One Heart to Care for

Hasselt University

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Conditions

Heart Failure

Interventions

Blood Pressure Monitor, medication dispenser, telemonitoring technologyDEVICE

The telemonitoring interference in the telemonitoring arm consists of an automatic blood pressure device and medication dispenser that transmit data to a central platform.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Ziekenhuis Oost-Limburg

Genk, Belgium

Outcomes

Primary Outcomes

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.

Time frame: week 12

Mean medication doses

Time frame: week 24

Secondary Outcomes

Medication titration

Mean doses ACE-I/angiotensin receptor blockers (ARB) en BB after 6 months

Time frame: up to one year

All-cause mortality

Time frame: 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,…)

Time frame: 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

Time frame: Up to one year

Number of medical practitioner-patient contacts

* In hospital (medical record) * At patient home (WGK)

Time frame: Up to one year

Data from ClinicalTrials.gov

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