heart failure with preserved ejection fraction
Conditions
Interventions
transcutaneous vagus nerve stimulation
Sponsors
KAGAMI KAZUKI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients meeting all of the following criteria will be included: 1) Patients aged 18 years or older. 2) Patients with HFpEF. 3) Patients who have provided written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will be excluded: 1) Moderate or greater mitral stenosis, moderate or greater aortic stenosis, severe mitral regurgitation, severe aortic regurgitation, triple-vessel coronary artery disease, left main trunk disease, decompensated heart failure, or cardiomyopathy. 2) Presence of an implanted pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) device. 3) History of recurrent vasovagal syncope. 4) Second-degree or higher atrioventricular block. 5) Sick sinus syndrome. 6) Bradycardia with a resting heart rate of less than 50 bpm. 7) Acute coronary syndrome within 48 hours of onset. 8) Uncontrolled heart failure or respiratory failure. 9) Uncontrolled hypertension. 10) Lethal arrhythmia. 11) Acute phase of aortic dissection or impending rupture of an aortic aneurysm. 12) Inability to perform exercise. 13) Participation in other interventional trials. 14) Patients who are deemed unable to understand the explanation regarding participation in the study and to give written consent based on their own free will. 15) Other patients deemed inappropriate for the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in peripheral venous pressure (mmHg) during maximal exercise from baseline to post-intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in peripheral venous pressure during 20W exercise from baseline to post-intervention (mmHg) 2) Change in maximal exercise heart rate from baseline to post-intervention 3) Change in maximal exercise blood pressure from baseline to post-intervention 4) Change in maximal exercise intensity and exercise duration from baseline to post-intervention 5) Change in Borg Scale from baseline to post-intervention 6) Change in cardiopulmonary exercise testing (CPET) parameters (Peak VO2, RER, VE, VT, VE vs. VCO2 slope) from baseline to post-intervention 7) Change in exercise echocardiographic parameters (E/e ratio, PASP, cardiac output, stroke volume, TAPSE, TVs', left ventricular strain, left atrial strain, right ventricular strain, and right atrial strain) from baseline to post-intervention 8) Change in blood biomarkers (NT-proBNP, CRP, TNF-a, IL-8 from baseline to post-intervention 9) Change in heart rate variability (HRV) parameters (RR interval, max, min, mean HR, SDNN, RMSSD) from baseline to post-intervention 10) Change in body composition indicators (skeletal muscle mass of the limbs, muscle mass, fat mass, body water content) from baseline to post-intervention 11) Transcriptome analysis of whole blood after lipopolysaccharide (LPS) stimulation | — |
Contacts
Public ContactKAZUKI KAGAMI
Gunma University Graduate School of Medicine
Outcome results
None listed