Home Telemonitoring Study for Patients with Chronic Heart Failure
Not Applicable
- Conditions
- chronic heart failure
- Registration Number
- JPRN-UMIN000006839
- Lead Sponsor
- Department of Cardiovascular Medicine, Saga university
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 420
Inclusion Criteria
Not provided
Exclusion Criteria
currently implanted or scheduled for pacemaker, implantable cardioverter defibrillator, or bi-ventricular pacemaker (with defibrillator), because the scale for present study emits a faint alternating current to measure body impedance; advanced renal insufficiency (i.e. serum creatinine 3.0 mg/ld or more); severe liver dysfunction; planned percutaneous coronary intervention or coronary artery bypass grafting; limited life expectancy because of malignant disease; severe cognitive impairment or mental illness; pregnancy; deemed unable to stand on a scale safely; no access to a telephone line
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method time to all-cause death or readmission for heart failure decompensation
- Secondary Outcome Measures
Name Time Method 1. time to all-cause death 2. time to cardiovascular death 3. time to all-cause readmissions 4. time to cardiovascular readmissions 5. time to readmissions for heart failure decompensation 6. changes in New York Heart Association functional class (NYHA) 7. cost effectiveness 8. changes in left ventricular ejection fraction (EF) 9. changes in N-terminal pro-BNP (NT-proBNP), high-sensitivity C-reactive protein (hsCRP), pentraxin3 (PTX3), adipose triglyceride lipase (ATGL), high-sensitivity troponin T (hsTnT), receptor for advanced glycation end products (RAGE), and high-molecular weight adiponectin 10. cognitive function (Mini Mental State Examination; MMSE) 11. patient's self efficacy (General Self Efficacy Scale; GSES) 12. heart failure related quality of life (QOL) as measured by the Minnesota Living with Heart Failure (MLWHF) 13. adherance for medication 14. anxiety and deession as measured by Patient Health Questionnaire 9 (PHQ-9)