Portiuncula University Hospital
Ballinasloe, Galway, H53 T971, Ireland
Location status: Recruiting
Location contact
David Tiernan, MD
CONTACT
Derek O'Keeffe, MD, PhD
PRINCIPAL_INVESTIGATOR
Nuria Farre, MD, PhD
CONTACT
NCT Number: NCT06620653
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 call/virtual 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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Ballinasloe, Galway, H53 T971, Ireland
Location status: Recruiting
David Tiernan, MD
CONTACT
Derek O'Keeffe, MD, PhD
PRINCIPAL_INVESTIGATOR
Nuria Farre, MD, PhD
CONTACT
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 ClinicalTrials.gov. 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:
The lack of information technology (IT) literacy will not be an exclusion criterion.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients assigned to the intervention group will receive a tablet (if the patients do not have a tablet, computer or smartphone), a weight scale and a blood pressure monitor. The patients will provide daily biometric data (weight, heart rate and blood pressure) and report symptoms through four questions to capture worsening symptoms of the cardiac condition.
patients with a recent admission for heart failureare seen in a first face-to-face appointment within two weeks of discharge as per current 2021 ESC Heart Failure Guidelines with face-to-face follow up at 6 and 12 weeks.
Time frame: three months
Whether a follow-up with virtual wards reduces HF hospitalisation at three whether a follow up with virtual wards reduces HF hospitalisation at three months follow-up
Time frame: 12 months
Whether HF virtual wards reduces all cause mortality
Time frame: 3 months
Analysis of the financial implications of using the virtual heart failure ward in comparison to the cost of standard heart failure care
Contact information is provided by the study sponsor or research team.
David Tiernan, MD
CONTACT
Nuria Farre, MD, PhD
CONTACT
National University of Ireland, Galway, Ireland
Other
Acronym: HF-VW
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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