Integrated Telemonitoring and Nurse Support Evaluation | NCT01700218

Studies
Integrated Telemonitoring and Nurse Support Evaluation

NCT01700218

Sponsor

Medical University of Graz

Status

Unknown status

Last Update Posted

Nov 25, 2014Estimated

Enrollment

350Estimated

Phase

Not Applicable

Conditions

Chronic Heart Failure

Interventions

telemonitoring
control

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Apr 2015Estimated

Completion Date

Oct 2015Estimated

First Submitted Date

Oct 2, 2012

First Submission Date that Met QC Criteria

Oct 2, 2012

First Posted Date

Oct 4, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 23, 2014

Last Update Posted Date

Nov 25, 2014Estimated

Name	Class
Ludwig Boltzmann Institute for translational heart failure research	UNKNOWN
AIT Austrian Institute of Technology GmbH	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

350Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Other: telemonitoring
control	Other	patients in the control arm will not record any vital parameter	Other: control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
telemonitoring	Other		telemonitoring
control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
all cause mortality and hospitalization for worsening heart failure	outcome assessment will be done by a blinded committee	12 months

Secondary Outcomes

Measure	Description	Time Frame
days alive and out of hospital		12 months

Other Outcomes

Measure	Description	Time Frame
exploratory endpoint	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	12 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Friedrich M Fruhwald, MD	Contact	+43-316-385	12544	friedrich.fruhwald@medunigraz.at
Daniel Scherr, MD	Contact	+43-316-385	12544	daniel.scherr@medunigraz.at

Overall Officials

Name	Affiliation	Role
Friedrich M Fruhwald, MD	Medical University of Graz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University	Recruiting	Graz		8036	Austria