DECIDE-HF: Heart Rate Variability in Heart Failure Patients

Systolic Heart Failure Clinical Trial

— DECIDE-HF  

Official title:

DECIDE-HF - Heart Rate Variability in Heart Failure Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00949676
• Other study ID #: DECIDE-HF
• Status: Active, not recruiting
• Phase: N/A
• First received: July 28, 2009
• Last updated: September 20, 2013
• Start date: September 2009
• Est. completion date: December 2013

Study information

• Verified date: September 2013
• Source: Medtronic BRC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the EnvironmentGermany: German Institute of Medical Documentation and InformationNetherlands: Ministry of Health, Welfare and SportUnited Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic
• Systolic Heart Failure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic BRC

Countries where clinical trial is conducted

Belgium,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HF diagnostic		2 years	No