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Atrial Fibrillation (AF)PRIME-AFNCT06772207

Cardiac Rehabilitation Needs Among Individuals With Atrial Fibrillation

An observational study of Atrial Fibrillation (AF), run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this survey- and registry-based study is to learn about the cardiac rehabilitation needs of individuals with atrial fibrillation (AF). The main objectives of the study is to: 1. describe needs for CR as part of secondary prevention among individuals with AF. 2. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation (AF)
How many people
30,882 participants
Where
1 siteDenmark
Study dates
10 Jun 2025to 31 Dec 2025
How long will I take part?
1 Day
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Registry-based. The study population is drawn from Danish Health Registries and receive an online questionnaire.

Who may be able to join

  • Individuals with recidence in Denmark, 18 years of age or above, with a CPR number (personal identification number) registered with a diagnosis of incident AF in 2022 or 2023 (ICD-10: DI480*).

Who cannot join

  • Death.
  • Name- and address protection.
  • Exemtion from using digital post.
  • Living in a nursing home.
  • A diagnosis of dementia.
  • Hospital admission or ambulant contacts due to mental illness within one year before diagnosis (except depression or anxiety).
  • Individuals receiving palliative care or treatment.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Esbjerg Hospital - University Hospital of Southern Denmark

    Esbjerg

Other trials in Denmark

About this study

Official title: Cardiac Rehabilitation in Individuals With Atrial Fibrillation. A Protocol for a Danish Survey and Registry-based Study (PRIME-AF)

The goal of this survey- and registry-based study is to learn about the cardiac rehabilitation needs of individuals with atrial fibrillation (AF). The main objectives of the study is to:

  1. describe needs for CR as part of secondary prevention among individuals with AF.
  2. assess eligibility and acceptance of referral to specific CR components based on individual patient-preferences, and their overlap with identified needs.
Read the detailed description

Atrial fibrillation (AF) is the most common cardiac arrhythmia in adults globally. It poses significant public health challenges and is associated with substantial morbidity and mortality. AF affects quality of life with an enlarged symptom burden. To improve life expectancy and quality of life, medical treatment along with risk factor management and cardiac rehabilitation is needed. In many countries, referral to cardiac rehabilitation remains low. Furthermore, no guidelines or evidence provides details on whom should be referred. Thus, we do not know how many individuals with AF presents with cardiac rehabilitation needs.

This study is a survey and registry-based study. Danish health registries are used to draw a population of individuals with incident AF in 2023-2024. Following the exclusion criteria, these will receive a survey covering the described outcomes which are used to investigate needs of rehabilitation. A statistical descriptive analysis will be performed to describe needs and patient-preferences for CR components.

Keywords
Atrial Fibrillation, Cardiac rehabilitation, Needs, Secondary prevention, Primary care, Survey, Registry
Medical subject headings
Atrial Fibrillation

What participants receive

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

Study groups in NCT06772207
Study groupRoleWhat they receive
Respondents of electronic surveyPopulation with incident AF in Denmark in 2023-2024

What is being measured

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

  1. Atrial fibrillation related quality of life

    Atrial fibrillation related quality of life by ASTA HRQoL scale (The Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia).

    The ASTA HRQoL scale has 13 items and describes the arrhythmia's influence on daily life situation with a seven items physical subscale (items 1-5, 10 and 12) and a six items mental subscale (items 6-9, 11 and 13). We will be using both the total and subscale scores as recommended.

    The response alternatives from 0 to 3: "No (0), Yes, to a certain extent (1), Yes, quite a lot (2), Yes, a lot (3)". Scoring for the ASTA HRQoL total scale ranges from 0 (best possible HRQoL) to highest 39 (worst possible HRQoL). Higher scores reflect a worse effect on HRQoL due to the heart rhythm disturbance. ASTA's physical subscale ranges from 0 to 21 and the mental subscale ranges from 0 to18.

    Measured: At enrollment

  2. Atrial fibrillation related symptom burden

    AF6 questionnaire. Patients chose a number on a Likert scale from 0 to 10, where 0 means no and 10 severe symptoms or difficulties. The scores of the six questions are added into a single global score. The recall period for the instrument is the most recent 7 days.

    Measured: At enrollment

Secondary outcomes (6)

  1. General well-being

    WHO5. The WHO-5 is a five-item scale measuring well-being and life satisfaction within the past 2 weeks and the scale is operationalized using a 0-100 score, with higher values indicating a higher level of well-being and life satisfaction. Scores below 50 indicate poor well-being.

    Measured: At enrollment

  2. Anxiety

    ASS-2 has the purpose of screening for anxiety within the past 2 weeks. Higher score of ASS-2 indicates a higher symptom level of anxiety.

    Measured: At enrollment

  3. Depression

    MDI-2 has the purpose of screening for depression within the past 2 weeks. Higher score indicates a higher symptom level of depression.

    Measured: At enrollment

  4. Medicine adherence

    MARS-5 (Medication Adherence Report Scale). Items scored as 5 = never to 1 = always, i.e. high scores = high adherence. Scores are added together to form a scale score (range = 5 to 25). An adjusted mean score is calculated by dividing the scale mean by the number of items in the scale (range 1-5).

    Measured: At enrollment

  5. Risk factor status

    Obesity, physical inactivity, smoking and alcohol habits

    Measured: At enrollment

  6. Comorbidity

    Hypertension, diabetes, sleep apnoea, other cardiac diseases

    Measured: At enrollment

Timeline

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

  1. First posted13 Jan 2025
  2. Study start10 Jun 2025
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

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
Cross-sectional
Enrolment
30,882 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT06772207
Sponsor's protocol ID
PRIME-AF
Acronym
PRIME-AF
Status last verified
Oct 2026
First submitted
2 Jan 2025
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Unless follow-up studies using the same study population is planned later on, data (IPD) will not be shared.

Publications

  • Elnegaard CM, Borregaard B, Risom SS, Tveskov C, Bech M, von Bornemann Hjelmborg J, Eilso J, Hedegaard AM, Stege Bojer A, Darkner S, Albertsen AE, Joensen AM, Brandes A, Zwisler AD. Cardiac rehabilitation in atrial fibrillation: a protocol for a Danish survey and registry-based study (PRIME-AF). BMJ Open. 2025 Dec 24;15(12):e107042. doi: 10.1136/bmjopen-2025-107042.

    PubMed 41448694

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation (AF), run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.

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 1 inclusion and 7 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: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Atrial fibrillation related quality of life (time frame: At enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06772207, which also lists 1 linked publication.

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 29 Oct 2026.

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