Integrated Telemonitoring and Nurse Support Evaluation

Study Overview
=================
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.

Official Title
-----------------
Integrated Telemonitoring and Nurse Support Evaluation in Heart Failure

Conditions
-----------------
Chronic Heart Failure

Intervention / Treatment
-----------------
* Other: telemonitoring
* Other: control


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: telemonitoring<br>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<br> <br> |
| Other: control<br>patients in the control arm will not record any vital parameter | Other: control<br> <br> |

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 | Measure Description | Time Frame |
| --- | --- | --- |
| days alive and out of hospital |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
telemonitoring