DECIDE-HF: Heart Rate Variability in Heart Failure Patients
This trial is active, not recruiting.
|Condition||systolic heart failure|
|Start date||September 2009|
|End date||November 2013|
|Trial size||60 participants|
|Trial identifier||NCT00949676, DECIDE-HF|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Antwerpen, Belgium||not available||no longer recruiting|
|Kiel, Germany||not available||no longer recruiting|
|Munich, Germany||not available||no longer recruiting|
|Tubingen, Germany||not available||no longer recruiting|
|Leeds, United Kingdom||not available||no longer recruiting|
time frame: 2 years
Male or female participants at least 18 years old.
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
|Official title||DECIDE-HF - Heart Rate Variability in Heart Failure Patients|
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