Cardiovascular Abnormalities Clinical Trial
Official title:
Cervicothoracic Transcutaneous Electrical Nerve Stimulation Attenuates Cardiac Sympathetic Overdrive in Heart Failure: A 123l-MIBG Myocardial Scintigraphy, Randomized Double-Blind Crossover Trial
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Suspended |
NCT05542238 -
The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury
|
N/A | |
Active, not recruiting |
NCT02973126 -
Heartflow (AFFECTS)
|
Phase 3 | |
Withdrawn |
NCT00844935 -
Electrocardiographic Autonomic Function Measures in Mechanically Ventilated Patients
|
N/A | |
Completed |
NCT01410487 -
Effects of Weight Loss on Cardio-respiratory Function
|
N/A | |
Withdrawn |
NCT00807274 -
Renal Function in Adults With Congenital Heart Disease.
|
N/A | |
Withdrawn |
NCT00468702 -
Postoperative Canadian Oral Anticoagulation Self-management (Post-COAGS) Trial
|
N/A | |
Completed |
NCT04340388 -
Contribution of Dolutegravir to Obesity and Cardiovascular Disease
|
Phase 4 | |
Completed |
NCT03758092 -
Cardiovascular Screening in Infants Born Small for Gestational Age
|
||
Completed |
NCT03545672 -
Early Identification of Myocardial Impairment in PBC
|
||
Recruiting |
NCT06091384 -
Inspiratory Muscle Strength Training in Post-Covid Syndrome
|
N/A | |
Completed |
NCT04586894 -
Adverse Myocardial and Vascular Side Effects of Immune Checkpoint Inhibitors
|
||
Completed |
NCT03826914 -
The Effects of the Dietary Supplement CardioFlex Q10 on Reducing Cardiovascular Disease Risk Factors in Adults
|
N/A | |
Not yet recruiting |
NCT05624255 -
Correlating the Measure of Retinal Vascular Density Through Angio-OCT With Calcium Score
|
N/A | |
Completed |
NCT02966028 -
Effect of SNF472 on Progression of Cardiovascular Calcification in End-Stage-Renal-Disease (ESRD) Patients on Hemodialysis (HD)
|
Phase 2 | |
Completed |
NCT01820702 -
Short Term Bed Rest Study: Evaluation of the Use of Artificial Gravity, Induced by Short-arm Centrifugation
|
N/A | |
Recruiting |
NCT04766203 -
Relative Energy Deficiency in Sport Multicenter Study
|
N/A | |
Completed |
NCT01811667 -
Efficacy and Safety of the Mammalian Target of Rapamycin (mTor Rapamycin) Inhibitor in Vascular Malformations
|
Phase 3 | |
Terminated |
NCT02351726 -
Mitroflow DL Post Approval Study- North America
|
N/A | |
Completed |
NCT02616913 -
Evaluation of the Cardiac Effects of a Novel Food Ingredient in Healthy Male Subjects
|
N/A | |
Completed |
NCT00901394 -
Vitamin B12 and Folate Administration on Homocysteine Concentrations After Nitrous Oxide Anesthesia
|
N/A |