Suspended

INTENSE-HFTelemonitoring and Nurse Support Impact on Heart Failure Treatment

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Study Aim

This study aims to evaluate the impact of telemonitoring and nurse support on heart failure treatment, focusing on reducing all cause mortality and hospitalization for worsening heart failure, as assessed by a blinded committee.

What is being tested

telemonitoring

+ control

Other
Who is being recruted

Over 18 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorMedical University of Graz
Study ContactFriedrich M Fruhwald, MDMore contacts
Last updated: November 25, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01700218
Principal SponsorMedical University of Graz
Study ContactFriedrich M Fruhwald, MDMore contacts
Last updated: November 25, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

350 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

6 inclusion criteria required to participate
acute systolic heart failure with admission for at least 4 consecutive days
minimum age of 18 years
stable renal function (eGFR according to MDRD of at least 30ml)
treatment with a loop diuretic
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10 exclusion criteria prevent from participating
active myocarditis
chronic use of high-dose NSAID or COX-2-inhibitors
inability to operate a smartphone
malignant disease with a life expectancy of less than 18 months
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

patients in the control arm will not record any vital parameter

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Medical University

Graz, AustriaOpen Medical University in Google Maps
SuspendedOne Study Center