Systolic Heart FailureDECIDE-HFNCT00949676
DECIDE-HF: Heart Rate Variability in Heart Failure Patients
An observational study of Systolic Heart Failure, run by Medtronic BRC at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systolic Heart Failure
- How many people
- 60 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Sep 2009to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Systolic Heart Failure Patients with NYHA class II or III and a ventricular ejection fraction of less then 40%.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
About this study
Official title: 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.
- Conditions
- Systolic Heart Failure
- Medical subject headings
- Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
HF diagnostic
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionNov 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systolic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic BRC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- DECIDE HF Team, Study chair, Medtronic BRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949676
- Sponsor's protocol ID
- DECIDE-HF
- Acronym
- DECIDE-HF
- Status last verified
- Sep 2013
- First submitted
- 28 Jul 2009
- Last updated
- 23 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DECIDE-HF - Heart Rate Variability in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT00949676
- Acronym / sponsor ID
- DECIDE-HF / DECIDE-HF
- Conditions
- Systolic Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medtronic BRCIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 30 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Systolic Heart Failure Patients with NYHA class II or III and a ventricular ejection fraction of less then 40%.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HF diagnostic
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2013.
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Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
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A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
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Advancing Clinical Heart Failure Outcomes Leveraging Defibrillation Lead Implant System for Left Bundle Branch Area Pacing
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The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial (STICH3C)
Coronary Artery Disease, Heart Failure Systolic
RecruitingPhase 3
A Study to Learn More About How Well Finerenone Works, How Safe it is, and How it Moves Into, Through, and Out of the Body Compared to Placebo When Taken With Standard Treatment in Children With Heart Failure and Left Ventricular Systolic Dysfunction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DECIDE HF Team study chair
Medtronic BRC
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systolic Heart Failure, run by Medtronic BRC at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Belgium, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HF diagnostic (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2013; AzTrials last refreshed its copy on 3 Nov 2026.