Breathing-linked pacemaker pacing after bypass surgery for heart failure with reduced ejection fraction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human, multicentre, randomized controlled trial compares respiratory sinus arrhythmia (RSA)–modulated atrial pacing to standard monotonic atrial pacing in patients with HFrEF undergoing on-pump CABG. Participants receive the assigned pacing for up to 10 days while monitored closely in hospital, with baseline testing before surgery and a phone follow-up at one month. The primary outcome is safety measured by arrhythmia episodes, and secondary outcomes include measures of cardiac function, cardiac output, and apnoea episodes. The trial aims to see whether restoring breathing-linked heart rate variability improves short-term postoperative cardiac performance without increasing risk.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult patients (≥ 22 years) selected for isolated, on-pump coronary artery bypass graft (CABG)
* Established diagnosis of heart failure with reduced ejection fraction (HFrEF).
* Elective or urgent admission routes
* Echocardiography assessment of left ventricular ejection fraction (EF) of 20%-40% (within 1 month of planned surgery)
* Sinus rhythm
* Any number of coronary vessels replaced. Must include left anterior descending artery.
* Able to provide written informed consent

Exclusion Criteria:

* Requirement for concurrent valve replacement surgery.
* Off-pump CABG.
* Emergency CABG
* History of paroxysmal or permanent atrial fibrillation or flutter
* History of atrioventricular-node dependent tachycardia
* Patients lacking capacity to consent
* Patient testing positive for Covid-19 within 14 days of intended CABG (PCR or lateral flow test)
* Intrinsic resting heart rate \> 100bpm
* Pregnancy
* Implanted pacemaker or defibrillator
* Failure to obtain Uscom signals

Where it's running

• Royal Adelaide Hospital
  Adelaide, South Australia, Australia Recruiting
• Monash Health
  Melbourne, Victoria, Australia Recruiting
• Waikato Hospital
  Hamilton, New Zealand Recruiting

Study contacts

• Principal investigator: Martin Stiles, MB ChB — Waikato Hospital, Hamilton, New Zealand
• Study coordinator: Flora Yuen, BSc
• Email: flora.yuen@avaniaclinical.com
• Phone: +61 438 890 650

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Yoga-based cardiac rehabilitation for heart failure with reduced ejection fraction

  This trial tests whether a yoga-based rehabilitation program can help people with heart failure and reduced ejection fraction compared with an educational program.

  Recruiting at 12 sites Centre for Chronic Disease Control, India · Dharwad, Karnataka and 15 other locations · NCT07817589

• Lumacaftor to improve cerebral blood flow in heart failure with reduced ejection fraction

  This study tests whether lumacaftor can improve brain blood flow and thinking abilities in adults with a certain type of heart failure.

  Recruiting Phase 2 Qanatpharma AG · Toronto, Ontario and 1 other locations · NCT07695090

• Stepwise withdrawal of ARNI and SGLT2i in HF with normalized ejection fraction

  This trial tests whether gradually stopping ARNI and SGLT2i is safe for people whose heart function has recovered after fixing a reversible heart‑disease cause.

  Recruiting Phase 4 Keimyung University Dongsan Medical Center · Daegu, Daegu and 4 other locations · NCT07631156

• Ring-style blood pressure bracelet test compared with 24-hour monitoring in people with HFrEF

  A ring-type blood pressure device is being tested to see if its 24-hour readings match those from standard ambulatory monitoring in adults with heart failure and reduced ejection fraction.

  Recruiting Keimyung University Dongsan Medical Center · Daegu · NCT07626879

• Diet and exercise plan to help people with heart failure and preserved heart function.

  This study tests whether a DASH-style, high-protein diet, resistance exercise, or both can help build muscle and improve fitness and quality of life in people with heart failure and reduced ejection fraction.

  Recruiting Medical University of Silesia · Zabrze, Silesian Voivodeship · NCT07595809

• HFrEF polypill strategy in Sri Lanka

  This study tests whether giving a heart failure polypill can reduce death from heart disease and hospitalizations in adults with HFrEF in Sri Lanka, compared with usual care.

  Recruiting at 10 sites Phase 3 Washington University School of Medicine · Kandy, Central Province and 11 other locations · NCT07569640

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.