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

Phase 2

Completed

• Conditions: Heart Failure With Preserved Left Ventricular Ejection Fraction
• Interventions: Other: Functional electrical stimulation of peripheral muscles

• Registration Number: NCT01829607
• Lead Sponsor: Attikon Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2012-10
• Status Verified: 2013-04
• Study First Submitted: 2013-04-09
• Study First Submitted QC: 2013-04-10
• Last Update Submitted: 2013-04-10
• Study First Posted: 2013-04-11
• Last Update Posted: 2013-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Functional electrical stimulation	Functional electrical stimulation of peripheral muscles	Functional electrical stimulation of lower limbs

Primary Outcome Measures

Name	Time	Method
Exercise capacity	Six weeks
Quality of life	Six weeks
Emotional status	Six weeks

Secondary Outcome Measures

Name	Time	Method
Left ventricular diastolic function	Six weeks
Endothelial function	Six weeks

Trial Locations

Locations (1)

Attikon University Hospital; 🇬🇷 Athens, Greece