Frailty and Outcomes in Older Heart Failure Patients With Ejection Fraction >40%
NCT ID: NCT07071142
Last Updated: 2025-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
301 participants
OBSERVATIONAL
2025-06-01
2026-11-30
Brief Summary
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Detailed Description
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The study is conducted at the Cardiology outpatient clinics of Thong Nhat Hospital and the Heart Failure Clinic of the University Medical Center, Ho Chi Minh City, Vietnam. A total of approximately 301 patients aged ≥60 years with HF and LVEF \>40% (per ESC 2021 criteria) will be enrolled. Baseline assessments include demographic and clinical characteristics, geriatric syndromes, and laboratory findings. Frailty will be assessed using Fried criteria; functional status using Katz ADL and Lawton IADL; nutritional status using the Mini Nutritional Assessment (MNA); depression using the Geriatric Depression Scale-15 (GDS-15); and polypharmacy, comorbidities, and falls will also be recorded.
Participants will be followed for six months to collect data on hospitalizations, mortality, and other adverse clinical outcomes. Data collection will be performed by trained investigators using standardized case report forms (CRFs) and entered into a secure electronic database. Data will undergo regular quality checks for accuracy, completeness, and consistency, with predefined range and logic checks, and source data verification against medical records for a random sample of participants.
Standard Operating Procedures (SOPs) are implemented to ensure uniformity in patient recruitment, informed consent, data collection, follow-up, and adverse event reporting. A data dictionary describing all variables, coding schemes, and normal reference ranges has been developed and will be maintained. Missing data will be documented and addressed using appropriate imputation or sensitivity analyses as outlined in the statistical analysis plan (SAP).
The sample size of approximately 301 participants is based on an expected frailty prevalence of \~50% in this population, allowing estimation with acceptable precision and adequate power to detect associations with outcomes. Statistical analyses will include descriptive statistics, Kaplan-Meier survival analysis, and multivariable regression modeling to assess the relationship between frailty and clinical outcomes while adjusting for potential confounders.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Attending outpatient cardiology clinics at Thong Nhat Hospital or Heart Failure Clinic at University Medical Center, Ho Chi Minh City during the study period.
* Vietnamese nationality.
* Able to communicate or have a caregiver who understands the patient's condition.
* Willing and able to provide informed consent.
Exclusion Criteria
* Severe dementia or severe mental illness preventing accurate interview or follow-up.
* Severe visual or hearing impairment affecting data collection.
* Unable to provide reliable medical history.
60 Years
ALL
No
Sponsors
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Duyen Nguyen Hoang Mai
OTHER
Responsible Party
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Duyen Nguyen Hoang Mai
Resident Physician
Locations
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Thong Nhat Hospital - Cardiology Outpatient Clinic
Ho Chi Minh City, Ho Chi Minh, Vietnam
University Medical Center Ho Chi Minh City - Heart Failure Clinic
Ho Chi Minh City, Ho Chi Minh, Vietnam
Countries
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Other Identifiers
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NT62722030
Identifier Type: -
Identifier Source: org_study_id
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