Frailty and Outcomes in Older Heart Failure Patients With Ejection Fraction >40%

NCT07071142 | Active Not Recruiting

• 1 other identifier: NT62722030
• Study Type: observational
• Target: 301
• Locations: 1 country
• Sites: 2

Brief 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%. 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%.

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%

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months after enrollment

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duyen Nguyen Hoang Mai: lead

Study Sites (2)

Thong Nhat Hospital - Cardiology Outpatient Clinic

Ho Chi Minh City, Ho Chi Minh, 700000, Vietnam

Location

University Medical Center Ho Chi Minh City - Heart Failure Clinic

Ho Chi Minh City, Ho Chi Minh, 700000, Vietnam

Location

MeSH Terms

Conditions

Frailty; Heart Failure; Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 17, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

VN (2)