Integrated Telemonitoring and Nurse Support Evaluation (INTENSE-HF)

Medical University of Graz

Status: Unknown

Conditions: Chronic Heart Failure

Treatments: Other: control; Other: telemonitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT01700218

24-537 ex 11/12

Details and patient eligibility

About

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

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

telemonitoring

Other group

Description:

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

Treatment:

Other: telemonitoring

control

Other group

Description:

patients in the control arm will not record any vital parameter

Treatment:

Other: control