Chronic Heart FailureINTENSE-HFNCT01700218
Integrated Telemonitoring and Nurse Support Evaluation
A study testing telemonitoring in people with Chronic Heart Failure, run by Medical University of Graz at 1 site in Austria.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- telemonitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2012to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University
Graz, 8036
Friedrich M Fruhwald, MD, +43-316-385 ext. 12544, friedrich.fruhwald@medunigraz.at
Daniel Scherr, MD, +43-316-385 ext. 12544, daniel.scherr@medunigraz.at
About this study
Official title: Integrated Telemonitoring and Nurse Support Evaluation in Heart Failure
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
Read the 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.
- Conditions
- Chronic Heart Failure
- Being tested
- telemonitoring, control
- Keywords
- telemonitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telemonitoringOther
controlOther
| Study group | Role | What they receive |
|---|---|---|
| telemonitoring | Other | 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 Receives: Other: telemonitoring |
| control | Other | patients in the control arm will not record any vital parameter Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality and hospitalization for worsening heart failure
outcome assessment will be done by a blinded committee
Measured: 12 months
Secondary outcomes (1)
days alive and out of hospital
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionApr 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig Boltzmann Institute for translational heart failure research, AIT Austrian Institute of Technology GmbH
- Responsible party
- Sponsor
- Investigators
- Friedrich M Fruhwald, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700218
- Sponsor's protocol ID
- 24-537 ex 11/12
- Acronym
- INTENSE-HF
- Status last verified
- Nov 2014
- First submitted
- 2 Oct 2012
- Last updated
- 25 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Telemonitoring and Nurse Support Evaluation in Heart Failure
- ClinicalTrials.gov ID
- NCT01700218
- Acronym / sponsor ID
- INTENSE-HF / 24-537 ex 11/12
- Conditions
- Chronic Heart Failure
- Keywords
- telemonitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Ludwig Boltzmann Institute for translational heart failure research, AIT Austrian Institute of Technology GmbH
- Study start
- Oct 2012
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 4 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| telemonitoring | Other | Other: telemonitoringpatients 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 |
| control | Other | Other: controlpatients in the control arm will not record any vital parameter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telemonitoring | Other | telemonitoring |
| control | Other | control |
Primary outcome
all cause mortality and hospitalization for worsening heart failure
Time frame: 12 months
outcome assessment will be done by a blinded committee
1 secondary outcome
days alive and out of hospital
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Friedrich M Fruhwald, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telemonitoring in people with Chronic Heart Failure, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Friedrich M Fruhwald, MD (+43-316-385 ext. 12544, friedrich.fruhwald@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality and hospitalization for worsening heart failure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2014.