Clinical trial NCT00480077: Diagnostic Outcome Trial in Heart Failure (DOT-HF Trial)
Official title: Diagnostic Outcome Trial in Heart Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Heart Failure
Keywords: Heart Failure, randomized, OptiVol® Fluid status monitoring
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2007-05-30
Enrollment: 335
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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"
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Number of Participants With Combined End Point of All-cause Mortality or Heart Failure Hospitalization
timeFrame: 14.9 ± 5.4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Medtronic Bakken Research Center
Study officials:
affiliation: Groningen University Hospital, The Netherlands
name: Prof. D.J. van Veldhuisen, MD
role: STUDY_CHAIR
affiliation: Ruprecht-Karls-Universität Heidelberg, Germany
name: Prof. Dr. med. M. Borggrefe
role: STUDY_CHAIR
affiliation: Universitair Ziekenhuis Brussel
name: Prof. Dr. V. Conraads
role: PRINCIPAL_INVESTIGATOR
affiliation: Prince of Wales Hospital, Shatin, Hong Kong
name: Prof. C.M. Yu
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska University Hospital
name: Dr. F. Braunschweig
role: PRINCIPAL_INVESTIGATOR
affiliation: IKEM- Klinika Kardiologie, Czech Republic
name: Prof. Dr. J. Kautzner
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Bichat Claude Bernard, France
name: Prof. Dr. G. Jondeau
role: PRINCIPAL_INVESTIGATOR
affiliation: National Heart & Lung Institute, United Kingdom
name: Prof. Dr. M.R. Cowie
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General Universitario Gregorio Marañon, Spain
name: Dr. R. Muñoz-Aguilera
role: PRINCIPAL_INVESTIGATOR
affiliation: Robertson Center for Biostatistics, Scotland
name: Prof. I. Ford
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliera Niguarda Ca' Granda
name: Dr. M Lunati
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.