Heart Failure With Preserved Left Ventricular Ejection Fraction Clinical Trial
| NCT number | NCT01829607 |
| Other study ID # | FES-HFPEF |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | April 9, 2013 |
| Last updated | April 10, 2013 |
| Start date | January 2011 |
| Verified date | April 2013 |
| Source | Attikon Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Greece: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | |
| Est. primary completion date | October 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Greece | Attikon University Hospital | Athens |
| Lead Sponsor | Collaborator |
|---|---|
| Attikon Hospital |
Greece,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Neurohormonal activation | Six weeks | No | |
| Primary | Exercise capacity | Six weeks | No | |
| Primary | Quality of life | Six weeks | No | |
| Primary | Emotional status | Six weeks | No | |
| Secondary | Left ventricular diastolic function | Six weeks | No | |
| Secondary | Endothelial function | Six weeks | No |