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Patients With Heart Failure Undergoing Cardiac SurgeryPREPARE-HFNCT07391683

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

A study testing PREPARE-HF disease management program, which includes: in people with Patients With Heart Failure Undergoing Cardiac Surgery, run by Medical University Innsbruck at 1 site in Austria.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PREPARE-HF disease management program, which includes:
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
1 siteAustria
Study dates
16 Feb 2026to 1 Jan 2034
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Can Gollmann-Tepeköylü, Prof. contact

+4351250480466

can.gt@i-med.ac.at

Leo Winter-Pölzl, MD contact

+4351250484591

leo.poelzl@i-med.ac.at

Austria1 site, 1 recruiting
  • Medical University of Innsbruck - Department of Cardiology & Department of Cardiac Surgery

    Innsbruck, Tyrol, 6020

    Can Gollmann-Tepeköylü, Prof., +43 512 504 80466, can.gt@i-med.ac.at

    Leo Winter-Pölzl, MD, +43 512 504 84591, leo.poelzl@i-med.ac.at

    Recruiting

Other trials in Austria

About this study

Official title: 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.

Read the 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.

Being tested
PREPARE-HF disease management program, which includes:
Keywords
cardiac surgery, heart failure, Telemedically Assisted optimization program, prehab, Cardiac Surgical Procedures, Perioperative Care, Preoperative Exercise, Remote Patient Monitoring, Telemedicine
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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
Study groups in NCT07391683
Study groupRoleWhat they receive
Control arm - Standard of care treatmentNo interventionReceives standard preoperative care until surgery.
PREPARE-HFExperimentalPreoperative Heart Failure Optimization and Telemedicine Integration
Receives: Other: PREPARE-HF disease management program, which includes:

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hierachical Endpoint Perioperative Outcome: 30-day mortality

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: assessed from surgery until 30 days post-surgery.

Secondary outcomes (22)
  1. Preoperative adverse events: death

    Death prior to surgery

    Measured: will be assessed on day prior to surgery

  2. Preoperative adverse events: hospitalization

    Cardiovascular related hospitalization prior to surgery

    Measured: will be assessed on day prior to surgery

  3. Preoperative adverse events: urgent surgery necessary

    Urgent cardiac surgery necessary before scheduled surgery date

    Measured: will be assessed on day prior to surgery

  4. Perioperative outcome: 30-day mortality

    30-day mortality after surgery

    Measured: will be assessed on day 30 after surgery

  5. Perioperative outcome: ECMO

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

    Measured: will be assessed on day 30 after surgery

  6. Perioperative outcome: hemodialysis or ultrafiltration

    Need for hemodialysis or ultrafiltration within 30 days post- surgery

    Measured: will be assessed on day 30 after surgery

  7. Perioperative outcome: days on ICU

    Duration of stay (days) on intensive care unit within 30 days post-surgery

    Measured: will be assessed on day 30 after surgery

  8. Preoperative risk assessment

    Change in EuroSCORE II (estimated 30-day mortality, %) from randomization to the pre-operative day.

    Measured: assessed at randomization and on day before surgery

  9. 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.

    Measured: assessed at randomization an on day prior to surgery

  10. 5-year mortality

    5-year mortality after surgery

    Measured: will be assessed within the 5-years after surgery

  11. 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.

    Measured: from randomization to postoperative visit at 5 years post-surgery

  12. 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.

    Measured: from randomization to postoperative visit at 5 years post-surgery

  13. 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.

    Measured: assessed at randomization and on day before surgery

  14. 6-minute walk test

    Changes in 6-minute walk test from baseline to preoperative visit will be evaluated.

    Measured: assessed at randomization and on day prior to surgery

  15. 1-minute sit to stand test

    Changes in 1-minute sit to stand test from baseline to preoperative visit will be evaluated.

    Measured: assessed at randomization and on day prior to surgery

  16. NT-proBNP

    Changes in NT-proBNP values from baseline to preoperative visit will be evaluated.

    Measured: assessed at randomization and on day prior to surgery

  17. Kidney function

    Changes in creatinine levels and eGFR from baseline to preoperative visit will be evaluated.

    Measured: assessed at randomization and on day prior to surgery

  18. 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.

    Measured: daily from the day of surgery until 30 days after surgery, on each day the patient is in the intensive care unit

  19. 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.

    Measured: from randomization to postoperative visit at 5 years post-surgery

  20. red blood concentrates

    The necessity for red blood cell concentrates during surgery and within the first 30 days after surgery will be evaluated.

    Measured: assessed from surgery until 30 days post-surgery

  21. Smoking status

    Changes in number of smokers from baseline from each time point.

    Measured: from randomization to postoperative visit at 5 years post-surgery

  22. ECHO

    Changes in echocardiographic parameters (LV-EF; TAPSE; Severity of valvular heart disease) from baseline to preoperative visit will be evaluated.

    Measured: assessed at randomization and on day prior to surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2026
  2. Study start16 Feb 2026
  3. Primary completion16 Apr 2029 (estimated)
  4. Study completion1 Jan 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
162 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07391683
Sponsor's protocol ID
1169/2025
Acronym
PREPARE-HF
Status last verified
Dec 2025
First submitted
7 Jan 2026
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing PREPARE-HF disease management program, which includes: in people with Patients With Heart Failure Undergoing Cardiac Surgery, run by Medical University Innsbruck at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Can Gollmann-Tepeköylü, Prof. (+4351250480466, can.gt@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hierachical Endpoint Perioperative Outcome: 30-day mortality (time frame: assessed from randomization through 30 days post-surgery,). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.

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