DECIDE-HF: Heart Rate Variability in Heart Failure Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic BRC
ClinicalTrials.gov Identifier:
NCT00949676
First received: July 28, 2009
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

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
Systolic Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: DECIDE-HF - Heart Rate Variability in Heart Failure Patients

Resource links provided by NLM:


Further study details as provided by Medtronic BRC:

Primary Outcome Measures:
  • HF diagnostic [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Heart Failure

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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%.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949676

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

No publications provided

Responsible Party: Medtronic BRC
ClinicalTrials.gov Identifier: NCT00949676     History of Changes
Other Study ID Numbers: DECIDE-HF
Study First Received: July 28, 2009
Last Updated: September 20, 2013
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
Germany: German Institute of Medical Documentation and Information
Netherlands: Ministry of Health, Welfare and Sport
United Kingdom: National Health Service

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

ClinicalTrials.gov processed this record on April 16, 2014