Integrated Telemonitoring and Nurse Support Evaluation (INTENSE-HF)

November 23, 2014 updated by: Medical University of Graz

Integrated Telemonitoring and Nurse Support Evaluation in Heart Failure

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Friedrich M Fruhwald, MD
        • Sub-Investigator:
          • Daniel Scherr, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: control
patients in the control arm will not record any vital parameter
Other: control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all cause mortality and hospitalization for worsening heart failure
Time Frame: 12 months
outcome assessment will be done by a blinded committee
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
days alive and out of hospital
Time Frame: 12 months
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Collaborators

AIT Austrian Institute of Technology GmbH
Ludwig Boltzmann Institute for translational heart failure research

Investigators

  • Principal Investigator: Friedrich M Fruhwald, MD, Medical University of Graz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

April 1, 2015

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

October 2, 2012

First Submitted That Met QC Criteria

October 2, 2012

First Posted (Estimate)

October 4, 2012

Study Record Updates

Last Update Posted (Estimate)

November 25, 2014

Last Update Submitted That Met QC Criteria

November 23, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-537 ex 11/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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