two weeks. Following a two-month washout phase from TENS/SHCI, patients crossed over and started the opposite condition. Washout rate and heart-to-mediastinum ratio (planar 123l-metaiodobenzylguanidine myocardial scintigraphy images), indexes of cardiac sympathetic activity and innervation density, muscle sympathetic nerve activity (microneurography) and brachial artery blood flow (Doppler ultrasound) during dynamic handgrip exercise will be obtained at the beginning and end of each condition.

Conditions

Cardiovascular Abnormalities

Outcome Measures

Primary Outcomes (3)

• 123-MIBG Washout rate

  This measurement provides a highly reproducible index of cardiac sympathetic activity

  12 months

• 123-MIBG heart-to-mediastinum ratio

  This measurement provides a highly reproducible index of cardiac sympathetic innervation

  12 months

• Muscle Sympathetic nerve activity

  This measurement provides a highly reproducible index of muscle sympathetic activity

  12 months

Interventions

Scintigraphy RADIATION

Scintigraphy

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with heart failure

You may qualify if:

• Patients with a diagnosis of heart failure, New York Heart Association (NYHA) functional classification between II to III and left ventricular ejection fraction ≤ 50%

You may not qualify if:

• Regular physical activity, pregnancy, unstable angina, acute myocardial infarction in the last 6 months, pacemaker, history of chronic kidney disease (on dialysis) and cardiac surgery.

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Fabio A Alves

Niterói, CA, 94706, Brazil

Location

Related Publications (1)

• Campos MO, Nobrega ACL, Miranda SM, Ribeiro ML, Guerra TRB, Braghirolli AMS, Mesquita CT, Fernandes IA. Transcutaneous electrical nerve stimulation attenuates cardiac sympathetic drive in heart failure: a 123MIBG myocardial scintigraphy randomized controlled trial. Am J Physiol Heart Circ Physiol. 2019 Aug 1;317(2):H226-H233. doi: 10.1152/ajpheart.00091.2019. Epub 2019 May 31.

  PMID: 31149841 DERIVED

MeSH Terms

Conditions

Cardiovascular Abnormalities

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Doctoral Fellow

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 28, 2017
• Study Start: March 20, 2017
• Primary Completion: September 19, 2018
• Study Completion: October 20, 2018
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)