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

NCT00480077 | Terminated Phase 4 Results DMC

• 1 other identifier: 20061016-V2
• Study Type: interventional
• Target: 335
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure

Keywords

Heart Failure, randomized, OptiVol® Fluid status monitoring

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Access Arm

EXPERIMENTAL

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® )

Control arm

ACTIVE COMPARATOR

HF subjects managed with standard clinical assessment

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

Interventions

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

OptiVol® Fluid status Monitoring with Cardiac Compass

Also known as: OptiVol® audible alert

Access Arm; Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (1)

Medtronic Bakken Research Center

Maastricht, 6229 GW, Netherlands

Location

Related Publications (2)

• 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 heart failure. Circulation. 2011 Oct 18;124(16):1719-26. doi: 10.1161/CIRCULATIONAHA.111.043042. Epub 2011 Sep 19.

  PMID: 21931078 RESULT

• Conraads VM, Spruit MA, Braunschweig F, Cowie MR, Tavazzi L, Borggrefe M, Hill MR, Jacobs S, Gerritse B, van Veldhuisen DJ. Physical activity measured with implanted devices predicts patient outcome in chronic heart failure. Circ Heart Fail. 2014 Mar 1;7(2):279-87. doi: 10.1161/CIRCHEARTFAILURE.113.000883. Epub 2014 Feb 11.

  PMID: 24519908 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Director CRDM
• Organization: Medtronic Bakken Research Center

31-43-3566813

Study Officials

• Prof. D.J. van Veldhuisen, MD

  Groningen University Hospital, The Netherlands

  STUDY CHAIR

• Prof. Dr. med. M. Borggrefe

  Ruprecht-Karls-Universität Heidelberg, Germany

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 29, 2007
• First Posted: May 30, 2007
• Study Start: March 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: July 2, 2025
• Results First Posted: February 19, 2019

Record last verified: 2019-02

Locations

NL (1)