Integrated Telemonitoring and Nurse Support Evaluation

Not Applicable

• Conditions: Chronic Heart Failure

• Registration Number: NCT01700218
• Lead Sponsor: Medical University of Graz

Brief 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

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 Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-02
• Study First Submitted QC: 2012-10-02
• Study First Posted: 2012-10-04
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-23
• Last Update Posted: 2014-11-25
• Primary Completion: 2015-04
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
all cause mortality and hospitalization for worsening heart failure	12 months	outcome assessment will be done by a blinded committee

Secondary Outcome Measures

Name	Time	Method
days alive and out of hospital	12 months

Trial Locations

Locations (1)

Medical University; 🇦🇹 Graz, Austria