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Integrated Telemonitoring and Nurse Support Evaluation (INTENSE-HF)

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ClinicalTrials.gov Identifier: NCT01700218
Recruitment Status : Unknown
Verified November 2014 by Medical University of Graz.
Recruitment status was:  Recruiting
First Posted : October 4, 2012
Last Update Posted : November 25, 2014
Sponsor:
Collaborators:
Ludwig Boltzmann Institute for translational heart failure research
AIT Austrian Institute of Technology GmbH
Information provided by (Responsible Party):
Medical University of Graz

Study Description
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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

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Other: telemonitoring Other: control Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Integrated Telemonitoring and Nurse Support Evaluation in Heart Failure
Study Start Date : October 2012
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
telemonitoring
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
 Other: telemonitoring
control
patients in the control arm will not record any vital parameter
 Other: control


Outcome Measures
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Primary Outcome Measures :
  1. all cause mortality and hospitalization for worsening heart failure [ Time Frame: 12 months ]
    outcome assessment will be done by a blinded committee


Secondary Outcome Measures :
  1. days alive and out of hospital [ Time Frame: 12 months ]

Other Outcome Measures:
  1. exploratory endpoint [ Time Frame: 12 months ]
    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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700218


Contacts
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Contact: Friedrich M Fruhwald, MD +43-316-385 ext 12544 friedrich.fruhwald@medunigraz.at
Contact: Daniel Scherr, MD +43-316-385 ext 12544 daniel.scherr@medunigraz.at

Locations
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Austria
Medical University Recruiting
Graz, Austria, 8036
Contact: Friedrich M Fruhwald, MD    +43-316-385 ext 12544    friedrich.fruhwald@medunigraz.at   
Contact: Daniel Scherr, MD    +43-316-385 ext 12544    daniel.scherr@medunigraz.at   
Principal Investigator: Friedrich M Fruhwald, MD         
Sub-Investigator: Daniel Scherr, MD         
Sponsors and Collaborators
Medical University of Graz
Ludwig Boltzmann Institute for translational heart failure research
AIT Austrian Institute of Technology GmbH
Investigators
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Principal Investigator: Friedrich M Fruhwald, MD Medical University of Graz
More Information
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Additional Information:

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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01700218    
Other Study ID Numbers: 24-537 ex 11/12
First Posted: October 4, 2012    Key Record Dates
Last Update Posted: November 25, 2014
Last Verified: November 2014
Keywords provided by Medical University of Graz:
telemonitoring
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases