DECIDE-HF: Heart Rate Variability in Heart Failure Patients (DECIDE-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00949676
Recruitment Status : Unknown
Verified September 2013 by Medtronic BRC.
Recruitment status was:  Active, not recruiting
First Posted : July 30, 2009
Last Update Posted : September 23, 2013
Information provided by (Responsible Party):
Medtronic BRC

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.

Condition or disease
Systolic Heart Failure

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DECIDE-HF - Heart Rate Variability in Heart Failure Patients
Study Start Date : September 2009
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Heart Failure

Primary Outcome Measures :
  1. HF diagnostic [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00949676

Antwerpen, Belgium
Kiel, Germany
Munich, Germany
Tubingen, Germany
United Kingdom
Leeds, United Kingdom
Sponsors and Collaborators
Medtronic BRC
Study Chair: DECIDE HF Team Medtronic BRC

Responsible Party: Medtronic BRC Identifier: NCT00949676     History of Changes
Other Study ID Numbers: DECIDE-HF
First Posted: July 30, 2009    Key Record Dates
Last Update Posted: September 23, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases