DECIDE-HF: Heart Rate Variability in Heart Failure Patients (DECIDE-HF)
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ClinicalTrials.gov Identifier: NCT00949676
Verified September 2013 by Medtronic BRC. Recruitment status was: Active, not recruiting
The purpose of this study is to determine whether heart rate variability-like parameters are related to changes in the disease status of a subject that suffers from a disease that decreases the pumping function of the heart.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Systolic Heart Failure Patients with NYHA class II or III and a ventricular ejection fraction of less then 40%.
Subject has signed and dated the study-specific informed consent form
Subject is 18 years of age or older
Subject is expected to remain available for follow-ups
Subject is able and willing to comply with the protocol requirements
Subject has predominant Normal Sinus Rhythm
Subject has systolic Heart Failure and is at the moment of enrollment in NYHA class II or III and has an ejection fraction of less then 40%
Subject has had a HF-related hospitalization in the past 12 months
Subject needs permanent atrial pacing (> 10%)
Subject has intermittent 2nd or intermittent 3rd degree block
Subject has persistent or permanent AF
Subject has Long QT syndrome, Brugada syndrome, Jervell and Lange- Nielsen syndrome, Romano-Ward syndrome, Andersen-Tawil syndrome or Timothy's syndrome
Subject has had recent (<2 months) acute coronary syndrome
Subject has had recent (<2 months) revascularization
Subject has a pending cardiac transplant or revascularization
Subject has severe stenotic valvular heart disease
Subject has severe pulmonary (forced expiratory volume in 1 s < 1 L) hepatic or renal (plasma creatinine > 0.2 mmol/L) disease
Subject is participating in another study that may affect the results of this study