DECIDE-HF: Heart Rate Variability in Heart Failure Patients

NCT00949676 | Unknown

• 1 other identifier: DECIDE-HF
• Study Type: observational
• Target: 60
• Locations: 3 countries
• Sites: 5

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.

Conditions

Systolic Heart Failure

Outcome Measures

Primary Outcomes (1)

• HF diagnostic

  2 years

Study Arms (1)

Heart Failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Systolic Heart Failure Patients with NYHA class II or III and a ventricular ejection fraction of less then 40%.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic BRC: lead

Study Sites (5)

Unknown Facility

Antwerp, Belgium

Location

Unknown Facility

Kiel, Germany

Location

Unknown Facility

Munich, Germany

Location

Unknown Facility

Tübingen, Germany

Location

Unknown Facility

Leeds, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• DECIDE HF Team

  Medtronic BRC

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2009
• First Posted: July 30, 2009
• Study Start: September 1, 2009
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 23, 2013

Record last verified: 2013-09

Locations

GB (1); BE (1); DE (3)