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

February 17, 2026 updated by: Medical University Innsbruck

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
162

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Can Gollmann-Tepeköylü, Prof.
  • Phone Number: +4351250480466
  • Email: can.gt@i-med.ac.at

Study Contact Backup

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:
        • Principal Investigator:
          • Can Gollmann-Tepeköylü, Prof.
        • Principal Investigator:
          • Gerhard Pölzl, Prof.
        • Principal Investigator:
          • Christian Puelacher, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:
  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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hierachical Endpoint Perioperative Outcome: 30-day mortality
Time Frame: assessed from randomization through 30 days post-surgery,
All-cause mortality from randomization to 30 days post-surgery
assessed from randomization through 30 days post-surgery,
Hierachical Endpoint Perioperative Outcome: ECMO
Time Frame: assessed from surgery until 30 days post-surgery
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
Time Frame: assessed from surgery until 30 days post-surgery
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
Time Frame: assessed from surgery until 30 days post-surgery.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Preoperative adverse events: death
Time Frame: will be assessed on day prior to surgery
Death prior to surgery
will be assessed on day prior to surgery
Preoperative adverse events: hospitalization
Time Frame: will be assessed on day prior to surgery
Cardiovascular related hospitalization prior to surgery
will be assessed on day prior to surgery
Preoperative adverse events: urgent surgery necessary
Time Frame: will be assessed on day prior to surgery
Urgent cardiac surgery necessary before scheduled surgery date
will be assessed on day prior to surgery
Perioperative outcome: 30-day mortality
Time Frame: will be assessed on day 30 after surgery
30-day mortality after surgery
will be assessed on day 30 after surgery
Perioperative outcome: ECMO
Time Frame: will be assessed on day 30 after surgery
Need for extracorporeal membrane oxygenation (ECMO) within 30 days post-surgery
will be assessed on day 30 after surgery
Perioperative outcome: hemodialysis or ultrafiltration
Time Frame: will be assessed on day 30 after surgery
Need for hemodialysis or ultrafiltration within 30 days post- surgery
will be assessed on day 30 after surgery
Perioperative outcome: days on ICU
Time Frame: will be assessed on day 30 after surgery
Duration of stay (days) on intensive care unit within 30 days post-surgery
will be assessed on day 30 after surgery
Preoperative risk assessment
Time Frame: assessed at randomization and on day before surgery
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)
Time Frame: assessed at randomization an on day prior to surgery
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
Time Frame: will be assessed within the 5-years after surgery
5-year mortality after surgery
will be assessed within the 5-years after surgery
EQ-5D-5L
Time Frame: from randomization to postoperative visit at 5 years post-surgery
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
Time Frame: from randomization to postoperative visit at 5 years post-surgery
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
Time Frame: assessed at randomization and on day before surgery
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
Time Frame: assessed at randomization and on day prior to surgery
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
Time Frame: assessed at randomization and on day prior to surgery
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
Time Frame: assessed at randomization and on day prior to surgery
Changes in NT-proBNP values from baseline to preoperative visit will be evaluated.
assessed at randomization and on day prior to surgery
Kidney function
Time Frame: assessed at randomization and on day prior to surgery
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
Time Frame: daily from the day of surgery until 30 days after surgery, on each day the patient is in the intensive care unit
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
Time Frame: from randomization to postoperative visit at 5 years post-surgery
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
Time Frame: assessed from surgery until 30 days post-surgery
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
Time Frame: from randomization to postoperative visit at 5 years post-surgery
Changes in number of smokers from baseline from each time point.
from randomization to postoperative visit at 5 years post-surgery
ECHO
Time Frame: assessed at randomization and on day prior to surgery
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety endpoint: Hyperkalemia
Time Frame: from randomization to day prior to surgery
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
Time Frame: from randomization to day prior to surgery
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
Time Frame: from randomization to day prior to surgery
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
Time Frame: from randomization to day prior to surgery
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
Time Frame: from randomization to day prior 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
Time Frame: from randomization to day prior to 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University Innsbruck

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 16, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2034

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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