Prevention to Improve Outcomes After PVI

NCT ID: NCT05148338

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-16
• Study Completion Date: 2025-07-29

Brief Summary

Atrial fibrillation (AF) is the most common cardiac arrhythmia and has a rising prevalence due to an aging population. AF increases the patient's risk of hospitalization, heart failure and stroke and results into deterioration of quality of life. Treatment of symptomatic AF consists of either antiarrhythmic medication or a pulmonary vein isolation (PVI) catheter ablation. However, lots of patients experience recurrence of AF in the first year after PVI.

Previous studies showed that PVI outcomes depend on the presence of different treatable risk factors that influence the substrate for AF. Those risk factors include obesity, hypertension, cholesterol, diabetes mellitus, alcohol use, smoking and obstructive sleep apnea syndrome. However, research into the effect of treatment of those risk factors mainly consists of observational studies. Currently, it is not clear to what extent patients will benefit from comprehensive risk factor treatment prior to PVI in terms of ablation success and quality of life.

The aim of the current randomized controlled trial is to determine the effect of a nurse-led, technology-supported, personalized care pathway on hospital admissions for cardioversions and re-ablation in patients with AF that are referred for ablation.

Patients included in this study will be randomized to either the intervention group receiving the comprehensive risk treatment before PVI or the control group receiving standard usual care. Patients in the intervention group will visit the specialized AF nurse outpatient clinic and receive a personalized treatment plan (with a maximal duration of 6 months) including lifestyle interventions and medication. This includes sleep apnea screening with a Home Sleep Apnea Test (WatchPAT). Patients will also use the VitalHealth Engage platform. The digital platform can be used at home to report AF complaints, send home measurement and complete questionnaires. Furthermore, it supports the nurse in administering effective lifestyle changes by offering the patient personalized content and education.

Both study groups will be followed up to 12 months after ablation, during which hospital admissions for cardioversion and re-ablation are evaluated. At baseline, AFEQT, EQ5D and TBQ quality of life questionnaires will be performed. The questionnaires will be repeated prior to ablation, at 3 and 12 months after ablation. At baseline, pre-ablation and after 12 months laboratory tests (such as cholesterol) will be performed to evaluate adherence to lifestyle interventions.

Conditions

Atrial Fibrillation; Risk Reduction; Nurse's Role

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Risk intervention group

Comprehensive risk factor management at specialized AF outpatient clinic concerning blood pressure, cholesterol, glycaemic control, physical inactivity, weight control, smoking, alcohol intake and sleep apnea.

Group Type: EXPERIMENTAL

Comprehensive risk factor treatment

Intervention Type: OTHER

1. Apnea screening with Home Sleep Apnea Test. Referral to sleep physician if apnea-hypopnea index (AHI) is greater than 5

2. Weight management counseling by dietician if body mass index (BMI) is above 27 kg/m2

3. Physical activity program under supervision of physiotherapist at a specialized cardiac rehabilitation centre if BMI is over 27 or if there are complaints during exercise

4. Smoking cessation at specialized outpatient clinic

5. Blood pressure control, lipid management, glycaemic control, alcohol intake reduction by specialized AF nurse

6. Motivation and education through a digital health platform

Control group

Standard of care. Treatment by cardiologist conform existing guidelines.

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: OTHER

Standard usual care: Treatment by cardiologist conform existing guidelines

Interventions

Comprehensive risk factor treatment

1. Apnea screening with Home Sleep Apnea Test. Referral to sleep physician if apnea-hypopnea index (AHI) is greater than 5

2. Weight management counseling by dietician if body mass index (BMI) is above 27 kg/m2

3. Physical activity program under supervision of physiotherapist at a specialized cardiac rehabilitation centre if BMI is over 27 or if there are complaints during exercise

4. Smoking cessation at specialized outpatient clinic

5. Blood pressure control, lipid management, glycaemic control, alcohol intake reduction by specialized AF nurse

6. Motivation and education through a digital health platform

Intervention Type: OTHER

Standard of care

Standard usual care: Treatment by cardiologist conform existing guidelines

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with paroxysmal or persistent symptomatic atrial fibrillation referred for initial catheter ablation
• Patients should be native Dutch speakers
• Patients are able to use the VitalHealth Engage platform on their own preferred device (tablet, mobile phone, computer)
• The patient has at least one of the following risks

1. BMI ≥27 kg/m2,

2. hyperlipidaemia (LDL-cholesterol >2.6 mmol/L or total cholesterol >5.0 mmol/L),

3. hypertension (blood pressure >130/90 mmHg),

4. diabetes mellitus with HbA1c ≥53 mmol/mol,

5. active smoking,

6. excess alcohol use (>14 equivalent units of alcohol / week)

Exclusion Criteria

• Longstanding persistent atrial fibrillation (persistent AF for more than 1 year)
• Permanent atrial fibrillation
• Asymptomatic atrial fibrillation
• Prior catheter ablation
• Paroxysmal atrial fibrillation consisting of one episode with a reversible cause (e.g. fever, surgery, thyroid crisis, ischemic)
• Severe valvular heart disease
• Prior or soon foreseen implantation of cardiac device such as pacemaker or internal cardioverter defibrillator
• Unstable heart failure New York Heart Association (NYHA) IV, or heart failure necessitating admission <3 months before inclusion
• Cardiac surgery <3 months before inclusion or planned cardiac surgery
• Patient is not willing to use a mobile phone application or willing to undergo elaborate monitoring.
• Malignancy
• Life expectancy <1 year
• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role: lead

Responsible Party

Lukas Dekker

Lukas Dekker, MD PhD, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lukas Dekker, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Catharina Ziekenhuis Eindhoven

Locations

Catharina Ziekenhuis

Eindhoven, , Netherlands

Countries

Netherlands

References

Vermeer J, Vinck T, de Louw B, Slingerland S, van 't Veer M, Regis M, Jansen JM, van den Heuvel E, Dekker L. Improving outcomes of AF ablation by integrated personalized lifestyle interventions: rationale and design of the prevention to improve outcomes of PVI (POP) trial. Clin Res Cardiol. 2023 Jun;112(6):716-723. doi: 10.1007/s00392-023-02185-5. Epub 2023 Mar 31.

Reference Type: DERIVED

PMID: 37000245 (View on PubMed)

Other Identifiers

CZE2021.53

Identifier Type: -

Identifier Source: org_study_id