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Status unknownNCT00949676DECIDE-HFUpdated Sep 23, 2013

DECIDE-HF: Heart Rate Variability in Heart Failure Patients

An observational study in Systolic Heart Failure, sponsored by Medtronic BRC. Status unknown at 5 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-23.

Sponsored by Medtronic BRC · Observational

The sponsor has not verified this record recently (last verified Sep 2013), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Systolic Heart Failure
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 60 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Medtronic BRC is the lead sponsor of 25 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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%.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)

Groups and cohorts

  • Heart Failure
06

What researchers measure

Primary outcomes

  1. HF diagnostic

    Time frame: 2 years

07

Study locations

5 sites
  • Antwerpen, Belgium
  • Kiel, Germany
  • Munich, Germany
  • Tubingen, Germany
  • Leeds, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00949676
Lead sponsor
Medtronic BRC
Responsible party
Sponsor
First posted
Jul 30, 2009
Start date
Sep 2009
Primary completion
Nov 2013 (estimated)
Completion
Dec 2013 (estimated)
Last update
Sep 23, 2013

Study contacts

DECIDE HF Team
study chair · Medtronic BRC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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