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Integrated Telemonitoring and Nurse Support Evaluation (INTENSE-HF)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2014 by Medical University of Graz.
Recruitment status was:  Recruiting
Ludwig Boltzmann Institute for translational heart failure research
AIT Austrian Institute of Technology GmbH
Information provided by (Responsible Party):
Medical University of Graz Identifier:
First received: October 2, 2012
Last updated: November 23, 2014
Last verified: November 2014
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 Intervention
Chronic Heart Failure
Other: telemonitoring
Other: control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Integrated Telemonitoring and Nurse Support Evaluation in Heart Failure

Resource links provided by NLM:

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • 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:
  • days alive and out of hospital [ Time Frame: 12 months ]

Other Outcome Measures:
  • 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

Estimated Enrollment: 350
Study Start Date: October 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
patients in the control arm will not record any vital parameter
Other: control

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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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Please refer to this study by its identifier: NCT01700218

Medical University
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Ludwig Boltzmann Institute for translational heart failure research
AIT Austrian Institute of Technology GmbH
Principal Investigator: Friedrich M Fruhwald, MD Medical University of Graz
  More Information

Additional Information:
Responsible Party: Medical University of Graz Identifier: NCT01700218     History of Changes
Other Study ID Numbers: 24-537 ex 11/12 
Study First Received: October 2, 2012
Last Updated: November 23, 2014

Keywords provided by Medical University of Graz:

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on February 20, 2017