Cardiovascular Performance and Exercise Response in Patients With Persistent or Permanent Atrial Fibrillation and Heart Failure Pre and Post Cardioversion or Pace and Ablate
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF), Heart Failure - NYHA II - IV, Pacemaker, Cardioversion. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Heart Failure (HF) and Atrial Fibrillation (AF) are two conditions that commonly occur together. Clinical guidelines consider a resting heart rate of 100-110 beats per minute (bpm) acceptable for patients with HF and AF while 72 bpm is considered the average in healthy populations. A higher resting heart rate indicates that the heart is working harder to meet bodily demands, and though it may be considered safe for patients with HF and AF to have a heart rate of 110 bpm, the investigators believe it is having a significant negative impact on patient quality of life and their ability to exercise. The current study will test exercise ability using a treadmill test before and after either a cardioversion, where the patient's heartbeat is reset using electric shocks, or a pace and ablate method, where the patient receives a pacemaker to regulate their heart rhythm and an ablation (intentional damaging) of the node that coordinates the beats within the heart. This will allow investigators to compare how the heart responds to exercise when the patient is on rate-control and anticoagulation medication therapy (before cardioversion or pace and ablate) and after the procedures. During exercise, the investigators will do a blood test that lets investigators know how efficiently the heart is working and record any symptoms experienced. The investigators will also collect information about the patient's quality of life. Using this information, the investigators hope to better understand whether the current standard of a resting heart rate of 100-110 bpm is ideal for patient quality of life.
Primary outcome measures
- Exercise duration [Time frame: 1 month]
- Peak oxygen update [Time frame: 1 month]
- B-type Natriuretic Peptide (BNP) Test [Time frame: 1 month]
Secondary outcome measures (6)
- Change in maximal HR during exercise [Time frame: 1 month]
- EuroQol (EQ-5D-5L) [Time frame: 1 month]
- Rate of Perceived exertion change during exercise [Time frame: 1 month]
- V̇O2peak change [Time frame: 1 month]
- Change in lactate threshold [Time frame: 1 month]
- Kansas City Cardiomyopathy Questionnaire [Time frame: 1 month]
Eligibility criteria
Inclusion criteria
- Age ≥ 18
- Persistent or Permanent Atrial Fibrillation
- HF - NYHA class II-IVA despite guideline-direct medical therapy
- Rate controlled
- Able to perform stress test
- Scheduled for clinical P\&A OR cardioversion
Exclusion criteria
- Creatinine >180 μmol/L or eGFR <30 mL/min/1.73 m2
- Significant valvular heart disease: Moderate to severe tricuspid regurgitation, mitral regurgitation, mitral stenosis, aortic regurgitation, aortic stenosis
- Patients who have had a TAVI, valvular surgery, or CABG within 3 months of enrolment
- Right ventricular systolic pressure >50mmHg
- Existing pacemaker
- In sinus rhythm
- Predictable vasovagal syncope to pain and sight of blood
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07205679 · 125097 · 125097