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

Primary Purpose

Heart Failure

Status

Terminated

Phase

Phase 4

Locations

Netherlands

Study Type

Interventional

Intervention

Programming (CRT-D, ICD OptiVol® and Cardiac Compass® )

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, randomized, OptiVol® Fluid status monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medtronic Bakken Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Access Arm

Control arm

Arm Description

HF subjects managed with standard clinical assessment and using the audible OptiVol® Fluid status monitoring alert and the device Cardiac Compass Report

HF subjects managed with standard clinical assessment

Outcomes

Primary Outcome Measures

Number of Participants With Combined End Point of All-cause Mortality or Heart Failure Hospitalization

Number of participants with a combined end point of all-cause mortality or heart failure hospitalization

Secondary Outcome Measures

Full Information

NCT ID

NCT00480077

First Posted

May 29, 2007

Last Updated

February 15, 2019

Sponsor

Medtronic Bakken Research Center

1. Study Identification

Unique Protocol Identification Number

NCT00480077

Brief Title

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

Acronym

DOT-HF

Official Title

Diagnostic Outcome Trial in Heart Failure

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Terminated

Why Stopped

Low enrollment rates

Study Start Date

March 2007 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Bakken Research Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

Heart Failure, randomized, OptiVol® Fluid status monitoring

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Intervention: in the access arm the patiens had programmmed the audible OptiVol Fliud status alert "on". Control patienst had programmed the audible alert "off"

Masking

None (Open Label)

Allocation

Randomized

Enrollment

335 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Access Arm

Arm Type

Experimental

Arm Description

HF subjects managed with standard clinical assessment and using the audible OptiVol® Fluid status monitoring alert and the device Cardiac Compass Report

Arm Title

Control arm

Arm Type

Active Comparator

Arm Description

HF subjects managed with standard clinical assessment

Intervention Type

Device

Intervention Name(s)

Programming (CRT-D, ICD OptiVol® and Cardiac Compass® )

Other Intervention Name(s)

OptiVol® audible alert

Intervention Description

OptiVol® Fluid status Monitoring with Cardiac Compass

Primary Outcome Measure Information:

Title

Number of Participants With Combined End Point of All-cause Mortality or Heart Failure Hospitalization

Description

Number of participants with a combined end point of all-cause mortality or heart failure hospitalization

Time Frame

14.9 ± 5.4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: