Frailty SyndromeNCT07071142
Frailty and Outcomes in Older Heart Failure Patients With Ejection Fraction >40%
An observational study of Frailty Syndrome and Heart Failure and Mildly Reduced Ejection Fraction, run by Duyen Nguyen Hoang Mai at 2 sites in Vietnam.
Trial summary
This study aims to investigate the prevalence of frailty and its association with six-month clinical outcomes in elderly patients with heart failure and left ventricular ejection fraction greater than 40%. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Frailty Syndrome, Heart Failure and Mildly Reduced Ejection Fraction, Heart Failure and Preserved Ejection Fraction
- How many people
- 301 participants
- Where
- 2 sitesVietnam
- Study dates
- 1 Jun 2025to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elderly patients (≥60 years) with heart failure and left ventricular ejection fraction >40%, attending the cardiology outpatient clinics at Thong Nhat Hospital and the Heart Failure Clinic at University Medical Center, Ho Chi Minh City, Vietnam, during the study period.
Who may be able to join
- Diagnosis of heart failure with left ventricular ejection fraction >40% (per ESC 2021 guidelines).
- 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.
Who cannot join
- Terminal illness with life expectancy <6 months due to other causes as assessed by the investigator.
- 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.
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites
Thong Nhat Hospital - Cardiology Outpatient Clinic
Ho Chi Minh City, Ho Chi Minh, 700000
University Medical Center Ho Chi Minh City - Heart Failure Clinic
Ho Chi Minh City, Ho Chi Minh, 700000
About this study
Official title: Frailty and 6-Month Clinical Outcomes in Elderly Patients With Heart Failure and Left Ventricular Ejection Fraction >40%
This study aims to investigate the prevalence of frailty and its association with six-month clinical outcomes in elderly patients with heart failure and left ventricular ejection fraction greater than 40%. Elderly patients diagnosed with heart failure will be assessed for frailty status and followed up for six months to evaluate outcomes such as hospitalization and mortality. The study is observational and will help improve understanding of the impact of frailty on the prognosis of heart failure patients with ejection fraction >40%.
Read the detailed description
This observational cohort study aims to evaluate the prevalence of frailty and its association with six-month clinical outcomes, including hospitalization and mortality, in elderly patients with heart failure (HF) and left ventricular ejection fraction (LVEF) >40%.
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
- Frailty Syndrome, Heart Failure and Mildly Reduced Ejection Fraction, Heart Failure and Preserved Ejection Fraction
- Keywords
- frailty, heart failure, Elderly, outcome, outpatient, age over 60, EF>40%, ejection fraction above 40%
- Medical subject headings
- Frailty, Heart Failure, Heart Failure, Diastolic
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of All-Cause Mortality or Hospitalization
The number of participants who experience any of the following within 6 months after enrollment: all-cause mortality, cardiovascular mortality, all-cause hospitalization, or hospitalization for heart failure. The composite outcome includes either death or hospitalization from any cause. Events are verified from medical records and caregiver interviews.
Measured: 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Jun 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frailty SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 301 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duyen Nguyen Hoang Mai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Duyen Nguyen Hoang Mai, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071142
- Sponsor's protocol ID
- NT62722030
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Information Security
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty and 6-Month Clinical Outcomes in Elderly Patients With Heart Failure and Left Ventricular Ejection Fraction >40%
- ClinicalTrials.gov ID
- NCT07071142
- Acronym / sponsor ID
- NT62722030
- Conditions
- Frailty Syndrome, Heart Failure and Mildly Reduced Ejection Fraction, Heart Failure and Preserved Ejection Fraction
- Keywords
- frailty, heart failure, Elderly, outcome, outpatient, age over 60, EF>40%, ejection fraction above 40%
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 301 participants (estimated)
- Lead sponsor
- Duyen Nguyen Hoang MaiUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the prevalence of frailty and its association with six-month clinical outcomes in elderly patients with heart failure and left ventricular ejection fraction greater than 40%. Elderly patients diagnosed with heart failure will be assessed for frailty status and followed up for six months to evaluate outcomes such as hospitalization and mortality. The study is observational and will help improve understanding of the impact of frailty on the prognosis of heart failure patients with ejection fraction >40%.
Detailed description
This observational cohort study aims to evaluate the prevalence of frailty and its association with six-month clinical outcomes, including hospitalization and mortality, in elderly patients with heart failure (HF) and left ventricular ejection fraction (LVEF) >40%.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly patients (≥60 years) with heart failure and left ventricular ejection fraction >40%, attending the cardiology outpatient clinics at Thong Nhat Hospital and the Heart Failure Clinic at University Medical Center, Ho Chi Minh City, Vietnam, during the study period.
Key inclusion criteria (5 listed)
- Diagnosis of heart failure with left ventricular ejection fraction >40% (per ESC 2021 guidelines).
- 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.
Key exclusion criteria (4 listed)
- Terminal illness with life expectancy <6 months due to other causes as assessed by the investigator.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite of All-Cause Mortality or Hospitalization
Time frame: 6 months after enrollment
The number of participants who experience any of the following within 6 months after enrollment: all-cause mortality, cardiovascular mortality, all-cause hospitalization, or hospitalization for heart failure. The composite outcome includes either death or hospitalization from any cause. Events are verified from medical records and caregiver interviews.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: No. Information Security
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty Syndrome and Heart Failure and Mildly Reduced Ejection Fraction, run by Duyen Nguyen Hoang Mai at 2 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of All-Cause Mortality or Hospitalization (time frame: 6 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.