Skip to content

The RedHeart Study. ECG recording with the Coala Heart Monitor in patients with symptomatic palpitations – underlying arrhythmias and effects on symptoms and quality of life

ECG-registration in women with palpitations with rapid response by Coala Heart Monitor – effect on symptoms and quality of life and information on frequency of dangerous heart rhythms

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN22495299
Enrollment
900
Registered
2019-11-04
Start date
2018-06-01
Completion date
Unknown
Last updated
2021-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Palpitations Circulatory System

Interventions

After informed consent, the participants borrowed the heart monitor (Coala Heart Monitor) and were instructed via the internet on how to use it and when needed via telephone support. The participants
“How often do you experience symptoms?”,” Have you consulted the health service for your symptoms?” , “Did you get any treatment for your symptoms?”, “Did you feel that the health care staff believed

Sponsors

Karolinska Institutet
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women with symptomatic palpitations 2. Age over 18 years 3. Able to read and write Swedish fluently 4. Have a smartphone or tablet 5. Have a Swedish eAuthentification (BankID) 6. Able to handle a digital approach

Exclusion criteria

Exclusion criteria: Earlier known AF or atrial flutter (AFL)

Design outcomes

Primary

MeasureTime frame
Measured at the beginning of the study and after 2 months of ECG recording: 1. Health-related quality of life assessed using RAND-36 2. Anxiety assessed using Generalized Anxiety Disorder (GAD-7) 3. Anxiety and depression assessed using the Hospital Anxiety and Depression Scale (HAD) 4. Arrhythmia symptoms assessed using Symptoms Checklist: Frequency and Severity (SCL)

Secondary

MeasureTime frame
Prevalance of arrhythmia when having heart palpitation measured using ECG recordings during the study period of 2 months

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 16, 2026