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Atrial FibrillationPrOAF-HFNCT06417242

Predicting Outcomes in Atrial Fibrillation and Heart Failure

An observational study of Atrial Fibrillation and Heart Failure, run by Guy's and St Thomas' NHS Foundation Trust.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Atrial Fibrillation, Heart Failure
How many people
80 participants
Where
No sites listed yet
Study dates
May 2024to Oct 2026
Phase
Observational
Are there results?
None posted in the registry

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

About this study

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.

Read the 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.

Keywords
ablation, atrial fibrillation, AF, heart failure, HF, rhythm control
Medical subject headings
Atrial Fibrillation, Heart Failure

What participants receive

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

Study groups in NCT06417242
Study groupRoleWhat they receive
HF index diseasePatients with no history of atrial fibrillation at the time of first diagnosis of heart failure
Unclear index diseasePatients in whom the index disease is unknown or in whom atrial fibrillation is the index disease

What is being measured

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

  1. Change in LVEF

    Change in left ventricular ejection fraction measured on echocardiography

    Measured: 6 months post ablation

Secondary outcomes (8)
  1. Immediate change in LVEF

    Change in left ventricular ejection fraction on echocardiography

    Measured: Immediately post procedure

  2. AF recurrence

    Presence of AF

    Measured: 6 months post ablation

  3. Termination of AF during the procedure

    Termination of AF during the ablation procedure

    Measured: Intraprocedural

  4. Hospitalization

    Hospitalization for any reason

    Measured: 6 months

  5. Death

    Death of any cause and cardiovascular death

    Measured: 6 months

  6. Pressure measurements as predictors of change in LVEF

    Invasive measurements of all four chambers pressure changes during the ablation

    Measured: Intraprocedural measurements - change in LVEF as above

  7. Change in atrial fibrillation burden

    Change in atrial fibrillation burden assessed on a continuous Holter monitor

    Measured: 6 months post ablation

  8. Change in symptoms

    Change in quality of lide questionnaire scores

    Measured: 6 months post ablation

Timeline

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

  1. First posted16 May 2024
  2. Study startMay 2024 (estimated)
  3. Primary completionApr 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06417242
Sponsor's protocol ID
318987
Acronym
PrOAF-HF
Status last verified
May 2024
First submitted
13 May 2024
Last updated
20 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation and Heart Failure, run by Guy's and St Thomas' NHS Foundation Trust.

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 7 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: status not confirmed, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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

Contact Magdalena Klis, MD (02071887188 ext. 56308, magda.klis@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in LVEF (time frame: 6 months post ablation). 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 20 May 2024.

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