Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620653
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Heart Failure Virtual Ward Research Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Heart Failure Virtual Ward Research Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HF-VW
Brief Summary:
The main aim will be to evaluate whether a follow-up with virtual wards reduces HF hospitalisation at three months follow-up Hospital admission will be defined as any hospital admission or an emergency room stay of more than 24 h requiring IV diuretics
The secondary objectives will be to evaluate whether this intervention reduces all-cause mortality all-cause hospitalisation at three months is cost-effectiveness is associated with a higher percentage of prescription and dose of prognostic medication and improves the quality of life To assess the potential long-term effects of the virtual wards follow-up we will evaluate whether this intervention reduces all-cause mortality and HF hospitalisation at 6- and 12-months by a telephone callvirtual outpatients appointment
The study outcomes will be ascertained at each visit Given the study design it is impossible to assess the endpoints in a blinded manner Clinical events during the study will be adjudicated by an operational committee whose members will be unaware of the group assignment
The secondary objectives will be to evaluate whether this intervention reduces all-cause mortality all-cause hospitalisation at three months is cost-effectiveness is associated with a higher percentage of prescription and dose of prognostic medication and improves the quality of life To assess the potential long-term effects of the virtual wards follow-up we will evaluate whether this intervention reduces all-cause mortality and HF hospitalisation at 6- and 12-months by a telephone callvirtual outpatients appointment
The study outcomes will be ascertained at each visit Given the study design it is impossible to assess the endpoints in a blinded manner Clinical events during the study will be adjudicated by an operational committee whose members will be unaware of the group assignment
Detailed Description:
This is a randomized controlled multicentre parallel-group trial in which we will consecutively include all patients over 18 years of age with a recent hospitalisation due to decompensated HF and randomise them to usual care vs telemedicine follow-up Any stay in the emergency department or ward for over 24 hours that required treatment with intravenous diuretic will be considered an hospitalisation
The heart failure diagnosis will be made according to the 2021 ESC Heart Failure Guidelines
The study will be registered at ClinicalTrialsgov The study will be guided by good clinical practice GCP in accordance with the Declaration of Helsinki and the laws and regulations applicable in Ireland Written approval from the appropriate Ethics Committees will be required and each patient will provide written informed consent before enrolling in the study
Patients will be recruited from the participant hospitals Portiuncula University Hospital and Galway University Hospital
Inclusion criteria The study will include adult patients 18 years with a recent hospitalisation We will include all ranges of ejection fraction and also patients with known and de novo heart failure
The main exclusion criteria will be
Patients who decline to participate in the study
Patient in palliative care or with a life expectancy of less than one year
Patients referred to skilled nursing facilities or nursing homes at hospital discharge
Patients with planned intervention on the mitral or aortic valve during admission or scheduled early after discharge
Planned haemodialysis
Patients included in other randomized controlled trials
Patients who at the investigators discretion are considered unable to participate in the study mainly due to a previous history of non-compliance with medication and follow-up appointments language barrier or moderate or severe cognitive impairment without the support of a family membercaregiver
Patients with asymptomatic NYHA class I left ventricular dysfunction usually in the setting of an acute myocardial infarction
The lack of information technology IT literacy will not be an exclusion criterion
The heart failure diagnosis will be made according to the 2021 ESC Heart Failure Guidelines
The study will be registered at ClinicalTrialsgov The study will be guided by good clinical practice GCP in accordance with the Declaration of Helsinki and the laws and regulations applicable in Ireland Written approval from the appropriate Ethics Committees will be required and each patient will provide written informed consent before enrolling in the study
Patients will be recruited from the participant hospitals Portiuncula University Hospital and Galway University Hospital
Inclusion criteria The study will include adult patients 18 years with a recent hospitalisation We will include all ranges of ejection fraction and also patients with known and de novo heart failure
The main exclusion criteria will be
Patients who decline to participate in the study
Patient in palliative care or with a life expectancy of less than one year
Patients referred to skilled nursing facilities or nursing homes at hospital discharge
Patients with planned intervention on the mitral or aortic valve during admission or scheduled early after discharge
Planned haemodialysis
Patients included in other randomized controlled trials
Patients who at the investigators discretion are considered unable to participate in the study mainly due to a previous history of non-compliance with medication and follow-up appointments language barrier or moderate or severe cognitive impairment without the support of a family membercaregiver
Patients with asymptomatic NYHA class I left ventricular dysfunction usually in the setting of an acute myocardial infarction
The lack of information technology IT literacy will not be an exclusion criterion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None