This trial is active, not recruiting.

Condition systolic heart failure
Sponsor Medtronic BRC
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

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

HF diagnostic
time frame: 2 years

Eligibility Criteria

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

Additional Information

Official title DECIDE-HF - Heart Rate Variability in Heart Failure Patients
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by Medtronic BRC.