Predicting Outcomes in Atrial Fibrillation and Heart Failure (PrOAF-HF)

PrOAF-HF will aim to test if rhythm control delivered through catheter ablation in patients in whom it is not clear whether atrial fibrillation or heart failure were the first disease results in a greater improvement in left ventricular ejection fraction (LVEF) compared with patients where heart failure was diagnosed first with no evidence of AF.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; Atrial Fibrillation

Detailed Description

Heart failure is a chronic disease affecting half a million patients in the UK. Up to 40% of patients with heart failure also suffer from atrial fibrillation. A subgroup of patients with atrial fibrillation and heart failure have tachycardia induced cardiomyopathy and benefit from significant improvement of the left ventricular function with restoration of sinus rhythm. Currently those patients can only be identified based on their response to treatment. Investigators aim to improve the treatment of AF-HF patients. The group will develop a robust modelling framework for simulating the hearts of AF-HF patients' hearts to predict patients' response to therapy and infer patient history. This modelling framework will enable integration of predictive simulations into clinical study design where the inferred initiating disease and predicted patient response to therapy are tested for selecting either rate or rhythm control in AF-HF patients.

The primary objective is to test if rhythm control delivered through catheter ablation in patients where either the index disease is unclear or where AF was diagnosed prior to the onset of HF improves LVEF more than in patients where HF was diagnosed first with no evidence of AF.

The secondary objectives are to examine whether the ability to terminate AF during pulmonary vein isolation is influenced by the identified index disease and to determine whether the identified index disease affects AF recurrence rate at 6 months and/or burden post ablation. This study will also identify whether the index disease affects pressure measurements as predictors of change in ejection fraction, hospitalisation, and death rates during the follow up period.

This will be a non-interventional cohort study. Routinely acquired clinical data collected during pre-procedure work up will be accessed for research purposes including: 24-48 hour ambulatory (Holter) monitoring, electrocardiograph (ECG) in AF and in sinus rhythm if available; echocardiography, and clinical history and examination details.

Additionally, an atrial cardiac magnetic resonance imaging (MRI) scan will be performed including assessment of atrial structure, function, fibrosis and epicardial fat burden. Symptom questionnaires will be performed During the ablation procedure, additional time will be taken to perform electrophysiological assessment in all four chambers of the heart.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Magdalena Klis, MD; Phone Number: 56308 02071887188; Email: magda.klis@kcl.ac.uk

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with diagnosis of both heart failure and atrial fibrillation, listed for atrial fibrillation ablation will be recruited for the study.

Description

Inclusion Criteria:

• Symptomatic persistent AF
• LVEF ≤40% prior to commencement of treatment
• NYHA class ≥2
• Patient must have been commenced on guideline directed medical therapy (GDMT)
• Patient planning to proceed to radiofrequency atrial fibrillation ablation
• Age 18-80 years
• Able and willing to provide written informed consent

Exclusion Criteria:

• Any clinical contra-indication to ablation
• Any disease limiting life expectancy to <1 year
• Potential participant currently pregnant or breast feeding
• Contraindication to MRI
• Paroxysmal or permanent AF
• Unable to understand verbal or written explanations given in English

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
HF index disease; Patients with no history of atrial fibrillation at the time of first diagnosis of heart failure
Unclear index disease; Patients in whom the index disease is unknown or in whom atrial fibrillation is the index disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in LVEF	Change in left ventricular ejection fraction measured on echocardiography	6 months post ablation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate change in LVEF	Change in left ventricular ejection fraction on echocardiography	Immediately post procedure
AF recurrence	Presence of AF	6 months post ablation
Termination of AF during the procedure	Termination of AF during the ablation procedure	Intraprocedural
Hospitalization	Hospitalization for any reason	6 months
Death	Death of any cause and cardiovascular death	6 months
Pressure measurements as predictors of change in LVEF	Invasive measurements of all four chambers pressure changes during the ablation	Intraprocedural measurements - change in LVEF as above
Change in atrial fibrillation burden	Change in atrial fibrillation burden assessed on a continuous Holter monitor	6 months post ablation
Change in symptoms	Change in quality of lide questionnaire scores	6 months post ablation

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: May 13, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 20, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: atrial fibrillation; heart failure; ablation; HF; AF; rhythm control
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Failure; Atrial Fibrillation
• Other Study ID Numbers: 318987

Drug and device information, study documents

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