Functional Electrical Stimulation of Peripheral Muscles in Heart Failure With Preserved Left Ventricular Ejection Fraction

Attikon University Hospital

Status and phase: Completed; Phase 2

Conditions: Heart Failure With Preserved Left Ventricular Ejection Fraction

Treatments: Other: Functional electrical stimulation of peripheral muscles

Study type: Interventional

Funder types: Other

Identifiers

NCT01829607

FES-HFPEF

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Functional electrical stimulation

Active Comparator group

Description:

Functional electrical stimulation of lower limbs

Treatment:

Other: Functional electrical stimulation of peripheral muscles

Placebo

Placebo Comparator group