DECIDE-HF: Heart Rate Variability in Heart Failure Patients
- Conditions
- Systolic Heart Failure
- Registration Number
- NCT00949676
- Lead Sponsor
- Medtronic BRC
- 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 pumping function of the heart.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HF diagnostic 2 years
- Secondary Outcome Measures
Name Time Method