Integrated Telemonitoring and Nurse Support Evaluation (INTENSE-HF)
This study is currently recruiting participants.
Verified December 2012 by Medical University of Graz
Sponsor:
Medical University of Graz
Collaborators:
Ludwig Boltzmann Institute for translational heart failure research
Austrian Institute of Technology (AIT)
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01700218
First received: October 2, 2012
Last updated: December 3, 2012
Last verified: December 2012
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Purpose
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
| Condition | Intervention |
|---|---|
|
Chronic Heart Failure |
Other: telemonitoring Other: control |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Integrated Telemonitoring and Nurse Support Evaluation in Heart Failure |
Resource links provided by NLM:
Further study details as provided by Medical University of Graz:
Primary Outcome Measures:
- all cause mortality and hospitalization for worsening heart failure [ Time Frame: 12 months ] [ Designated as safety issue: No ]outcome assessment will be done by a blinded committee
Secondary Outcome Measures:
- days alive and out of hospital [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Other Outcome Measures:
- exploratory endpoint [ Time Frame: 12 months ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 350 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
telemonitoring
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 |
|
control
patients in the control arm will not record any vital parameter
|
Other: control |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700218
Contacts
| Contact: Friedrich M Fruhwald, MD | +43-316-385 ext 12544 | friedrich.fruhwald@medunigraz.at |
| Contact: Daniel Scherr, MD | +43-316-385 ext 12544 | daniel.scherr@medunigraz.at |
Locations
| Austria | |
| Medical University | Recruiting |
| Graz, Austria, 8036 | |
| Contact: Friedrich M Fruhwald, MD +43-316-385 ext 12544 friedrich.fruhwald@medunigraz.at | |
| Contact: Daniel Scherr, MD +43-316-385 ext 12544 daniel.scherr@medunigraz.at | |
| Principal Investigator: Friedrich M Fruhwald, MD | |
| Sub-Investigator: Daniel Scherr, MD | |
Sponsors and Collaborators
Medical University of Graz
Ludwig Boltzmann Institute for translational heart failure research
Austrian Institute of Technology (AIT)
Investigators
| Principal Investigator: | Friedrich M Fruhwald, MD | Medical University of Graz |
More Information
Additional Information:
No publications provided
| Responsible Party: | Medical University of Graz |
| ClinicalTrials.gov Identifier: | NCT01700218 History of Changes |
| Other Study ID Numbers: | 24-537 ex 11/12 |
| Study First Received: | October 2, 2012 |
| Last Updated: | December 3, 2012 |
| Health Authority: | Austria: Austrian Medicines and Medical Devices Agency |
Keywords provided by Medical University of Graz:
|
telemonitoring |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013