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

June 30, 2025 updated by: Medtronic Cardiac Rhythm and Heart Failure

Diagnostic Outcome Trial in Heart Failure

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

335

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6229 GW
        • Medtronic Bakken Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Access Arm
HF subjects managed with standard clinical assessment and using the audible OptiVol® Fluid status monitoring alert and the device Cardiac Compass Report
Device: Programming (CRT-D, ICD OptiVol® and Cardiac Compass® )
OptiVol® Fluid status Monitoring with Cardiac Compass
Other Names:
  • OptiVol® audible alert
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 Names:
  • OptiVol® audible alert

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14.9 ± 5.4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

May 29, 2007

First Submitted That Met QC Criteria

May 29, 2007

First Posted (Estimated)

May 30, 2007

Study Record Updates

Last Update Posted (Actual)

July 2, 2025

Last Update Submitted That Met QC Criteria

June 30, 2025

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20061016-V2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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