Telemedically Assisted Optimization for Heart Failure Patients Before Cardiac Surgery to Improve Perioperative Outcome (PREPARE-HF)

Prospective, Randomized Open Label Trial of Telemedically Assisted Optimization for Heart Failure Patients Before Cardiac Surgery to Improve Perioperative Outcome

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.

Study Overview

• Status: Recruiting
• Conditions: Patients With Heart Failure Undergoing Cardiac Surgery
• Intervention / Treatment: Other: PREPARE-HF disease management program, which includes:

Detailed Description

Patients with heart failure undergoing elective cardiac surgery represent a particularly vulnerable population with a substantially increased risk of perioperative morbidity and mortality. Despite advances in surgical techniques and perioperative care, adverse outcomes such as early postoperative mortality, need for extracorporeal membrane oxygenation (ECMO)need for temporary renal replacement therapy, , and prolonged intensive care unit (ICU) stay,remain frequent in this high-risk group. Current perioperative management largely relies on outpatient treating physicians to optimize guideline-directed medical therapy (GDMT) without a structured, standardized strategy for preoperative optimization or "prehabilitation" tailored to heart failure patients. A key issue for resource intensive optimization programs is the need for good patient selection to identify high-risk patients. N-terminal pro-B-type natriuretic peptide (NT-proBNP) is a well-established biomarker reflecting cardiac wall stress and neurohormonal activation. Elevated NT-proBNP levels are independently associated with adverse perioperative and long-term outcomes in patients undergoing both non-cardiac and cardiac surgery. Retrospective data from large surgical cohorts, including analyses from our center, have demonstrated that high preoperative NT-proBNP levels are linked to increased ICU length of stay, higher rates of renal replacement therapy and ECMO use, as well as increased short- and long-term mortality. Importantly, an improvement in measured NT-proBNP levels,reflecting improved heart failure status, were associated with significantly better perioperative outcomes, suggesting that NT-proBNP is not only a risk marker but also identifies potentially optimizable patients. Telemedical disease management programs have proven effective in outpatient heart failure care by improving adherence to GDMT, enabling early detection of clinical deterioration, and reducing hospitalizations. However, the application of such structured telemedicine-assisted interventions in the preoperative setting of cardiac surgery has not been systematically evaluated. The perioperative period offers a unique therapeutic window in which optimization of volume status, neurohormonal blockade, functional capacity, and patient education may translate into improved surgical readiness and outcomes. The PREPARE-HF project was designed to address this unmet clinical need by evaluating a multidisciplinary, telemedicine-assisted preoperative optimization program for high-risk heart failure patients scheduled for elective cardiac surgery. The intervention integrates structured heart failure education, optimization of guideline-directed medical therapy, continuous telemonitoring, supervised exercise training, and psychological support, with the aim of improving perioperative complications compared with standard of care. PREPARE-HF is conducted as a prospective, randomized, open-label ontrolled clinical trial in which 162 patients with elevated NT-proBNP levels (≥1500 ng/L) are randomized in a 1:1 ratio to either the intervention program or standard preoperative care, with stratification according to surgical procedure type. The primary endpoint is a hierarchical composite outcome assessed using the Finkelstein-Schoenfeld win ratio methodology, incorporating all-cause mortality, need for extracorporeal membrane oxygenation, requirement for renal replacement therapy, and length of intensive care unit stay within 30 days after surgery. Secondary endpoints include safety endpoints, preoperative events, perioperative complications, short- and long-term mortality, functional capacity, quality of life, biomarker dynamics, and adherence to guideline-directed heart failure therapy, enabling a comprehensive assessment of the intervention's impact on perioperative and long-term outcomes in this vulnerable patient population.

• Study Type: Interventional
• Enrollment (Estimated): 162
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Can Gollmann-Tepeköylü, Prof.; Phone Number: +4351250480466; Email: can.gt@i-med.ac.at
• Study Contact Backup: Name: Leo Winter-Pölzl, MD; Phone Number: +4351250484591; Email: leo.poelzl@i-med.ac.at

