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

This study is ongoing, but not recruiting participants.

First Received: May 29, 2007 Last Updated: February 6, 2009 History of Changes

Sponsored by:	Medtronic Bakken Research Center
Information provided by:	Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:	NCT00480077

Purpose

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

Condition	Intervention	Phase
Heart Failure	Device: Programming (CRT-D, CRT, ICD OptiVol® and Cardiac Compass® )	Phase III

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Diagnostic Outcome Trial in Heart Failure

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:

Primary objective is to investigate if a reduction in combined endpoint of HF hospitalizations and all-cause mortality, in HF subjects managed with standard clinical assessment and using OptiVol® Fluid Status Monitoring with Cardiac Compass Report [ Time Frame: study duration ]

Estimated Enrollment:	2300
Study Start Date:	March 2007
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480077

Locations

Netherlands
Medtronic Bakken Research Center
Maastricht, Netherlands, 6229 GW

Sponsors and Collaborators

Medtronic Bakken Research Center

Investigators

Study Chair:	Prof. D.J. van Veldhuisen, MD	Groningen University Hospital, The Netherlands
Study Chair:	Prof. Dr. med. M. Borggrefe	Ruprecht-Karls-Universität Heidelberg, Germany
Principal Investigator:	Prof. Dr. V. Conraads	Universitair Ziekenhuis Antwerpen, Belgium
Principal Investigator:	Prof. C.M. Yu	Prince of Wales Hospital, Hong Kong
Principal Investigator:	Dr. F. Braunschweig	Karolinska University Hospital
Principal Investigator:	Prof. Dr. J. Kautzner	IKEM- Klinika Kardiologie, Czech Republic
Principal Investigator:	Prof. Dr. G. Jondeau	Hôpital Bichat Claude Bernard, France
Principal Investigator:	Prof. Dr. M.R. Cowie	National Heart & Lung Institute, United Kingdom
Principal Investigator:	Dr. R. Muñoz-Aguilera	Hospital General Universitario Gregorio Marañon, Spain
Principal Investigator:	Prof. I. Ford	Robertson Center for Biostatistics, Scotland

More Information

No publications provided

Study ID Numbers:	20061016-V2
Study First Received:	May 29, 2007
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00480077 History of Changes
Health Authority:	Hungary: National Institute of Pharmacy

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009