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

Medtronic

Status and phase: Terminated; Phase 4

Conditions: Heart Failure

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00480077

20061016-V2

Details and patient eligibility

About

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

Full 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)

Enrollment: 335 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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335 participants in 2 patient groups

Access Arm

Experimental group

Description:

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

Treatment:

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

Control arm

Active Comparator group

Description:

HF subjects managed with standard clinical assessment

Treatment:

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