Fabio A Alves
Niterói, CA, 94706, Brazil
NCT Number: NCT03354689
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.
Looking for future studies?
Notify Me21 year–80 year
All sexes
Observational
Niterói, CA, 94706, Brazil
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients with a diagnosis of heart failure, New York Heart Association (NYHA) functional classification between II to III and left ventricular ejection fraction ≤ 50%
Exclusion criteria
Scintigraphy
Time frame: 12 months
This measurement provides a highly reproducible index of cardiac sympathetic activity
Time frame: 12 months
This measurement provides a highly reproducible index of cardiac sympathetic innervation
Time frame: 12 months
This measurement provides a highly reproducible index of muscle sympathetic activity
Universidade Federal Fluminense
Other
Cervicothoracic Transcutaneous Electrical Nerve Stimulation Attenuates Cardiac Sympathetic Overdrive in Heart Failure: A 123l-MIBG Myocardial Scintigraphy, Randomized Double-Blind Crossover Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05835401
Cardiovascular Abnormalities, Cardiovascular Diseases
Ribeirão Preto, São Paulo, Brazil
View Trial DetailsNCT05987891
Cardiovascular Abnormalities, Cardiovascular Diseases
São Paulo, Brazil
View Trial DetailsNCT05196815
Cardiovascular Abnormalities, Cardiovascular Diseases
Wolverhampton, West Midlands, United Kingdom
View Trial DetailsNCT05624255
Cardiovascular Abnormalities, Cardiovascular Diseases
Besançon, France
View Trial Details