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

This study has been terminated.
(Low enrollment rates)
Sponsor:
Information provided by:
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00480077
First received: May 29, 2007
Last updated: February 5, 2010
Last verified: February 2010
  Purpose

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


Condition Intervention Phase
Heart Failure
Device: Programming (CRT-D, ICD OptiVol® and Cardiac Compass® )
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Diagnostic Outcome Trial in Heart Failure

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Enrollment: 336
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)
Arms Assigned Interventions
Experimental: Access Arm
HF subjects managed with standard clinical assessment and using OptiVol® Fluid status monitoring with Cardiac Compass Report
Device: Programming (CRT-D, ICD OptiVol® and Cardiac Compass® )
OptiVol® Fluid status Monitoring with Cardiac Compass
Other Name: OptiVol®
Active Comparator: Control arm
HF subjects managed with standard clinical assessment
Device: Programming (CRT-D, ICD OptiVol® and Cardiac Compass® )
OptiVol® Fluid status Monitoring with Cardiac Compass
Other Name: OptiVol®

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 Brussel
Principal Investigator: Prof. C.M. Yu Prince of Wales Hospital, Shatin, 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
Principal Investigator: Dr. M Lunati Azienda Ospedaliera Niguarda Ca' Granda
  More Information

No publications provided by Medtronic Bakken Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic, Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00480077     History of Changes
Other Study ID Numbers: 20061016-V2
Study First Received: May 29, 2007
Last Updated: February 5, 2010
Health Authority: Hungary: National Institute of Pharmacy

Keywords provided by Medtronic Bakken Research Center:
Heart Failure, randomized, OptiVol® Fluid status monitoring

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014