NCT06620653 Heart Failure Virtual Ward Research Study
| NCT ID | NCT06620653 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National University of Ireland, Galway, Ireland |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 346 participants |
| Start Date | 2024-10-18 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 346 participants in total. It began in 2024-10-18 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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.
Contact & Investigator
Derek O'Keeffe, MD, PhD
PRINCIPAL INVESTIGATOR
Galway University Hospitals/University of Galway
Frequently Asked Questions
Who can join the NCT06620653 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06620653 currently recruiting?
Yes, NCT06620653 is actively recruiting participants. Contact the research team at david.tiernan@universityofgalway.ie for enrollment information.
Where is the NCT06620653 trial being conducted?
This trial is being conducted at Ballinasloe, Ireland.
Who is sponsoring the NCT06620653 clinical trial?
NCT06620653 is sponsored by National University of Ireland, Galway, Ireland. The principal investigator is Derek O'Keeffe, MD, PhD at Galway University Hospitals/University of Galway. The trial plans to enroll 346 participants.
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