NCT05416879 Lifestyle Behaviours of Women Newly Diagnosed With Heart Failure
| NCT ID | NCT05416879 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Newcastle University |
| Condition | Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-05-05 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2022-05-05 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Heart Failure occurs when the heart's ability to pump blood is reduced. Heart failure can lead to symptoms of breathlessness, fatigue and ankle swelling, and result in health complications including damage to other organs (e.g. kidneys), reduced function and quality of life. Although the symptoms of heart failure are similar for men and women, there are sex differences. Lifestyle behaviours such as physical activity are important modifiable risk factor for heart failure. Women continue to be underrepresented in heart failure studies and treatment guidelines are male-derived due to these disparities in recruitment. The purpose of the present study is to evaluate the physical activity levels, sedentary behaviour, sleep and quality of life and understand the barriers and facilitators to these lifestyle behaviours in women newly diagnosed with heart failure.
Eligibility Criteria
Inclusion Criteria: * Adult women with a new diagnosis of heart failure after referral to the RVI Heart Failure Diagnostic Clinic; * Able to walk and perform activities of daily living independently; * New York Heart Association functional class II-IV; * Willingness to undertake physical activity monitoring; * Willingness to participate in a semi-structured interview (this is optional and the participant will be able to participate in the study if they choose not to take part in the interview); * Ability to read, write and converse in English without the support of an interpreter; * Able to provide written informed consent. Exclusion Criteria: * Male; * Already diagnosed with heart failure; * Presented with severe symptoms requiring urgent assessment and stabilisation (e.g. breathless at rest, hypotension, confusion); * Major co-morbidity or other alternative diagnoses of no obvious acute and self-limiting cause (e.g. malignancy, severe respiratory disease, mental health problem); * Severe physical disability preventing them to function independently; * Clinically unstable with recent changes in medication; * Unable to provide informed consent.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05416879 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05416879 currently recruiting?
Yes, NCT05416879 is actively recruiting participants. Contact the research team at sarah.charman@newcastle.ac.uk for enrollment information.
Where is the NCT05416879 trial being conducted?
This trial is being conducted at Newcastle upon Tyne, United Kingdom.
Who is sponsoring the NCT05416879 clinical trial?
NCT05416879 is sponsored by Newcastle University. The trial plans to enroll 40 participants.
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