- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00949676
DECIDE-HF: Heart Rate Variability in Heart Failure Patients (DECIDE-HF)
September 20, 2013 updated by: Medtronic BRC
DECIDE-HF - Heart Rate Variability in Heart Failure Patients
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Antwerpen, Belgium
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Kiel, Germany
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Munich, Germany
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Tubingen, Germany
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Leeds, United Kingdom
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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%.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Heart Failure
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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HF diagnostic
Time Frame: 2 years
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: DECIDE HF Team, Medtronic BRC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Anticipated)
November 1, 2013
Study Completion (Anticipated)
December 1, 2013
Study Registration Dates
First Submitted
July 28, 2009
First Submitted That Met QC Criteria
July 29, 2009
First Posted (Estimate)
July 30, 2009
Study Record Updates
Last Update Posted (Estimate)
September 23, 2013
Last Update Submitted That Met QC Criteria
September 20, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DECIDE-HF
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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