New ways to estimate left heart pressures in people with heart failure and atrial fibrillation

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 prospective, multicenter observational study will enroll about 400 patients with atrial fibrillation who are undergoing right or left heart catheterization. It aims to develop and validate an algorithm that uses echocardiographic and clinical parameters to distinguish normal from elevated left ventricular filling pressure with at least 80% diagnostic accuracy. Secondary goals include identifying imaging predictors of abnormal pressure elevation during exercise and finding imaging markers linked to mortality and heart-failure outcomes over three years. Echocardiography will be performed in relation to catheterization, without changing cardiovascular medications within eight hours. An exercise substudy will explore predictors of increased wedge pressure during exertion.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Atrial fibrillation (paroxysmal, persistent, or permanent)
* Scheduled for RHC or LHC for clinical reasons
* Able to undergo echocardiography and invasive pressure measurement within 8 hours
* No cardiovascular medication changes between echo and catheterization
* Written informed consent provided

Exclusion Criteria:

* Mitral stenosis or mitral annular calcification causing severe functional stenosis
* Severe mitral or severe tricuspid regurgitation
* Prosthetic mitral valve
* Atrial fibrillation with rapid ventricular response \>120 bpm
* Suboptimal echocardiographic imaging
* Conditions rendering PCWP or LVEDP unreliable
* Pregnant women
* Complex congenital heart disease
* LV assist device and patients with severe non-cardiac disease with poor prognosis
* Cardiac transplant patients
* End-stage liver disease

Where it's running

• Division of Cardiovascular & Pulmonary Diseases, Oslo University Hospital
  Oslo, Oslo, Norway Recruiting
• Cleveland Clinic
  Cleveland, Ohio, United States Not yet recruiting
• Methodist DeBakey Heart and Vascular Center
  Houston, Texas, United States Not yet recruiting
• Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium
  Aalst, Belgium Not yet recruiting
• Catholic University of Leuven
  Leuven, Belgium Not yet recruiting
• Laboratory Signal Processing and Image, Department of Cardiology
  Rennes, France Not yet recruiting

Study contacts

• Study coordinator: Lars-Egil Reine Hammersboen, Medical doctor
• Email: lerhammersboen@gmail.com
• Phone: +4790116941

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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.