Integrated Telemonitoring and Nurse Support Evaluation
INTENSE-HF
1 other identifier
interventional
350
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 2, 2012
CompletedFirst Posted
Study publicly available on registry
October 4, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedNovember 25, 2014
November 1, 2014
2.5 years
October 2, 2012
November 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
all cause mortality and hospitalization for worsening heart failure
outcome assessment will be done by a blinded committee
12 months
Secondary Outcomes (1)
days alive and out of hospital
12 months
Other Outcomes (1)
exploratory endpoint
12 months
Study Arms (2)
telemonitoring
OTHERpatients 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
OTHERpatients in the control arm will not record any vital parameter
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University
Graz, 8036, Austria
Study Officials
- PRINCIPAL INVESTIGATOR
Friedrich M Fruhwald, MD
Medical University of Graz
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2012
First Posted
October 4, 2012
Study Start
October 1, 2012
Primary Completion
April 1, 2015
Study Completion
October 1, 2015
Last Updated
November 25, 2014
Record last verified: 2014-11