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NCT Number: NCT06620653

Heart Failure Virtual Ward Research Study

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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:

  • 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 investigator's 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 member/caregiver.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (≥ 18 years) with a recent hospitalisation.
  • Known ejection fraction and NYHA Class
  • Known or de novo Heart Failure
  • Patient or carer able to speak and understand English/Irish
  • Willing to participate in the study.
  • Within catchment area of the Saolta group.

Exclusion criteria

  • 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 investigator's 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 member/caregiver.
  • 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.

Treatment and study plan

Telemonitoring

Other

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.

Standard care

Other

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.

Primary outcomes

  1. Reduction in re-admission rates

    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

Secondary outcomes

  1. All cause mortality

    Time frame: 12 months

    Whether HF virtual wards reduces all cause mortality

  2. Financial Cost of virtual ward in comparison to the standard care

    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

Study contacts

Contact information is provided by the study sponsor or research team.

David Tiernan, MD

CONTACT

[email protected]

+353 861735800

Nuria Farre, MD, PhD

CONTACT

[email protected]

+35390 964 8200

Sponsors and collaborators

Lead sponsor

National University of Ireland, Galway, Ireland

Other

Collaborators

  • Health Service Executive, Ireland

Registry information

Acronym: HF-VW

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 1, 2024
Registry last updated
Apr 15, 2026

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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