Systolic Heart Failure
Conditions
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.
Interventions
None listed
Sponsors
Medtronic BRC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HF diagnostic | 2 years |
Countries
Belgium, Germany, United Kingdom
Outcome results
None listed