Diagnostic Outcome Trial in Heart Failure (DOT-HF Trial)
NCT ID: NCT00480077
Last Updated: 2025-07-02
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
335 participants
INTERVENTIONAL
2007-03-31
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Access Arm
HF subjects managed with standard clinical assessment and using the audible OptiVol® Fluid status monitoring alert and the device Cardiac Compass Report
Programming (CRT-D, ICD OptiVol® and Cardiac Compass® )
OptiVol® Fluid status Monitoring with Cardiac Compass
Control arm
HF subjects managed with standard clinical assessment
Programming (CRT-D, ICD OptiVol® and Cardiac Compass® )
OptiVol® Fluid status Monitoring with Cardiac Compass
Interventions
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Programming (CRT-D, ICD OptiVol® and Cardiac Compass® )
OptiVol® Fluid status Monitoring with Cardiac Compass
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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Prof. D.J. van Veldhuisen, MD
Role: STUDY_CHAIR
Groningen University Hospital, The Netherlands
Prof. Dr. med. M. Borggrefe
Role: STUDY_CHAIR
Ruprecht-Karls-Universität Heidelberg, Germany
Prof. Dr. V. Conraads
Role: PRINCIPAL_INVESTIGATOR
Universitair Ziekenhuis Brussel
Prof. C.M. Yu
Role: PRINCIPAL_INVESTIGATOR
Prince of Wales Hospital, Shatin, Hong Kong
Dr. F. Braunschweig
Role: PRINCIPAL_INVESTIGATOR
Karolinska University Hospital
Prof. Dr. J. Kautzner
Role: PRINCIPAL_INVESTIGATOR
IKEM- Klinika Kardiologie, Czech Republic
Prof. Dr. G. Jondeau
Role: PRINCIPAL_INVESTIGATOR
Hôpital Bichat Claude Bernard, France
Prof. Dr. M.R. Cowie
Role: PRINCIPAL_INVESTIGATOR
National Heart & Lung Institute, United Kingdom
Dr. R. Muñoz-Aguilera
Role: PRINCIPAL_INVESTIGATOR
Hospital General Universitario Gregorio Marañon, Spain
Prof. I. Ford
Role: PRINCIPAL_INVESTIGATOR
Robertson Center for Biostatistics, Scotland
Dr. M Lunati
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera Niguarda Ca' Granda
Locations
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Medtronic Bakken Research Center
Maastricht, , Netherlands
Countries
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References
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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.
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.
Other Identifiers
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20061016-V2
Identifier Type: -
Identifier Source: org_study_id
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