Clinical trial NCT04753398: One Heart to Care for
Official title: One Heart to Care for, Your Heart to Take Care of.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Telemonitoring
medication up titration
automatic blood pressure device
medication dispenser
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Ziekenhuis Oost-Limburg
name: WGK Limburg
First posted: 2021-02-15
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean medication doses
timeFrame: week 12
measure: Mean medication doses
timeFrame: week 24
Secondary outcomes:
measure: Medication titration
timeFrame: up to one year
measure: All-cause mortality
timeFrame: Up to one year
measure: All cardio-related hospitalisations (number and time)
timeFrame: Up to one year
measure: All heart failure hospitalisations
timeFrame: Up to one year
measure: Number of medical practitioner-patient contacts
timeFrame: Up to one year
measure: Number of (telephone) contacts, registered by the heart failure nurse
timeFrame: Up to one year
measure: Number of (telephone) contacts for the encouragement of medication compliance
timeFrame: Up to one year
measure: Evolution of heart failure and comorbidities
timeFrame: up to one year
measure: Quality of life according to the HeartQoL questionnaire
timeFrame: day 1, month 12
measure: Satisfaction survey
timeFrame: month 12
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Pieter Vandervoort, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Wit Gele Kruis Limburg, Genk, Belgium
name: Brenda Aendekerk, MSc
role: STUDY_DIRECTOR
affiliation: Hasselt University
name: Valerie Storms, dr.
role: STUDY_DIRECTOR
affiliation: Hasselt University
name: Lars Grieten, dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Christophe Smeets, MSc
role: STUDY_CHAIR
References: