One Heart to Care for (1H2C4)

February 10, 2021 updated by: Pieter Vandervoort, Hasselt University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Genk, Belgium, 3600
        • Ziekenhuis Oost-Limburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Telemonitoring group
Additional telemonitoring devices: Blood Pressure Monitor, medication dispenser, telemonitoring technology
Device: 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 Names:
  • Telemedicine
  • remote monitoring
  • remote follow-up
NO_INTERVENTION: Control group
usual care, without telemonitoring

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
week 12
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
week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Medication titration
Time Frame: up to one year
Mean doses ACE-I/angiotensin receptor blockers (ARB) en BB after 6 months
up to one year
All-cause mortality
Time Frame: Up to one year
All-cause mortality
Up to one year
All cardio-related hospitalisations (number and time)
Time Frame: Up to one year
  • Arrythmogenic nature
  • Ischemic nature
  • Heart failure nature
  • Valvular/surgical nature
  • Elektrofysiological nature (implantation ICD, CRT,…)
Up to one year
All heart failure hospitalisations
Time Frame: Up to one year
  • Treatment with (whether or not intravenous) diuretic therapy
  • Treatment with hemodynamic guided therapy (vasodilators)
  • Treatment with intravenous inotropics
Up to one year
Number of medical practitioner-patient contacts
Time Frame: Up to one year
  • In hospital (medical record)
  • At patient home (WGK)
Up to one year
Number of (telephone) contacts, registered by the heart failure nurse
Time Frame: Up to one year
Number of (telephone) contacts, registered by the heart failure nurse
Up to one year
Number of (telephone) contacts for the encouragement of medication compliance
Time Frame: Up to one year
Number of (telephone) contacts for the encouragement of medication compliance
Up to one year
Evolution of heart failure and comorbidities
Time Frame: up to one year
  • 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
up to one year
Quality of life according to the HeartQoL questionnaire
Time Frame: day 1, month 12
day 1, month 12
Satisfaction survey
Time Frame: month 12
Satisfaction survey about the received care (anonymous)
month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hasselt University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ziekenhuis Oost-Limburg
WGK Limburg

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pieter Vandervoort, prof. dr., Ziekenhuis Oost-Limburg
  • Study Director: Brenda Aendekerk, MSc, Wit Gele Kruis Limburg, Genk, Belgium
  • Study Director: Valerie Storms, dr., Hasselt University
  • Principal Investigator: Lars Grieten, dr., Hasselt University
  • Study Chair: Christophe Smeets, MSc, Hasselt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 13/085U

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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