One Heart to Care for

NCT04753398 | Withdrawn

• 1 other identifier: 13/085U
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart Failure; Telemonitoring; medication up titration; automatic blood pressure device; medication dispenser

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  week 24

Secondary Outcomes (10)

• Medication titration

  up to one year

• All-cause mortality

  Up to one year

• All cardio-related hospitalisations (number and time)

  Up to one year

• All heart failure hospitalisations

  Up to one year

• Number of medical practitioner-patient contacts

  Up to one year

Study Arms (2)

Telemonitoring group

EXPERIMENTAL

Additional telemonitoring devices: Blood Pressure Monitor, medication dispenser, telemonitoring technology

Device: Blood Pressure Monitor, medication dispenser, telemonitoring technology

Control group

NO INTERVENTION

usual care, without telemonitoring

Interventions

Blood Pressure Monitor, medication dispenser, telemonitoring technology DEVICE

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

Also known as: Telemedicine, remote monitoring, remote follow-up

Telemonitoring group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasselt University: lead
• Ziekenhuis Oost-Limburg: collaborator
• WGK Limburg: collaborator

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Blood Pressure Monitors

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sphygmomanometers; Diagnostic Equipment; Equipment and Supplies

Study Officials

• Pieter Vandervoort, prof. dr.

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

• Brenda Aendekerk, MSc

  Wit Gele Kruis Limburg, Genk, Belgium

  STUDY DIRECTOR

• Valerie Storms, dr.

  Hasselt University

  STUDY DIRECTOR

• Lars Grieten, dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

• Christophe Smeets, MSc

  Hasselt University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: March 3, 2014
• First Posted: February 15, 2021
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: February 15, 2021

Record last verified: 2021-02

Locations

BE (1)