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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 20, 2014