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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014