Integrated Telemonitoring and Nurse Support Evaluation

Not Applicable

• Conditions: Chronic Heart Failure
• Interventions: Other: control; Other: telemonitoring

• 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

Arm && Interventions

Group	Intervention	Description
control	control	patients in the control arm will not record any vital parameter
telemonitoring	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

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