One Heart to Care for - Clinical Trial for Heart Failure | NCT04753398

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Primary Purpose

Status

Withdrawn

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Blood Pressure Monitor, medication dispenser, telemonitoring technology

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring Heart Failure, Telemonitoring, medication up titration, automatic blood pressure device, medication dispenser

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Ziekenhuis Oost-Limburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telemonitoring group

Control group

Arm Description

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

usual care, without telemonitoring

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

Medication titration

Mean doses ACE-I/angiotensin receptor blockers (ARB) en BB after 6 months

All-cause mortality

All cardio-related hospitalisations (number and time)

Arrythmogenic nature Ischemic nature Heart failure nature Valvular/surgical nature Elektrofysiological nature (implantation ICD, CRT,…)

All heart failure hospitalisations

Treatment with (whether or not intravenous) diuretic therapy Treatment with hemodynamic guided therapy (vasodilators) Treatment with intravenous inotropics

Number of medical practitioner-patient contacts

In hospital (medical record) At patient home (WGK)

Number of (telephone) contacts, registered by the heart failure nurse

Number of (telephone) contacts for the encouragement of medication compliance

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

Quality of life according to the HeartQoL questionnaire

Satisfaction survey

Satisfaction survey about the received care (anonymous)

Full Information

NCT ID

NCT04753398

First Posted

March 3, 2014

Last Updated

February 10, 2021

Sponsor

Hasselt University

Collaborators

Ziekenhuis Oost-Limburg, WGK Limburg

1. Study Identification

Unique Protocol Identification Number

NCT04753398

Brief Title

One Heart to Care for

Acronym

1H2C4

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Withdrawn

Why Stopped

No patients included

Study Start Date

January 2014 (Actual)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hasselt University

Collaborators

Ziekenhuis Oost-Limburg, WGK Limburg

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Telemonitoring group

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

No Intervention

Arm Description

usual care, without telemonitoring

Intervention Type

Device

Intervention Name(s)

Blood Pressure Monitor, medication dispenser, telemonitoring technology

Other Intervention Name(s)

Telemedicine, remote monitoring, remote follow-up

Intervention Description

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

Primary Outcome Measure Information:

Title

Mean medication doses

Description

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.

Time Frame

week 12

Title

Mean medication doses

Description

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

Time Frame

week 24

Secondary Outcome Measure Information:

Title

Medication titration

Description

Mean doses ACE-I/angiotensin receptor blockers (ARB) en BB after 6 months

Time Frame

up to one year

Title

All-cause mortality

Description

All-cause mortality

Time Frame

Up to one year

Title

All cardio-related hospitalisations (number and time)

Description

Arrythmogenic nature Ischemic nature Heart failure nature Valvular/surgical nature Elektrofysiological nature (implantation ICD, CRT,…)

Time Frame

Up to one year

Title

All heart failure hospitalisations

Description

Treatment with (whether or not intravenous) diuretic therapy Treatment with hemodynamic guided therapy (vasodilators) Treatment with intravenous inotropics

Time Frame

Up to one year

Title

Number of medical practitioner-patient contacts

Description

In hospital (medical record) At patient home (WGK)

Time Frame

Up to one year

Title

Number of (telephone) contacts, registered by the heart failure nurse

Description

Number of (telephone) contacts, registered by the heart failure nurse

Time Frame

Up to one year

Title

Number of (telephone) contacts for the encouragement of medication compliance

Description

Number of (telephone) contacts for the encouragement of medication compliance

Time Frame

Up to one year

Title

Evolution of heart failure and comorbidities

Description

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

Time Frame

up to one year

Title

Quality of life according to the HeartQoL questionnaire

Time Frame

day 1, month 12

Title

Satisfaction survey

Description

Satisfaction survey about the received care (anonymous)

Time Frame

month 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials: