Heart FailurePhase 4DOT-HFNCT00480077

Diagnostic Outcome Trial in Heart Failure (DOT-HF Trial)

A Phase 4 study testing Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ) in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The DOT-HF trial is an international, prospective, multi-center, randomized, controlled trial. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Failure
What is being tested?: Programming (CRT-D, ICD OptiVol® and Cardiac Compass® )
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 335 participants
Where: 1 siteNetherlands
Study dates: Mar 2007to Jan 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Subjects of both genders with mild to severe HF as defined as NHYA Class II to IV who also have an indication for device implant according to ESC/AHA guidelines as well as having a HF hospitalization or Emergency Department visit necessitating therapy within the past 12 months and who meet all inclusion criteria and no exclusion criteria, are eligible for this study.

Who cannot join

Subject is post heart transplant or actively listed on the transplant list and reasonable probability (as defined by investigator) of undergoing transplantation in the next year
Subject received a coronary artery bypass graft or valve surgery in last 90 days
Subject with a myocardial infarction (MI) in the last 40 days.
Subject's life expectancy is less than one year in the opinion of the physician
Subject has severe Chronic Obstructive Pulmonary Disease (COPD), as determined by physician and documented in medical records
Subject is listed for valve replacement/valve repair

Show all 11Show fewer

Subject has severe, primary pulmonary hypertension as determined by physician and documented in medical records
Subject with serum creatinine ≥ 2.5 mg/dL measured within 14 days prior to enrolment
Subject on chronic renal dialysis
Subject on continuous or uninterrupted (≥ 2 stable infusions per week) infusion (inotropic) therapy for HF
Subject has complex and uncorrected Congenital Heart Disease

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Medtronic Bakken Research Center
Maastricht, 6229 GW

Other trials in Netherlands

About this study

Official title: Diagnostic Outcome Trial in Heart Failure

The DOT-HF trial is an international, prospective, multi-center, randomized, controlled trial.

Read the detailed description

The study was designed with a Control Arm in order to adequately study the effect of early intervention triggered by the OptiVol® Alert and/or SentryCheck™ Monitor/PatientLook™ Indicator and evaluation using OptiVol® Fluid Status Monitoring with Cardiac Compass. OptiVol® Fluid Status Monitoring with Cardiac Compass features are available in the per Clinical Investigational Plan specified Medtronic products (CRT, CRT-D and ICD devices)

Conditions: Heart Failure
Being tested: Programming (CRT-D, ICD OptiVol® and Cardiac Compass® )
Keywords: Heart Failure, randomized, OptiVol® Fluid status monitoring
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Programming (CRT-D, ICD OptiVol® and Cardiac Compass® )Device
Also called OptiVol® audible alert
OptiVol® Fluid status Monitoring with Cardiac Compass

Study groups in NCT00480077
Study group	Role	What they receive
Access Arm	Experimental	HF subjects managed with standard clinical assessment and using the audible OptiVol® Fluid status monitoring alert and the device Cardiac Compass Report Receives: Device: Programming (CRT-D, ICD OptiVol® and Cardiac Compass® )
Control arm	Active comparator	HF subjects managed with standard clinical assessment Receives: Device: Programming (CRT-D, ICD OptiVol® and Cardiac Compass® )

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Combined End Point of All-cause Mortality or Heart Failure Hospitalization
Number of participants with a combined end point of all-cause mortality or heart failure hospitalization
Measured: 14.9 ± 5.4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2007Jan 2011

First posted30 May 2007 (estimated)
Study startMar 2007
Primary completionJan 2011
Study completionJan 2011

Why it stopped: Low enrollment rates

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Heart FailureStudies of the same condition, open and under way.
More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Intervention: in the access arm the patiens had programmmed the audible OptiVol Fliud status alert "on". Control patienst had programmed the audible alert "off"
Masking: None (open label)
Enrolment: 335 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00480077
Sponsor's protocol ID: 20061016-V2
Acronym: DOT-HF
Status last verified: Feb 2019
First submitted: 29 May 2007
Last updated: 2 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

van Veldhuisen DJ, Braunschweig F, Conraads V, Ford I, Cowie MR, Jondeau G, Kautzner J, Aguilera RM, Lunati M, Yu CM, Gerritse B, Borggrefe M; DOT-HF Investigators. Intrathoracic impedance monitoring, audible patient alerts, and outcome in patients with heart failure. Circulation. 2011 Oct 18;124(16):1719-26. doi: 10.1161/CIRCULATIONAHA.111.043042. Epub 2011 Sep 19.
PubMed 21931078
Conraads VM, Spruit MA, Braunschweig F, Cowie MR, Tavazzi L, Borggrefe M, Hill MR, Jacobs S, Gerritse B, van Veldhuisen DJ. Physical activity measured with implanted devices predicts patient outcome in chronic heart failure. Circ Heart Fail. 2014 Mar 1;7(2):279-87. doi: 10.1161/CIRCHEARTFAILURE.113.000883. Epub 2014 Feb 11.
PubMed 24519908

