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

Heart Failure Clinical Trial

— DOT-HF  

Official title:

Diagnostic Outcome Trial in Heart Failure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00480077
• Other study ID #: 20061016-V2
• Status: Terminated
• Phase: Phase 4
• Start date: March 2007
• Est. completion date: January 2011

Study information

• Verified date: February 2019
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 335
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Programming (CRT-D, ICD OptiVol® and Cardiac Compass® )
OptiVol® Fluid status Monitoring with Cardiac Compass

Locations

Country	Name	City	State
Netherlands	Medtronic Bakken Research Center	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

van Veldhuisen DJ, Braunschweig F, Conraads V, Ford I, Cowie MR, Jondeau G, Kautzner J, Aguilera RM, Lunati M, Yu CM, Gerritse B, Borggrefe M; DOT-HF Investigators. Intrathoracic impedance monitoring, audible patient alerts, and outcome in patients with h — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	14.9 ± 5.4 months