Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2014-01-31
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
When leaving the hospital, the usual care arm receives a document with a predefined medication scheme and advice for the general practitioner (like it is currently done in usual care). Besides the normal consultations at 2 and 5 weeks, no active interactions take place between the study nurse and the patient.
The telemonitoring interference in the other study arm consists of an automatic blood pressure device and medication dispenser that transmit data to a central platform. During the first 12 weeks, the nurse of the call center will give incentive for medication up titration on the basis of the available data. Before up titration can be done, the patient needs to take blood pressure measurements 3 times in the morning and 3 times in the evening and at least 6 measurements a week.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Implementation and Cost-evaluation of a Smartphone-based Telemonitoring and Digital Support in Patients With HF
NCT05487365
Impact of Beta-blockers on Physical Function in HFpEF
NCT04767061
A Two-way Communication System to Coach Elderly Patients With Heart Failure
NCT03294811
Effectiveness of a Website and Telemonitoring in Patients With Heart Failure.
NCT01755988
Remote Monitoring of Ambulatory Intravenous Diuretics in Heart Failure
NCT05193084
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Telemonitoring group
Additional telemonitoring devices: Blood Pressure Monitor, medication dispenser, telemonitoring technology
Blood Pressure Monitor, medication dispenser, telemonitoring technology
The telemonitoring interference in the telemonitoring arm consists of an automatic blood pressure device and medication dispenser that transmit data to a central platform.
Control group
usual care, without telemonitoring
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Blood Pressure Monitor, medication dispenser, telemonitoring technology
The telemonitoring interference in the telemonitoring arm consists of an automatic blood pressure device and medication dispenser that transmit data to a central platform.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient has to be followed in Ziekenhuis Oost-Limburg or Jessa Ziekenhuis Hasselt
* The patient has to be able to live independently or in a service flat
* The diagnosis of heart failure or severe myocardial infarction has to be done after September 1, 2013 according to:
* Left ventricular ejection fraction (LVEF) \<40%
* eGFR\>30ml/min/kg
* Treatment minimally with ACE-I and BB
* The general practitioner had to give his approval for the installation of telemonitoring On the basis of an interview between the heart failure nurse and patient, one will decide if the patient is eligibil to join the study. The patient also needs to speak sufficient Dutch to be communicative about his/her medical condition.
Exclusion Criteria
* Heart failure due to severe aortic stenosis
* eGFR less than 30ml/min/kg
* Presence of a cardiac resynchronization therapy (CRT) device
* Palliative status following the RIZIV guidelines or according to the assessment of the cardiologist (\<1 year)
* Patients staying in a nursing or retirement home
* Active treatment with either ACE-I/ARB or BB
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ziekenhuis Oost-Limburg
OTHER
WGK Limburg
UNKNOWN
Hasselt University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pieter Vandervoort
prof. dr.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pieter Vandervoort, prof. dr.
Role: PRINCIPAL_INVESTIGATOR
Ziekenhuis Oost-Limburg
Brenda Aendekerk, MSc
Role: STUDY_DIRECTOR
Wit Gele Kruis Limburg, Genk, Belgium
Valerie Storms, dr.
Role: STUDY_DIRECTOR
Hasselt University
Lars Grieten, dr.
Role: PRINCIPAL_INVESTIGATOR
Hasselt University
Christophe Smeets, MSc
Role: STUDY_CHAIR
Hasselt University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ziekenhuis Oost-Limburg
Genk, , Belgium
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
13/085U
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.