DECIDE-HF - Heart Rate Variability in Heart Failure Patients

Medtronic BRC0 sites60 target enrollmentSeptember 2009

ConditionsSystolic Heart Failure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Systolic Heart Failure
Sponsor: Medtronic BRC
Enrollment: 60
Primary Endpoint: HF diagnostic
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

December 2013

Last Updated

12 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Medtronic BRC

Responsible Party

Sponsor

Eligibility Criteria

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