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NCT05416879Recruiting

Lifestyle Behaviours of Women Newly Diagnosed With Heart Failure

Lifestyle Behaviours of Women Newly Diagnosed With Heart Failure: A Quantitative and Qualitative Approach

Source: ClinicalTrials.gov · Last updated 10 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
40 (estimated)
First submitted
12 May 2022
Start date
5 May 2022
Primary completion date
30 Jun 2026
Lead sponsor
Newcastle University
NCT number
NCT05416879

What you commit to

  • Study type: Observational
  • Planned participants: 40
  • From 5 May 2022 to the primary completion date, 30 Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Clinically unstable with recent changes in medication;

Other illness

  • Already diagnosed with heart failure;
  • Major co-morbidity or other alternative diagnoses of no obvious acute and self-limiting cause (e.g. malignancy, severe respiratory disease, mental health problem);

Other

  • Male;
  • Presented with severe symptoms requiring urgent assessment and stabilisation (e.g. breathless at rest, hypotension, confusion);
  • Severe physical disability preventing them to function independently;
  • Unable to provide informed consent.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Newcastle Upon Tyne Hospitals NHS Foundation Trust
Coordinator of this site? Confirm its status
Newcastle upon TyneUnited KingdomRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.