One Heart to Care for

Not Applicable

Withdrawn

• Conditions: Heart Failure

• Registration Number: NCT04753398
• Lead Sponsor: Hasselt University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-03-03
• Primary Completion: 2015-12
• Study Completion: 2016-12
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-10
• Last Update Submitted: 2021-02-10
• Study First Posted: 2021-02-15
• Last Update Posted: 2021-02-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean medication doses	week 24	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

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	Up to one year	All-cause mortality
Medication titration	up to one year	Mean doses ACE-I/angiotensin receptor blockers (ARB) en BB after 6 months
All cardio-related hospitalisations (number and time)	Up to one year	* Arrythmogenic nature; * Ischemic nature; * Heart failure nature; * Valvular/surgical nature; * Elektrofysiological nature (implantation ICD, CRT,...)
All heart failure hospitalisations	Up to one year	* Treatment with (whether or not intravenous) diuretic therapy; * Treatment with hemodynamic guided therapy (vasodilators); * Treatment with intravenous inotropics
Number of (telephone) contacts for the encouragement of medication compliance	Up to one year	Number of (telephone) contacts for the encouragement of medication compliance
Number of (telephone) contacts, registered by the heart failure nurse	Up to one year	Number of (telephone) contacts, registered by the heart failure nurse
Satisfaction survey	month 12	Satisfaction survey about the received care (anonymous)
Number of medical practitioner-patient contacts	Up to one year	* In hospital (medical record); * At patient home (WGK)
Evolution of heart failure and comorbidities	up to one year	* 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
Quality of life according to the HeartQoL questionnaire	day 1, month 12

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium