About this trial
Patients with heart failure undergoing cardiac surgery face a significantly increased perioperative risk, yet no standardized strategy exists to mitigate this risk effectively. Current preoperative management relies on optimization of medical therapy without a structured prehabilitation approach. Given the strong association between eleveated preoperative N-terminal pro-B-type natriuretic peptide levels and postoperative outcomes, patients at increased risk could be identified using this biomarker. Telemedical disease management programs have demonstrated efficacy in outpatient heart failure care, but their role in preoperative optimization remains underexplored. This study aims to assess whether a structured, multidisciplinary, telemedicine-assisted prehabilitation program can reduce perioperative complications, and improve surgical outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Indication for elective cardiac surgery in the Heart team
NTproBNP ≥ 1500 ng/L
≥ 18 years willing to participate in trial
Written informed consent
Disqualifiers
Neuropsychiatric disorders / illnesses (e.g. drug addiction, alcohol abuse) that do not allow adherent participation in the study
No sufficient ability to measure and transfer data or existing support in the social environment
no sufficient ability to communicate (language skills, eyesight, hearing)
Pregnancy
Trial design
Parallel
Treatments tested in this trial
PREPARE-HF disease management program, which includes:
Other intervention1. Heart failure education and training 2. Optimization of guideline-directed medical therapy (GDMT) 3. Telemedical / telenursing / monitoring and therapy adjustments 4. Supervised telemedicine-assisted exercise program
Treatment groups
Trial outcomes
Primary outcomes
Hierachical Endpoint Perioperative Outcome: 30-day mortality
All-cause mortality from randomization to 30 days post-surgery
Hierachical Endpoint Perioperative Outcome: ECMO
Requirement for extracorporeal membrane oxygenation (ECMO) within 30 days post-surgery
Hierachical Endpoint Perioperative Outcome: hemodialysis or ultrafiltration
Need for hemodialysis or ultrafiltration within 30 days post-surgery
Hierachical Endpoint Perioperative Outcome: stay on ICU
Length of stay in the intensive care unit (ICU) within 30 days post-surgery
Secondary outcomes
Preoperative adverse events: death
Death prior to surgery
Preoperative adverse events: hospitalization
Cardiovascular related hospitalization prior to surgery
Preoperative adverse events: urgent surgery necessary
Urgent cardiac surgery necessary before scheduled surgery date
Perioperative outcome: 30-day mortality
30-day mortality after surgery
Other outcomes
Safety endpoint: Hyperkalemia
Hyperkalemia (\>6mmol/l) will be assessed as a safety endpoint throughout the PREPARE-HF program.
Safety endpoint: Acute kidney injury
Acute kidney injury (\>= AKIN 2) will be assessed as a safety endpoint throughout the PREPARE-HF program.
Safety endpoint: Syncope
Syncope due to hypotension or bradycardia will be assessed as a safety endpoint throughout the PREPARE-HF program.
Safety endpoint: hospitalization
Unplanned hospitalization not due to heart failure or cardiac surgery will be assessed as a safety endpoint throughout the PREPARE-HF program.
Sponsors and contacts
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