Heart Failure1H2C4NCT04753398
One Heart to Care for
A study testing Blood Pressure Monitor, medication dispenser, telemonitoring technology in people with Heart Failure, run by Hasselt University at 1 site in Belgium.
Trial summary
This is an open randomized clinical trial with two study arms. One group, receiving usual care for heart failure, will be compared to another group, receiving usual care plus active telemonitoring interference. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Blood Pressure Monitor, medication dispenser, telemonitoring technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2014to Dec 2016
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Age ≥ 50
- 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.
Who cannot join
- Reversible form of heart failure
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: One Heart to Care for, Your Heart to Take Care of.
This is an open randomized clinical trial with two study arms. One group, receiving usual care for heart failure, will be compared to another group, receiving usual care plus active telemonitoring interference.
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.
- Conditions
- Heart Failure
- Being tested
- Blood Pressure Monitor, medication dispenser, telemonitoring technology
- Keywords
- Heart Failure, Telemonitoring, medication up titration, automatic blood pressure device, medication dispenser
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Pressure Monitor, medication dispenser, telemonitoring technologyDevice
Also called Telemedicine, remote monitoring, remote follow-up
The telemonitoring interference in the telemonitoring arm consists of an automatic blood pressure device and medication dispenser that transmit data to a central platform.
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring group | Experimental | Additional telemonitoring devices: Blood Pressure Monitor, medication dispenser, telemonitoring technology Receives: Device: Blood Pressure Monitor, medication dispenser, telemonitoring technology |
| Control group | No intervention | usual care, without telemonitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean medication doses
Define whether the mean medication doses of angiotensin-converting-enzyme inhibitor (ACE-I) and bètablockers (BB) in the group with telemonitoring is higher than in the group with usual care (without telemonitoring) after 12 weeks.
Measured: week 12
Mean medication doses
Define whether the mean medication doses of angiotensin-converting-enzyme inhibitor (ACE-I) and bètablockers (BB) in the group with telemonitoring is higher than in the group with usual care (without telemonitoring) after 6 months
Measured: week 24
Secondary outcomes (10)
Medication titration
Mean doses ACE-I/angiotensin receptor blockers (ARB) en BB after 6 months
Measured: up to one year
All-cause mortality
All-cause mortality
Measured: Up to one year
All cardio-related hospitalisations (number and time)
- Arrythmogenic nature
- Ischemic nature
- Heart failure nature
- Valvular/surgical nature
- Elektrofysiological nature (implantation ICD, CRT,…)
Measured: Up to one year
All heart failure hospitalisations
- Treatment with (whether or not intravenous) diuretic therapy
- Treatment with hemodynamic guided therapy (vasodilators)
- Treatment with intravenous inotropics
Measured: Up to one year
Number of medical practitioner-patient contacts
- In hospital (medical record)
- At patient home (WGK)
Measured: Up to one year
Number of (telephone) contacts, registered by the heart failure nurse
Number of (telephone) contacts, registered by the heart failure nurse
Measured: Up to one year
Number of (telephone) contacts for the encouragement of medication compliance
Number of (telephone) contacts for the encouragement of medication compliance
Measured: Up to one year
Evolution of heart failure and comorbidities
- Blood collection with: kidney function determinations, electrolytes, heart markers (NT-proBNP)
- Echo parameters (cardiac output, LVEF, diameters end systolic and diastolic)
- Exercise stress tests (VO2max, maximal wattage, maximal heart rate)
- Weight, length, blood pressure, ECG
Measured: up to one year
Quality of life according to the HeartQoL questionnaire
Measured: day 1, month 12
Satisfaction survey
Satisfaction survey about the received care (anonymous)
Measured: month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study startJan 2014
- Primary completionDec 2015
- Study completionDec 2016
Why it stopped: No patients included
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg, WGK Limburg
- Responsible party
- Principal investigator, Pieter Vandervoort, Hasselt University
- Investigators
- Pieter Vandervoort, prof. dr., Principal investigator, Ziekenhuis Oost-LimburgBrenda Aendekerk, MSc, Study director, Wit Gele Kruis Limburg, Genk, BelgiumValerie Storms, dr., Study director, Hasselt UniversityLars Grieten, dr., Principal investigator, Hasselt UniversityChristophe Smeets, MSc, Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753398
- Sponsor's protocol ID
- 13/085U
- Acronym
- 1H2C4
- Status last verified
- Feb 2021
- First submitted
- 3 Mar 2014
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Heart to Care for, Your Heart to Take Care of.
- ClinicalTrials.gov ID
- NCT04753398
- Acronym / sponsor ID
- 1H2C4 / 13/085U
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Telemonitoring, medication up titration, automatic blood pressure device, medication dispenser
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients included
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg, WGK Limburg
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 15 Feb 2021 (actual)
- 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.
This is an open randomized clinical trial with two study arms. One group, receiving usual care for heart failure, will be compared to another group, receiving usual care plus active telemonitoring interference.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring group | Experimental | Device: Blood Pressure Monitor, medication dispenser, telemonitoring technologyAdditional telemonitoring devices: Blood Pressure Monitor, medication dispenser, telemonitoring technology |
| Control group | No intervention | –usual care, without telemonitoring |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- - Age ≥ 50
- 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:
- 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.
Key exclusion criteria (7 listed)
- Reversible form of heart failure
- 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)
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 |
|---|---|---|
| Blood Pressure Monitor, medication dispenser, telemonitoring technologyAlso: Telemedicine, remote monitoring, remote follow-upThe telemonitoring interference in the telemonitoring arm consists of an automatic blood pressure device and medication dispenser that transmit data to a central platform. | Device | Telemonitoring group |
Primary outcome
Mean medication doses
Time frame: week 12
Define whether the mean medication doses of angiotensin-converting-enzyme inhibitor (ACE-I) and bètablockers (BB) in the group with telemonitoring is higher than in the group with usual care (without telemonitoring) after 12 weeks.
Mean medication doses
Time frame: week 24
Define whether the mean medication doses of angiotensin-converting-enzyme inhibitor (ACE-I) and bètablockers (BB) in the group with telemonitoring is higher than in the group with usual care (without telemonitoring) after 6 months
10 secondary outcomes
Medication titration
Time frame: up to one year
All-cause mortality
Time frame: Up to one year
All cardio-related hospitalisations (number and time)
Time frame: Up to one year
All heart failure hospitalisations
Time frame: Up to one year
Number of medical practitioner-patient contacts
Time frame: Up to one year
Number of (telephone) contacts, registered by the heart failure nurse
Time frame: Up to one year
Number of (telephone) contacts for the encouragement of medication compliance
Time frame: Up to one year
Evolution of heart failure and comorbidities
Time frame: up to one year
Quality of life according to the HeartQoL questionnaire
Time frame: day 1, month 12
Satisfaction survey
Time frame: month 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
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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.
Pieter Vandervoort, prof. dr. principal investigator
Ziekenhuis Oost-Limburg
Brenda Aendekerk, MSc study director
Wit Gele Kruis Limburg, Genk, Belgium
Valerie Storms, dr. study director
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Pressure Monitor, medication dispenser, telemonitoring technology in people with Heart Failure, run by Hasselt University at 1 site in Belgium.
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 8 inclusion and 7 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: withdrawn, as of the sponsor's last update on 15 Feb 2021. 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 Belgium. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean medication doses (time frame: week 12). The study lists 2 primary outcomes in all. 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 15 Feb 2021.