Heart Failure With Preserved Left Ventricular Ejection Fraction
Conditions
Brief summary
The purpose of this study is to evaluate the effects of functional electrical stimulation of peripheral muscles on clinical and emotional status, endothelial function and left ventricular diastolic function in heart failure with preserved left ventricular ejection fraction.
Interventions
OTHERFunctional electrical stimulation of peripheral muscles
Sponsors
Attikon Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(i) symptoms \[New York Heart Association (NYHA) class II or III\] and signs typical of heart failure (ii) left ventricular (LV) ejection fraction (LVEF) \>50% and LV end-diastolic volume index \<97 mL/m2 (iii) findings of left atrial (LA) dilatation (LA volume index \>40mL/m2), LV hypertrophy and/or LV diastolic dysfunction \[ie, mitral E/A ratio \<1 or \>2, mitral E/e' ratio \>15 or 8-15, (A pulmonary - A mitral) duration difference \>30 ms etc) (iv) no alterations in medical therapy during the previous 4 weeks (v) no myocardial infarction within 3 months prior to enrollment
Exclusion criteria
recent (≤4 weeks) heart failure decompensation * acute coronary syndrome * chronic inflammatory diseases and malignancies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exercise capacity | Six weeks |
| Quality of life | Six weeks |
| Emotional status | Six weeks |
Secondary
| Measure | Time frame |
|---|---|
| Left ventricular diastolic function | Six weeks |
| Endothelial function | Six weeks |
Other
| Measure | Time frame |
|---|---|
| Neurohormonal activation | Six weeks |
Countries
Greece
Outcome results
None listed