One Heart to Care for (1H2C4)

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• Status: Withdrawn
• Conditions: Heart Failure
• Intervention / Treatment: Device: Blood Pressure Monitor, medication dispenser, telemonitoring technology

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication titration	Mean doses ACE-I/angiotensin receptor blockers (ARB) en BB after 6 months	up to one year
All-cause mortality	All-cause mortality	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,…)	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	Up to one year
Number of medical practitioner-patient contacts	In hospital (medical record); At patient home (WGK)	Up to one year
Number of (telephone) contacts, registered by the heart failure nurse	Number of (telephone) contacts, registered by the heart failure nurse	Up to one year
Number of (telephone) contacts for the encouragement of medication compliance	Number of (telephone) contacts for the encouragement of medication compliance	Up to one year
Evolution of heart failure and comorbidities	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		day 1, month 12
Satisfaction survey	Satisfaction survey about the received care (anonymous)	month 12

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Ziekenhuis Oost-Limburg; WGK Limburg
• Investigators: 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

Study Major Dates

• Study Start (ACTUAL): January 1, 2014
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: March 3, 2014
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (ACTUAL): February 15, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 15, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Heart Failure; Telemonitoring; medication up titration; automatic blood pressure device; medication dispenser
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 13/085U