Integrated Telemonitoring and Nurse Support Evaluation (INTENSE-HF)

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: Chronic Heart Failure
• Intervention / Treatment: Other: control; Other: telemonitoring

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

• Study Contact: Name: Friedrich M Fruhwald, MD; Phone Number: 12544 +43-316-385; Email: friedrich.fruhwald@medunigraz.at
• Study Contact Backup: Name: Daniel Scherr, MD; Phone Number: 12544 +43-316-385; Email: daniel.scherr@medunigraz.at

Study Locations

• Austria
  • Graz, Austria, 8036
    • Recruiting
    • Medical University
    • Contact: Friedrich M Fruhwald, MD; Phone Number: 12544 +43-316-385; Email: friedrich.fruhwald@medunigraz.at
    • Contact: Daniel Scherr, MD; Phone Number: 12544 +43-316-385; Email: daniel.scherr@medunigraz.at
    • Principal Investigator: Friedrich M Fruhwald, MD
    • Sub-Investigator: Daniel Scherr, MD

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	outcome assessment will be done by a blinded committee	12 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
exploratory endpoint	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

• 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

Helpful Links

• website of the Ludwig Boltzmann Institute for translational heart failure research

Study record dates

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: telemonitoring
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 24-537 ex 11/12