Telemedically Assisted Optimization for Heart Failure Patients Before Cardiac Surgery to Improve Perioperative Outcome

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University Innsbruck

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • PREPARE-HF disease management program, which includes:

    Other intervention

    1. 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

162 Participants
are divided into 2 treatment groups
Group A: Control arm - Standard of care treatmentNo intervention 0 interventions
Group B: PREPARE-HFExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Hierachical Endpoint Perioperative Outcome: 30-day mortality

All-cause mortality from randomization to 30 days post-surgery

Time frame
assessed from randomization through 30 days post-surgery,
2

Hierachical Endpoint Perioperative Outcome: ECMO

Requirement for extracorporeal membrane oxygenation (ECMO) within 30 days post-surgery

Time frame
assessed from surgery until 30 days post-surgery
3

Hierachical Endpoint Perioperative Outcome: hemodialysis or ultrafiltration

Need for hemodialysis or ultrafiltration within 30 days post-surgery

Time frame
assessed from surgery until 30 days post-surgery
4

Hierachical Endpoint Perioperative Outcome: stay on ICU

Length of stay in the intensive care unit (ICU) within 30 days post-surgery

Time frame
assessed from surgery until 30 days post-surgery.

Secondary outcomes

1

Preoperative adverse events: death

Death prior to surgery

Time frame
will be assessed on day prior to surgery
2

Preoperative adverse events: hospitalization

Cardiovascular related hospitalization prior to surgery

Time frame
will be assessed on day prior to surgery
3

Preoperative adverse events: urgent surgery necessary

Urgent cardiac surgery necessary before scheduled surgery date

Time frame
will be assessed on day prior to surgery
4

Perioperative outcome: 30-day mortality

30-day mortality after surgery

Time frame
will be assessed on day 30 after surgery

Other outcomes

1

Safety endpoint: Hyperkalemia

Hyperkalemia (\>6mmol/l) will be assessed as a safety endpoint throughout the PREPARE-HF program.

Time frame
from randomization to day prior to surgery
2

Safety endpoint: Acute kidney injury

Acute kidney injury (\>= AKIN 2) will be assessed as a safety endpoint throughout the PREPARE-HF program.

Time frame
from randomization to day prior to surgery
3

Safety endpoint: Syncope

Syncope due to hypotension or bradycardia will be assessed as a safety endpoint throughout the PREPARE-HF program.

Time frame
from randomization to day prior to surgery
4

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.

Time frame
from randomization to day prior to surgery

Sponsors and contacts

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