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

NCT07391683 | Recruiting

• 1 other identifier: 1169/2025
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patients With Heart Failure Undergoing Cardiac Surgery

Keywords

cardiac surgery; heart failure; Telemedically Assisted optimization program; prehab; Cardiac Surgical Procedures; Perioperative Care; Preoperative Exercise; Remote Patient Monitoring; Telemedicine

Outcome Measures

Primary Outcomes (4)

• Hierachical Endpoint Perioperative Outcome: 30-day mortality

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

  assessed from randomization through 30 days post-surgery,

• Hierachical Endpoint Perioperative Outcome: ECMO

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

  assessed from surgery until 30 days post-surgery

• Hierachical Endpoint Perioperative Outcome: hemodialysis or ultrafiltration

  Need for hemodialysis or ultrafiltration within 30 days post-surgery

  assessed from surgery until 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

  assessed from surgery until 30 days post-surgery.

Secondary Outcomes (22)

• Preoperative adverse events: death

  will be assessed on day prior to surgery

• Preoperative adverse events: hospitalization

  will be assessed on day prior to surgery

• Preoperative adverse events: urgent surgery necessary

  will be assessed on day prior to surgery

• Perioperative outcome: 30-day mortality

  will be assessed on day 30 after surgery

• Perioperative outcome: ECMO

  will be assessed on day 30 after surgery

Other Outcomes (6)

• Safety endpoint: Hyperkalemia

  from randomization to day prior to surgery

• Safety endpoint: Acute kidney injury

  from randomization to day prior to surgery

• Safety endpoint: Syncope

  from randomization to day prior to surgery

Study Arms (2)

Control arm - Standard of care treatment

NO INTERVENTION

Receives standard preoperative care until surgery.

PREPARE-HF

EXPERIMENTAL

Preoperative Heart Failure Optimization and Telemedicine Integration

Other: PREPARE-HF disease management program, which includes:

Interventions

PREPARE-HF disease management program, which includes: OTHER

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

PREPARE-HF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication for elective cardiac surgery in the Heart team
• NTproBNP ≥ 1500 ng/L
• ≥ 18 years willing to participate in trial
• Written informed consent

You may not qualify if:

• 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
• Chronic kidney disease requiring dialysis
• Planed procedure: heart transplantation (HTX), implant of left ventricular mechanical assist devices (L-VAD)

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University of Innsbruck - Department of Cardiology & Department of Cardiac Surgery

Innsbruck, Tyrol, 6020, Austria

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Can Gollmann-Tepeköylü, Prof.

  Medical University of Innsbruck - Department of cardiac surgery

  PRINCIPAL INVESTIGATOR

• Gerhard Pölzl, Prof.

  Medical University of Innsbruck - Department of cardiology

  PRINCIPAL INVESTIGATOR

• Christian Puelacher, MD

  Medical University of Innsbruck - Department of cardiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Can Gollmann-Tepeköylü, Prof.

CONTACT

+4351250480466; can.gt@i-med.ac.at

Leo Winter-Pölzl, MD

CONTACT

+4351250484591; leo.poelzl@i-med.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding is not feasible because the intervention involves overt telemedical monitoring, patient education, and individualized therapeutic adjustments that are readily apparent to both patients and healthcare providers, necessitating an open-label study design.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: February 6, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): April 16, 2029
• Study Completion (Estimated): January 1, 2034
• Last Updated: February 18, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: following publication of primary and secondary results
• Access Criteria: Data will be shared upon reasonable request.

Locations

AU (1)