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临床试验/NCT07205679
NCT07205679尚未招募不适用

Cardiovascular Performance and Exercise Response in Patients With Persistent or Permanent Atrial Fibrillation and Heart Failure Pre and Post Cardioversion or Pace and Ablate

Habib Khan0 个研究点目标入组 40 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
Habib Khan
入组人数
40
主要终点
Exercise duration

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Exercise duration

时间窗: 1 month

Peak oxygen update

时间窗: 1 month

Peak oxygen uptake achieved during a symptom-limited incremental exercise test to task failure.

B-type Natriuretic Peptide (BNP) Test

时间窗: 1 month

次要结局

  • EuroQol (EQ-5D-5L)(1 month)
  • Rate of Perceived exertion change during exercise(1 month)
  • Change in maximal HR during exercise(1 month)
  • V̇O2peak change(1 month)
  • Change in lactate threshold(1 month)
  • Kansas City Cardiomyopathy Questionnaire(1 month)

研究者

发起方
Habib Khan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Habib Khan

MBBS, PhD

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

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