Atrial Fibrillation (AF), Heart Failure With Mildly Reduced Ejection Fraction, Heart Failure With Preserved Ejection Fraction (HFPEF), Rate Control, Rhythm Control
Conditions
Brief summary
This study is testing two different ways of treating atrial fibrillation (AF) in people who also have heart failure with mildly reduced or preserved heart function. Patients will randomly be assigned to either rhythm control using catheter ablation or rate control using medicines. The pilot phase will determine if a larger study can be successfully carried out to see which approach better improves survival, reduces hospitalizations, and enhances quality of life.
Interventions
Participants randomized to this arm will undergo catheter ablation within 4 weeks of randomization. Pulmonary vein isolation is required; additional ablation strategies may be applied at investigator discretion. Guideline-directed medical therapy for atrial fibrillation and heart failure will also be provided.
DRUGRate Control Medications (beta-blockers, calcium channel blockers, digoxin)
Participants randomized to this arm will receive pharmacologic therapy to achieve guideline-recommended heart rate control (resting HR \<80 bpm, \<110 bpm with exercise). Therapy may include beta-blockers, non-dihydropyridine calcium channel blockers, or digoxin. If adequate control is not achieved with medication, AV nodal ablation and pacing may be used. Guideline-directed medical therapy for atrial fibrillation and heart failure will also be provided.
Sponsors
Nova Scotia Health Authority
Heart and Stroke Foundation of Canada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This trial is a pilot feasibility trial intended to lead into a larger, definitive trial as the trial is comparing two treatments already in clinical use.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Diagnosis of atrial fibrillation (documented on Holter, rhythm strip, or ECG) * New York Heart Association (NYHA) class II-III heart failure * Left ventricular ejection fraction (LVEF) \>40% * Meet specific NT-proBNP criteria: * If HF hospitalization within 6 months prior to screening: NT-proBNP \>200 pg/ml (if not in AF at screening) or \>600 pg/ml (if in AF at screening) * Otherwise: NT-proBNP \>300 pg/ml (if not in AF at screening) or \>900 pg/ml (if in AF at screening) * On stable guideline-directed medical therapy for ≥1 month * On stable diuretic dose for ≥2 weeks * Suitable for either ablation-based rhythm control or rate control strategy
Exclusion criteria
* Permanent atrial fibrillation diagnosis * Prior catheter ablation for atrial fibrillation * NYHA class IV heart failure * Rheumatic heart disease * Moderate or severe mitral stenosis * Mechanical mitral valve * Severe aortic stenosis or severe aortic/mitral regurgitation * Renal failure requiring dialysis * Contraindication to oral anticoagulation * Infiltrative cardiomyopathies * Complex congenital heart disease * Untreated thyroid disease * Acute coronary syndrome or coronary artery bypass surgery within 12 weeks * Participation in another clinical trial * Inability to provide informed consent * Other serious non-cardiovascular condition with life expectancy ≤1 year * Age \<18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Trial Conduct | 12 months after randomization | Recruitment rate (patients recruited per center per month) and crossover rate (percentage of participants switching study arms). Feasibility will be defined as ≥0.7 patients enrolled per center per month and ≤10% crossover. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite of Cardiovascular Mortality and Heart Failure Hospitalization | Up to 12 months post-randomization | Time to first event of cardiovascular death (due to MI, sudden cardiac death, HF, stroke, CV procedures, CV bleeding, or other CV cause) or hospitalization for heart failure (admission \>24h, ED visit, or unscheduled IV diuretic administration). |
| All-Cause Mortality | Up to 12 months | Death from any cause |
| Cardiovascular Hospitalizations and ED Visits (Non-HF) | Up to 12 months | Number of hospitalizations or emergency department visits for other cardiovascular causes, including atrial fibrillation. |
| Quality of Life: EQ-5D (Euroquol 5D Questionnaire) | Baseline, 12 months | EQ5D Will include responses from the Euroquol 5D questionnaire |
| Quality of Life: AFEQT (Atrial Fibrillation Effect on Quality of Life) Questionnaire | Baseline, 12 months | AFEQT- Atrial Fibrillation Effect on Quality of Life Questionnaire (Scored 0-100, 0 is complete disability, 100 is no disability) |
| Quality of life- KCCQ-12 (Kansas City Cardiomyopathy Questionnaire-12) | Baseline, 12 months | KCCQ-12- Kansas City Cardiomyopathy Questionnaire-12 (0-100, 0 is very poor, 100 is excellent) |
| Atrial Fibrillation Burden | Baseline, 3, 6, and 12 months | Proportion of time in atrial fibrillation as measured by Holter monitoring and symptom-triggered ECG recordings |
| Change in NT-proBNP levels | Baseline, 12 months | Change in plasma NT-proBNP levels from baseline to follow-up |
| Change in Left Ventricular Ejection Fraction (LVEF) | Baseline, 12 months | Change in LVEF as measured by echocardiography |
| Exercise Capacity (6-Minute Walk Distance) | Baseline, 12 months | Change in distance walked in 6 minutes from baseline to follow-up |
| Recruitment Metrics | Throughout 12-month recruitment | Recruitment ration of male vs. female participants, refusal rates and reasons. |
Countries
Canada
Contacts
CONTACTLaura Hamilton, BSC, MAHSR
CONTACTKatie Kawulka, BScN, RN
Outcome results
None listed