Study Locations

• Austria
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Recruiting
      • Medical University of Innsbruck - Department of Cardiology & Department of Cardiac Surgery
      • Contact: Can Gollmann-Tepeköylü, Prof.; Phone Number: +43 512 504 80466; Email: can.gt@i-med.ac.at
      • Contact: Leo Winter-Pölzl, MD; Phone Number: +43 512 504 84591; Email: leo.poelzl@i-med.ac.at
      • Principal Investigator: Can Gollmann-Tepeköylü, Prof.
      • Principal Investigator: Gerhard Pölzl, Prof.
      • Principal Investigator: Christian Puelacher, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control arm - Standard of care treatment; Receives standard preoperative care until surgery.
Experimental: PREPARE-HF; Preoperative Heart Failure Optimization and Telemedicine Integration	Other: PREPARE-HF disease management program, which includes: Heart failure education and training; Optimization of guideline-directed medical therapy (GDMT); Telemedical / telenursing / monitoring and therapy adjustments; Supervised telemedicine-assisted exercise program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative adverse events: death	Death prior to surgery	will be assessed on day prior to surgery
Preoperative adverse events: hospitalization	Cardiovascular related hospitalization prior to surgery	will be assessed on day prior to surgery
Preoperative adverse events: urgent surgery necessary	Urgent cardiac surgery necessary before scheduled surgery date	will be assessed on day prior to surgery
Perioperative outcome: 30-day mortality	30-day mortality after surgery	will be assessed on day 30 after surgery
Perioperative outcome: ECMO	Need for extracorporeal membrane oxygenation (ECMO) within 30 days post-surgery	will be assessed on day 30 after surgery
Perioperative outcome: hemodialysis or ultrafiltration	Need for hemodialysis or ultrafiltration within 30 days post- surgery	will be assessed on day 30 after surgery
Perioperative outcome: days on ICU	Duration of stay (days) on intensive care unit within 30 days post-surgery	will be assessed on day 30 after surgery
Preoperative risk assessment	Change in EuroSCORE II (estimated 30-day mortality, %) from randomization to the pre-operative day.	assessed at randomization and on day before surgery
Quality of guideline-directed heart failure medical therapy (GDMT)	It examines which recommended drug classes patients receive and whether these therapies are prescribed according to current clinical guidelines. In addition, the analysis measures the dosage of each medication and determines the extent to which the prescribed dose corresponds to the percentage of the target dose recommended by the guidelines.	assessed at randomization an on day prior to surgery
5-year mortality	5-year mortality after surgery	will be assessed within the 5-years after surgery
EQ-5D-5L	Difference in EQ-5D-5L index score (a standardized measure of health-related quality of life developed by the EuroQol Group; range -0.594 to 1.000, with higher scores indicating better health status, 1.000 representing full health, 0 equivalent to death, and negative values indicating health states perceived as worse than death) from baseline to each time point.	from randomization to postoperative visit at 5 years post-surgery
EHFScB	Difference in the European Heart Failure Self-care Behaviour Scale (EHFScB; a standardized measure of heart failure-related self-care behaviour; score range 0-100, with lower scores indicating better self-care behaviour and higher scores indicating poorer self-care) from baseline to each time point.	from randomization to postoperative visit at 5 years post-surgery
GAD-7	Difference in the Generalized Anxiety Disorder 7-item scale (GAD-7; a standardized measure of anxiety severity; score range 0-21, with higher scores indicating greater anxiety severity: 0-4 minimal, 5-9 mild, 10-14 moderate, and 15-21 severe anxiety) from baseline to each time point.	assessed at randomization and on day before surgery
6-minute walk test	Changes in 6-minute walk test from baseline to preoperative visit will be evaluated.	assessed at randomization and on day prior to surgery
1-minute sit to stand test	Changes in 1-minute sit to stand test from baseline to preoperative visit will be evaluated.	assessed at randomization and on day prior to surgery
NT-proBNP	Changes in NT-proBNP values from baseline to preoperative visit will be evaluated.	assessed at randomization and on day prior to surgery
Kidney function	Changes in creatinine levels and eGFR from baseline to preoperative visit will be evaluated.	assessed at randomization and on day prior to surgery
APACHE II Score	Difference in the Acute Physiology and Chronic Health Evaluation II score (APACHE II; a widely used severity-of-disease classification system for critically ill patients; score range 0-71, with higher scores indicating greater disease severity and higher predicted mortality) assessed daily throughout the intensive care unit stay.	daily from the day of surgery until 30 days after surgery, on each day the patient is in the intensive care unit
NYHA stage	Change in New York Heart Association (NYHA) functional class (a clinician-assessed measure of heart failure symptom severity; classes I-IV, with higher classes indicating greater functional limitation) from baseline to each time point.	from randomization to postoperative visit at 5 years post-surgery
red blood concentrates	The necessity for red blood cell concentrates during surgery and within the first 30 days after surgery will be evaluated.	assessed from surgery until 30 days post-surgery
Smoking status	Changes in number of smokers from baseline from each time point.	from randomization to postoperative visit at 5 years post-surgery
ECHO	Changes in echocardiographic parameters (LV-EF; TAPSE; Severity of valvular heart disease) from baseline to preoperative visit will be evaluated.	assessed at randomization and on day prior to surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety endpoint: Hyperkalemia	Hyperkalemia (>6mmol/l) will be assessed as a safety endpoint throughout the PREPARE-HF program.	from randomization to day prior to surgery
Safety endpoint: Acute kidney injury	Acute kidney injury (>= AKIN 2) will be assessed as a safety endpoint throughout the PREPARE-HF program.	from randomization to day prior to surgery
Safety endpoint: Syncope	Syncope due to hypotension or bradycardia will be assessed as a safety endpoint throughout the PREPARE-HF program.	from randomization to day prior to surgery
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.	from randomization to day prior to surgery
Safety endpoint: New permanent contraindication to surgery	New permanent contraindication to surgery will be assessed as a safety endpoint throughout the PREPARE-HF program.	from randomization to day prior to surgery
Safety endpoint: No need for cardiac surgery	No need for cardiac surgery will be assessed as a safety endpoint throughout the PREPARE-HF program.	from randomization to day prior to surgery

Collaborators and Investigators

• Sponsor: Medical University Innsbruck
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2026
• Primary Completion (Estimated): April 16, 2029
• Study Completion (Estimated): January 1, 2034

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Telemedicine; Perioperative Care; cardiac surgery; heart failure; Cardiac Surgical Procedures; Remote Patient Monitoring; Preoperative Exercise; Telemedically Assisted optimization program; prehab
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 1169/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: following publication of primary and secondary results
• IPD Sharing Access Criteria: Data will be shared upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No