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The D-Frail Study 1: Association between vascular endothelial dysfunction and physical frail in patients with cardiovascular comorbidities: A prospective crossectional cohort study

The D-Frail Study 1: Association between vascular endothelial dysfunction and physical frail in patients with cardiovascular comorbidities: A prospective crossectional cohort study – Interplay between vitamin D deficiency, chronic inflammation and sarcopenia

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621000058875
Enrollment
183
Registered
2021-01-25
Start date
2021-01-28
Completion date
2021-05-01
Last updated
2021-02-01

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

Conditions

None listed

Brief summary

The WSLHD HREC has approved project, certifying that the study proposal meets the requirements of the National Statement. The ethical approval for this research project is granted to be conducted at Blacktown Mount Druitt Hospital. The WSLHD HREC has been accredited by the NSW Department of Health as a lead HREC to provide the single ethical and scientific review of proposals to conduct research within the NSW public health system. This lead HREC is constituted and operates in accordance with the National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research and the CPMP/ICH Note for Guidance on Good Clinical Practice. The request to undertake the above protocol was reviewed by a subcommittee of members of the Scientific Advisory Committee (SAC) and the Human Research Ethics Committee (HREC) (Western Sydney Local Health District).

Interventions

A single-centred, prospective cross-sectional analytical study will be carried out. Patients with diagnosed Cardiovascular disease conditions will be recruited from outpatient clinics of acute care hospital. Written informed consent will be taken from all patients who are willing to participate the study at screening stage. At the time of enrolment to the study, the participants will be given a unique study identification number, which will be used to identify the participants throughout the stu

A single-centred, prospective cross-sectional analytical study will be carried out. Patients with diagnosed Cardiovascular disease conditions will be recruited from outpatient clinics of acute care hospital. Written informed consent will be taken from all patients who are willing to participate the study at screening stage. At the time of enrolment to the study, the participants will be given a unique study identification number, which will be used to identify the participants throughout the study, until study completion. No identifiable information will be used in the records. Study master list with identifiers will be securely kept separately from the list of unique IDs given to the participants and study data records. The participants will be screened for their frailty states (30 min clinical assessment involving muscle strength assessment by hand grip strength measurement, physical and cognitive function assessments, dietary intake of vitamin D and sun exposure levels assessments by questionnaires) and blood tests to assess vascular function and inflammatory markers and plasma vitamin D levels.

Sponsors

Western Sydney Local Health District
Lead SponsorGovernment body

Eligibility

Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Age greater than or equal to 45 years, Diagnosed with cardiovascular condition

Exclusion criteria

Diagnosed renal/liver diseases Pregnant or breastfeeding Severe cognitive impairment (i.e. dementia/alzheimer's disease) Diagnosed musculoskeletal disorders Unable to communicate without an interpreter

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026