DECIDE-HF: Heart Rate Variability in Heart Failure Patients
This study is currently recruiting participants.
Verified August 2011 by Medtronic BRC
Sponsor:
Medtronic BRC
Information provided by:
Medtronic BRC
ClinicalTrials.gov Identifier:
NCT00949676
First received: July 28, 2009
Last updated: August 1, 2011
Last verified: August 2011
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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:
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | March 2012 (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
Contacts
| Contact: DECIDE HF Team | medtroniccrmtrials@medtronic.com |
Locations
| Belgium | |
| Recruiting | |
| Antwerpen, Belgium | |
| Germany | |
| Recruiting | |
| Kiel, Germany | |
| Recruiting | |
| Munich, Germany | |
| Recruiting | |
| Tubingen, Germany | |
| Netherlands | |
| Not yet recruiting | |
| Groningen, Netherlands | |
| United Kingdom | |
| Recruiting | |
| Leeds, United Kingdom | |
Sponsors and Collaborators
Medtronic BRC
Investigators
| Study Chair: | DECIDE HF Team | Medtronic BRC |
More Information
No publications provided
| Responsible Party: | Sandra Jacobs, Medtronic BRC |
| ClinicalTrials.gov Identifier: | NCT00949676 History of Changes |
| Other Study ID Numbers: | DECIDE-HF |
| Study First Received: | July 28, 2009 |
| Last Updated: | August 1, 2011 |
| 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 May 16, 2013