Chronic Heart Failure
Conditions
Keywords
telemonitoring
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.
Interventions
OTHERtelemonitoring
OTHERcontrol
Sponsors
Ludwig Boltzmann Institute for translational heart failure research
AIT Austrian Institute of Technology GmbH
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| all cause mortality and hospitalization for worsening heart failure | 12 months | outcome assessment will be done by a blinded committee |
Secondary
| Measure | Time frame |
|---|---|
| days alive and out of hospital | 12 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| exploratory endpoint | 12 months | 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 |
Countries
Austria
Contacts
Primary ContactFriedrich M Fruhwald, MD
Backup ContactDaniel Scherr, MD
Outcome results
None listed