Integrated Telemonitoring and Nurse Support Evaluation

Chronic Heart Failure Clinical Trial

— INTENSE-HF  

Official title:

Integrated Telemonitoring and Nurse Support Evaluation in Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01700218
• Other study ID #: 24-537 ex 11/12
• Status: Recruiting
• Phase: N/A
• First received: October 2, 2012
• Last updated: November 23, 2014
• Start date: October 2012
• Est. completion date: October 2015

Study information

• Verified date: November 2014
• Source: Medical University of Graz
• Contact: Friedrich M Fruhwald, MD
• Phone: +43-316-385
• Email: friedrich.fruhwald[@]medunigraz.at
• Is FDA regulated: No
• Health authority: Austria: Austrian Medicines and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: October 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Other:
• telemonitoring

• control

Locations

Country	Name	City	State
Austria	Medical University	Graz

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of Graz	AIT Austrian Institute of Technology GmbH, Ludwig Boltzmann Institute for translational heart failure research

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	all cause mortality and hospitalization for worsening heart failure	outcome assessment will be done by a blinded committee	12 months	No
Secondary	days alive and out of hospital		12 months	No

External Links

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