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Early Discharge to Clinic-Based Therapy of Patients Presenting with Heart Failure (EDICT-HF Trial)

Early Discharge to Clinic-Based Therapy of Patients Presenting with Decompensated Heart Failure: A Multi-Centre Randomised Controlled Trial Assessing Impact on Hospital Readmission Rates (EDICT-HF Trial)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000002583
Acronym
EDICT-HF
Enrollment
0
Registered
2024-01-08
Start date
2024-02-05
Completion date
Unknown
Last updated
2024-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Acute heart failure is an important condition involving a high rate of death and complications. Currently, patients with this condition are admitted to hospital and follow a common management strategy. This study aims to determine whether it is safe and effective to discharge patients presenting to the hospital with acute heart failure to an out-of-hospital clinic-based management strategy instead of having to be admitted to hospital. Evidence suggests that with each admission, patients often lose part of their function and are at a high risk for the negative effects associated with being in hospital. This study therefore may support the use of similar discharge management strategies for future patients and improve their quality of life, risk of hospital-acquired complications, hospital costs and help to preserve their physical function. Study participants will either discharge to this out-of-hospital pathway or be admitted under usual care, and results between the two groups will be compared. Participants will be medically managed under these two pathways until they are fit enough to be discharged home as if they were admitted to hospital. Both groups will have daily reviews by clinical staff to ensure their safety.

Interventions

The intervention involves patients presenting to the emergency department or admitted for less than 48 hours with ADHF (acute decompensated heart failure) receiving active management in the out-of-hospital setting. The intervention commences for each participant once they are discharged either directly from the emergency department or within 48 hours of inpatient admission. This will involve a hybrid care model, involving three times weekly reviews in a cardiologist-run clinic alongside daily ho

The intervention involves patients presenting to the emergency department or admitted for less than 48 hours with ADHF (acute decompensated heart failure) receiving active management in the out-of-hospital setting. The intervention commences for each participant once they are discharged either directly from the emergency department or within 48 hours of inpatient admission. This will involve a hybrid care model, involving three times weekly reviews in a cardiologist-run clinic alongside daily home reviews by Hospital in the Home (HITH) medical and nursing staff until cleared for discharge from active management. Cardiology clinic reviews will be 30-minute one-on-one face-to-face consults (with a cardiologist/other medical staff plus case discussion with a cardiologist) at Sunshine Hospital. Home reviews will involve 30-minute reviews at least daily, or more frequently as directed by the HITH team, face-to-face at the participant's home. The cardiology clinic reviews will involve implementing appropriate investigation and management according as directed by the treating cardiologist for their ADHF. ADHF management typically involves titrating oral or intravenous diuresis, introducing or titrating medications for heart failure mortality benefit, investigating/addressing the underlying cause of decompensation, correcting iron deficiency anaemia, and monitoring daily weights and haemodynamics. The priority of HITH reviews will be to monitor haemodynamics, daily weights and fluid balance, and titrate/administer required medications. This adherence to the intervention will be assessed by attendance of HITH daily home reviews and attendance at clinic reviews. The overall duration of the intervention involving this hybrid care model is expected to run over two years.

Sponsors

Dr Ben Costello
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Adult patients (>18 years) presenting to Sunshine Hospital / Footscray Hospital emergency department with ADHF • Patients admitted to an inpatient ward at Sunshine Hospital / Footscray Hospital with ADHF for <48hrs • Presentation of ADHF will be determined according to clinical presence of at least 1 relevant symptom and sign: o Symptoms: Dyspnoea, orthopnoea, oedema o Signs: Rales, peripheral oedema, ascites, pulmonary vascular congestion on chest radiography • Raised B-Type Natriuretic Peptide (BNP) (>30 pmol/L) • Informed consent is able to be received from participant

Exclusion criteria

• Haemodynamic instability: Systolic blood pressure <90mmHg or >180mmHg or Heart Rate >100 bpm or <60bpm • Raised oxygen requirements: Oxygen saturation < 93% on Room Air or Respiratory rate >24 breaths/min • Serum creatinine >250 umol/L +/- estimated glomerular filtration rate <30 ml/min/1.73m2 • Elevated Serum C-Reactive Protein (CRP) >50 mg/L • Intravenous vasodilatory or ionotropic agent requirement (excluding Digoxin) • Febrile >38 degrees Celsius or clinical suspicion of infection • Evidence of consolidation on chest radiography • Inpatient admission >48hrs • Meeting Fourth Universal Definition of Myocardial Infarction criteria • Unstable arrhythmia (ventricular or supraventricular arrhythmia associated with haemodynamic instability or symptoms) • Unsafe home discharge environment • Social or language barriers limiting capacity to gain informed consent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026