Heart failure
Conditions
Interventions
Combination therapy of conventional outpatient CR and cardiac telerehabilitation
Sponsors
National Cerebral and Cardiovascular Center
Remohab Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who are indicated for outpatient CR 2. Patients with heart failure 3. Patients with written consent 4. Over 60 years old
Exclusion criteria
Exclusion criteria: 1. NYHA class 4 2. Patients with LVEF of 40% or less who developed myocardial infarction within 90 days 3. History of syncope or cardiopulmonary arrest(CPA) with unknown cause or no treatment 4. History of syncope, CPA or ICD/CRT-D appropriate or inappropriate therapy within the past one year(Patients with implantable devices are excluded after April 24, 2020) 5. Unstable angina or lower threshold angina 6. Severe stenotic valvular disease 7. The Following adverse events occur when the exercise intensity is less than the anaerobic threshold at the time of symptom-limited exercise test or CR before cardiac telerehabilitation introduction 7.1 Nonsustained/sustained ventricular tachycardia or ventricular fibrillation 7.2 R on T type ventricular premature contraction (VPC) 7.3 Frequent VPC (more than 30%) 7.4 Couplet VPC (two or more times a minute) 7.5 Second- or third-degree atrioventricular block 7.6 progressive blood pressure drop during exercise 7.7 Vagal reflexes after exercise below the exercise prescription intensity (Vagal reflexes after symptom-limited exercise test are not included in the exclusion criteria) 8. Schedule within three months for cardiovascular surgery, and implantation of pacemakers (including CRT) and ICDs 9. Patients with ventricular assist devices 10. End-stage patients 11. Patients who have difficulty operating the cardiac telerehabilitation system 12. Patients who can not establish a telecommunication system at home 13. Patients who have difficulty in securing time for participation in CR due to working or schooling 14. Patients who have already participated in or plan to participate in other clinical trials (except for registry studies) 15. Patients for whom the study investigator or the attending physician judged inappropriate to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients who improved peak VO2 by more than 6% after three months of CR | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of change of the following indicators during three months of CR 1. Peak VO2 2. Peak work rate 3. 6-minute walking distance 4. Brain natriuretic peptide 5. Body weight 6. Body composition 7. Nutritional index 8. Depression index 9. Serum lipid level 10. Blood sugar level, HbA1c 11. Renal function 12. Blood pressure 13. Heart failure self-care ability The following indicators during three months of CR 14. Physical activity 15. Rate of smoking cessation 16. Participation rate in CR | — |
Countries
Japan
Contacts
Public ContactHiroyuki Miura
National Cerebral and Cardiovascular Center Cardiovascular medicine
Outcome results
None listed