Integrated Telemonitoring and Nurse Support Evaluation (INTENSE-HF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Medical University of Graz
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
ClinicalTrials.gov Identifier:
NCT01700218
First received: October 2, 2012
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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 ] [ Designated as safety issue: No ]
    outcome assessment will be done by a blinded committee


Secondary Outcome Measures:
  • days alive and out of hospital [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • exploratory endpoint [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01700218

Contacts
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
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
Principal Investigator: Friedrich M Fruhwald, MD Medical University of Graz
  More Information

Additional Information:
No publications provided

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01700218     History of Changes
Other Study ID Numbers: 24-537 ex 11/12
Study First Received: October 2, 2012
Last Updated: October 28, 2013
Health Authority: Austria: Austrian Medicines and Medical Devices Agency

Keywords provided by Medical University of Graz:
telemonitoring

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 20, 2014