Integrated Telemonitoring and Nurse Support Evaluation (INTENSE-HF)
Primary Purpose
Chronic Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
telemonitoring
control
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Heart Failure focused on measuring telemonitoring
Eligibility Criteria
Inclusion Criteria:
- acute systolic heart failure with admission for at least 4 consecutive days
- treatment with an ACE-inhibitor/angiotensin receptor blocker, beta-blocker, mineralocorticoid receptor antagonist according to current ESC-guidelines
- treatment with a loop diuretic
- stable renal function (eGFR according to MDRD of at least 30ml)
- written informed consent
- minimum age of 18 years
Exclusion Criteria:
- unstable coronary artery disease with revascularisation of any type within the last two months
- planned revascularisation or operation for valvular heart disease within the next 6 months
- planned heart transplantation
- uncontrolled hypertension
- active myocarditis
- malignant disease with a life expectancy of less than 18 months
- chronic use of high-dose NSAID or COX-2-inhibitors
- psychiatric disorders that make it unlikely to understand the protocol
- participation in an other randomized trial
- inability to operate a smartphone
Sites / Locations
- Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
telemonitoring
control
Arm Description
patients in the telemonitoring arm will record vital parameters (blood pressure, heart rate, body weight) and transmit these parameters together with wellbeing and daily dose of heart failure medication
patients in the control arm will not record any vital parameter
Outcomes
Primary Outcome Measures
all cause mortality and hospitalization for worsening heart failure
outcome assessment will be done by a blinded committee
Secondary Outcome Measures
days alive and out of hospital
Full Information
NCT ID
NCT01700218
First Posted
October 2, 2012
Last Updated
November 23, 2014
Sponsor
Medical University of Graz
Collaborators
Ludwig Boltzmann Institute for translational heart failure research, AIT Austrian Institute of Technology GmbH
1. Study Identification
Unique Protocol Identification Number
NCT01700218
Brief Title
Integrated Telemonitoring and Nurse Support Evaluation
Acronym
INTENSE-HF
Official Title
Integrated Telemonitoring and Nurse Support Evaluation in Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
Collaborators
Ludwig Boltzmann Institute for translational heart failure research, AIT Austrian Institute of Technology GmbH
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to test a new medical device for optimizing treatment of heart failure and compare its effect on outcome of patients with a recent hospitalization for worsening heart failure
Detailed Description
Patients after an episode of acute heart failure have an increased risk of rehospitalisation and impaired prognosis for survival. Neither a sole mobile nurse support nor a sole telemonitoring system has been able to provide consistent data on a beneficial influence on prognosis. Furthermore, the influence of frequent measurements of NT-pro-BNP in a home setting of heart failure patients has not been investigated so far.
This study will test a new medical device (software) for optimizing treatment of heart failure patients and evaluate its impact on outcome of these patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
telemonitoring
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
telemonitoring
Arm Type
Other
Arm Description
patients in the telemonitoring arm will record vital parameters (blood pressure, heart rate, body weight) and transmit these parameters together with wellbeing and daily dose of heart failure medication
Arm Title
control
Arm Type
Other
Arm Description
patients in the control arm will not record any vital parameter
Intervention Type
Other
Intervention Name(s)
telemonitoring
Intervention Type
Other
Intervention Name(s)
control
Primary Outcome Measure Information:
Title
all cause mortality and hospitalization for worsening heart failure
Description
outcome assessment will be done by a blinded committee
Time Frame
12 months
Secondary Outcome Measure Information:
Title
days alive and out of hospital
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
exploratory endpoint
Description
The exploratory endpoint will focus on the percentage of optimal dosing (according to current ESC-guidelines) for ACE-inhibitors, angiotensin receptor blockers and beta-blockers
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
acute systolic heart failure with admission for at least 4 consecutive days
treatment with an ACE-inhibitor/angiotensin receptor blocker, beta-blocker, mineralocorticoid receptor antagonist according to current ESC-guidelines
treatment with a loop diuretic
stable renal function (eGFR according to MDRD of at least 30ml)
written informed consent
minimum age of 18 years
Exclusion Criteria:
unstable coronary artery disease with revascularisation of any type within the last two months
planned revascularisation or operation for valvular heart disease within the next 6 months
planned heart transplantation
uncontrolled hypertension
active myocarditis
malignant disease with a life expectancy of less than 18 months
chronic use of high-dose NSAID or COX-2-inhibitors
psychiatric disorders that make it unlikely to understand the protocol
participation in an other randomized trial
inability to operate a smartphone
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Friedrich M Fruhwald, MD
Phone
+43-316-385
Ext
12544
Email
friedrich.fruhwald@medunigraz.at
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Scherr, MD
Phone
+43-316-385
Ext
12544
Email
daniel.scherr@medunigraz.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Friedrich M Fruhwald, MD
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Friedrich M Fruhwald, MD
Phone
+43-316-385
Ext
12544
Email
friedrich.fruhwald@medunigraz.at
First Name & Middle Initial & Last Name & Degree
Daniel Scherr, MD
Phone
+43-316-385
Ext
12544
Email
daniel.scherr@medunigraz.at
First Name & Middle Initial & Last Name & Degree
Friedrich M Fruhwald, MD
First Name & Middle Initial & Last Name & Degree
Daniel Scherr, MD
12. IPD Sharing Statement
Links:
URL
http://heart.lbg.ac.at
Description
website of the Ludwig Boltzmann Institute for translational heart failure research
Learn more about this trial
Integrated Telemonitoring and Nurse Support Evaluation
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