Heart FailureHF-VWNCT06620653
Heart Failure Virtual Ward Research Study
A study testing Telemonitoring in people with Heart Failure, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Telemonitoring
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 1 siteIreland
- Study dates
- 18 Oct 2024to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
Portiuncula University Hospital
Ballinasloe, Galway, H53 T971
Nuria Farre, MD, PhD, +353090 964 8200, nuria.farre@hse.ie
David Tiernan, MD, +353861735800, david.tiernan@universityofgalway.ie
About this 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.
Read the 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 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.
- Conditions
- Heart Failure
- Being tested
- Telemonitoring, Standard Care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemonitoringOther
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Active comparator | All patients with a recent admission for decompensated heart failure are seen in a first face-to-face appointment within two weeks of discharge as per current 2021 ESC Heart Failure Guidelines.
The standard care group will receive the usual nurse lead structured follow up and patients in the usual care will have a face-to-face appointment at week 6 and 12, and all the other contacts will be phone calls or face-to-face Receives: Other: Standard Care |
| Telemonitoring | Experimental | After the initial face-to-face appointment the telemonitoring group will have appointments at week 4 (phone call or videoconference), week 6 (videoconference), week 8 (phone call or videoconference) and week 12 (videoconference). In total, the patients will have 6 structured appointments.
Extra phone calls, videoconferences, and face-to-face visits will be made at any time, depending on the patient's needs, irrespective of the assigned group.
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.
The system will generate warning alarms (biometrics out of range or symptom reporting) and alerts (information related to the function of the household devices). Receives: Other: Telemonitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in re-admission rates
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
Measured: three months
Secondary outcomes (2)
All cause mortality
Whether HF virtual wards reduces all cause mortality
Measured: 12 months
Financial Cost of virtual ward in comparison to the standard care
Analysis of the financial implications of using the virtual heart failure ward in comparison to the cost of standard heart failure care
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start18 Oct 2024
- Primary completionFeb 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial. half of the participants will be in the tele monitoring group while the other half will be in the current standard of care group
- Masking
- None (open label)
- Enrolment
- 346 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Ireland, Galway, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Health Service Executive, Ireland
- Responsible party
- Principal investigator, Derek O'Keeffe, National University of Ireland, Galway, Ireland
- Investigators
- Derek O'Keeffe, MD, PhD, Principal investigator, Galway University Hospitals/University of Galway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620653
- Sponsor's protocol ID
- Heart Failure Virtual Ward
- Acronym
- HF-VW
- Status last verified
- Apr 2026
- First submitted
- 23 Jul 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miller-Davis C, Marden S, Leidy NK. The New York Heart Association Classes and functional status: what are we really measuring? Heart Lung. 2006 Jul-Aug;35(4):217-24. doi: 10.1016/j.hrtlng.2006.01.003.
PubMed 16863893
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure Virtual Ward Research Study
- ClinicalTrials.gov ID
- NCT06620653
- Acronym / sponsor ID
- HF-VW / Heart Failure Virtual Ward
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 346 participants (estimated)
- Lead sponsor
- National University of Ireland, Galway, IrelandUniversity, hospital or other
- Collaborators
- Health Service Executive, Ireland
- Study start
- 18 Oct 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled trial. half of the participants will be in the tele monitoring group while the other half will be in the current standard of care group
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Other: Standard CareAll patients with a recent admission for decompensated heart failure are seen in a first face-to-face appointment within two weeks of discharge as per current 2021 ESC Heart Failure Guidelines. The standard care group will receive the usual nurse lead structured follow up and patients in the usual care will have a face-to-face appointment at week 6 and 12, and all the other contacts will be phone calls or face-to-face |
| Telemonitoring | Experimental | Other: TelemonitoringAfter the initial face-to-face appointment the telemonitoring group will have appointments at week 4 (phone call or videoconference), week 6 (videoconference), week 8 (phone call or videoconference) and week 12 (videoconference). In total, the patients will have 6 structured appointments. Extra phone calls, videoconferences, and face-to-face visits will be made at any time, depending on the patient's needs, irrespective of the assigned group. 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. The system will generate warning alarms (biometrics out of range or symptom reporting) and alerts (information related to the function of the household devices). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemonitoringPatients 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. | Other | Telemonitoring |
| Standard Carepatients 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. | Other | Standard Care |
Primary outcome
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
2 secondary outcomes
All cause mortality
Time frame: 12 months
Financial Cost of virtual ward in comparison to the standard care
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Background: PubMed 16863893Miller-Davis C, Marden S, Leidy NK. The New York Heart Association Classes and functional status: what are we really measuring? Heart Lung. 2006 Jul-Aug;35(4):217-24. doi: 10.1016/j.hrtlng.2006.01.003.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Derek O'Keeffe, MD, PhD principal investigator
Galway University Hospitals/University of Galway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring in people with Heart Failure, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Tiernan, MD (+353 861735800, david.tiernan@universityofgalway.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in re-admission rates (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06620653, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.