Status:
UNKNOWN
DECIDE-HF: Heart Rate Variability in Heart Failure Patients
Lead Sponsor:
Medtronic BRC
Conditions:
Systolic Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
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 pumpin...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00949676
Start Date
September 1 2009
End Date
December 1 2013
Last Update
September 23 2013
Active Locations (5)
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1
Antwerp, Belgium
2
Kiel, Germany
3
Munich, Germany
4
Tübingen, Germany