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

Phase 4

Terminated

• Conditions: Heart Failure

• Registration Number: NCT00480077
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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)

Study Timeline

• Study Start: 2007-03-01
• Study First Submitted: 2007-05-29
• Study First Submitted QC: 2007-05-29
• Study First Posted: 2007-05-30
• Primary Completion: 2011-01
• Study Completion: 2011-01-01
• Results First Submitted: 2017-11-16
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-15
• Results First Posted: 2019-02-19
• Last Update Submitted: 2025-06-30
• Last Update Posted: 2025-07-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 335

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants With Combined End Point of All-cause Mortality or Heart Failure Hospitalization	14.9 ± 5.4 months	Number of participants with a combined end point of all-cause mortality or heart failure hospitalization

Trial Locations

Locations (1)

Medtronic Bakken Research Center; 🇳🇱 Maastricht, Netherlands