Integrated Telemonitoring and Nurse Support Evaluation in Heart Failure
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Chronic Heart Failure
- Sponsor
- Medical University of Graz
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- all cause mortality and hospitalization for worsening heart failure
- Last Updated
- 11 years ago
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.
Investigators
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
Outcomes
Primary Outcomes
all cause mortality and hospitalization for worsening heart failure
Time Frame: 12 months
outcome assessment will be done by a blinded committee
Secondary Outcomes
- days alive and out of hospital(12 months)