Frail elderly patients with acute decompensated heart failure
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients who were hospitalized for acute exacerbation of heart failure 2) Aged 75 years or older 3) Frail patients (Short Physical Performance Battery score 4-9)
Exclusion criteria
Exclusion criteria: 1) BNP < 100 pg/ml at admission 2) Cognitive dysfunction 3) Acute coronary syndrome 4) Significant myocardial ischemia during low-intensity exercise 5) Resting heart rate > 120/min 6) Acute infective endocarditis, myocarditis, and pericaritis 7) Presence of a recent hospitalization for heart failure (< 1 month) 8) Severe symptomatic aortic stenosis, mitral stenosis, and hypertrophic obstructive cardiomyopathy 9) Severe pulmonary hypertension 10) Intracardiac thrombus 11) Untreated life-threatening arrhythmia 12) Resting blood pressure > 180 mmHg 13) Ongoing orthopnea 14) Requiring high inotropic support 15) Patients with circulatory assist device 16) Patients with inadequate oxygenation 17) Patients with mechanical ventilation 18) History of aortic dissection, or presence of aortic aneurysm or aortic dissection 19) Patients with uncontrolled diabetes 20) Peripheral arterial disease (Fontain 3-4) 21) Recent embolism 22) Patients undergoing hemodialysis 23) Serum creatinine > 3.0 mg/dl 24) Severe anemia 25) Short life expectancy due to advanced disease other than heart failure 26) Patients who needed assistance for walking a month before hospitalization 27) Pregnant, lactational woman, patients may be pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quadriceps Strength [Time Frame: Measured at baseline and 2 weeks] | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical function, Six-minute walk distance, Cognitive function, Cardiac and renal function [Time Frame: Measured at baseline and 2 weeks] Subgroup analysis (Statistical significance level of p-value for interaction: <0.1): Gender, LVEF >=50%, Quadriceps strength >median value, six-minute walk distance >median value, Age >=85 years | — |
Countries
Japan
Contacts
Kitasato University Graduate School of Medical Sciences