One Heart to Care for

Heart Failure Clinical Trial

— 1H2C4  

Official title:

One Heart to Care for, Your Heart to Take Care of.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04753398
• Other study ID #: 13/085U
• Status: Withdrawn
• Phase: N/A
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: February 2021
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk

Sponsors (3)

Lead Sponsor	Collaborator
Hasselt University	WGK Limburg, Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Medication titration	Mean doses ACE-I/angiotensin receptor blockers (ARB) en BB after 6 months	up to one year
Secondary	All-cause mortality	All-cause mortality	Up to one year
Secondary	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
Secondary	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
Secondary	Number of medical practitioner-patient contacts	In hospital (medical record); At patient home (WGK)	Up to one year
Secondary	Number of (telephone) contacts, registered by the heart failure nurse	Number of (telephone) contacts, registered by the heart failure nurse	Up to one year
Secondary	Number of (telephone) contacts for the encouragement of medication compliance	Number of (telephone) contacts for the encouragement of medication compliance	Up to one year
Secondary	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
Secondary	Quality of life according to the HeartQoL questionnaire		day 1, month 12
Secondary	Satisfaction survey	Satisfaction survey about the received care (anonymous)	month 12