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Diagnostic Outcome Trial in Heart Failure
ClinicalTrials.gov ID: NCT00480077
Acronym / sponsor ID: DOT-HF / 20061016-V2
Conditions: Heart Failure
Keywords: Heart Failure, randomized, OptiVol® Fluid status monitoring
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Low enrollment rates
Enrolment: 335 participants (actual)
Lead sponsor: Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
Study start: Mar 2007
Primary completion: Jan 2011 (actual)
Study completion: Jan 2011 (actual)
First posted: 30 May 2007 (estimated)
Results: Posted 19 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The DOT-HF trial is an international, prospective, multi-center, randomized, controlled trial.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Intervention: in the access arm the patiens had programmmed the audible OptiVol Fliud status alert "on". Control patienst had programmed the audible alert "off"

Arm	Type	Receives
Access Arm	Experimental	Device: Programming (CRT-D, ICD OptiVol® and Cardiac Compass® )HF subjects managed with standard clinical assessment and using the audible OptiVol® Fluid status monitoring alert and the device Cardiac Compass Report
Control arm	Active comparator	Device: Programming (CRT-D, ICD OptiVol® and Cardiac Compass® )HF subjects managed with standard clinical assessment

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Subjects of both genders with mild to severe HF as defined as NHYA Class II to IV who also have an indication for device implant according to ESC/AHA guidelines as well as having a HF hospitalization or Emergency Department visit necessitating therapy within the past 12 months and who meet all inclusion criteria and no exclusion criteria, are eligible for this study.

Key exclusion criteria (11 listed)

Subject is post heart transplant or actively listed on the transplant list and reasonable probability (as defined by investigator) of undergoing transplantation in the next year
Subject received a coronary artery bypass graft or valve surgery in last 90 days
Subject with a myocardial infarction (MI) in the last 40 days.
Subject's life expectancy is less than one year in the opinion of the physician
Subject has severe Chronic Obstructive Pulmonary Disease (COPD), as determined by physician and documented in medical records

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Programming (CRT-D, ICD OptiVol® and Cardiac Compass® )Also: OptiVol® audible alertOptiVol® Fluid status Monitoring with Cardiac Compass	Device	Access Arm, Control arm

Primary outcome

Number of Participants With Combined End Point of All-cause Mortality or Heart Failure Hospitalization
Time frame: 14.9 ± 5.4 months
Number of participants with a combined end point of all-cause mortality or heart failure hospitalization

Results and safety

Results posted to the registry on 19 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Access Arm	168	137
Control Arm	167	141

Primary outcome: Number of Participants With Combined End Point of All-cause Mortality or Heart Failure Hospitalization

Time frame: 14.9 ± 5.4 months. Count of participants. Unit: Participants

Measure	Access Arm n = 168	Control Arm n = 167
Value	48	33

Access Arm vs Control Arm: p = 0.063, Log Rank

Adverse events

Time frame: mean follow up period (months): 14.9 +/- 5.4. Other adverse events reported at 2.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Access Arm	50 of 168 (29.8%)	47 of 168 (28%)	Not reported
Control Arm	34 of 167 (20.4%)	20 of 167 (12%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21931078van Veldhuisen DJ, Braunschweig F, Conraads V, Ford I, Cowie MR, Jondeau G, Kautzner J, Aguilera RM, Lunati M, Yu CM, Gerritse B, Borggrefe M; DOT-HF Investigators. Intrathoracic impedance monitoring, audible patient alerts, and outcome in patients with heart failure. Circulation. 2011 Oct 18;124(16):1719-26. doi: 10.1161/CIRCULATIONAHA.111.043042. Epub 2011 Sep 19.
Derived from this study: PubMed 24519908Conraads VM, Spruit MA, Braunschweig F, Cowie MR, Tavazzi L, Borggrefe M, Hill MR, Jacobs S, Gerritse B, van Veldhuisen DJ. Physical activity measured with implanted devices predicts patient outcome in chronic heart failure. Circ Heart Fail. 2014 Mar 1;7(2):279-87. doi: 10.1161/CIRCHEARTFAILURE.113.000883. Epub 2014 Feb 11.

Related trials for Heart Failure

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

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.

Prof. D.J. van Veldhuisen, MD study chair

Groningen University Hospital, The Netherlands

Prof. Dr. med. M. Borggrefe study chair

Ruprecht-Karls-Universität Heidelberg, Germany

Prof. Dr. V. Conraads principal investigator

Universitair Ziekenhuis Brussel

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ) in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Netherlands.

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 1 inclusion and 11 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: stopped early, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Combined End Point of All-cause Mortality or Heart Failure Hospitalization (time frame: 14.9 ± 5.4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00480077, which also lists 2 linked publications.

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 2 Jul 2025.