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One Heart to Care for (1H2C4)

H

Hasselt University

Status

Withdrawn

Conditions

Heart Failure

Treatments

Device: Blood Pressure Monitor, medication dispenser, telemonitoring technology

Study type

Interventional

Funder types

Other

Identifiers

NCT04753398
13/085U

Details and patient eligibility

About

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.

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups

Telemonitoring group
Experimental group
Description:
Additional telemonitoring devices: Blood Pressure Monitor, medication dispenser, telemonitoring technology
Treatment:
Device: Blood Pressure Monitor, medication dispenser, telemonitoring technology
Control group
No Intervention group
Description:
usual care, without telemonitoring

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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