Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03887351
Other study ID # MP-05-2019-1682
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2019
Est. completion date November 2020

Study information

Verified date March 2019
Source Jewish General Hospital
Contact Amanda Trnkus, MSc
Phone 5143408222
Email amanda.trnkus@ladydavis.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A prospective longitudinal cohort study aimed at measuring frailty and its associated risk factors community dwelling older adults aged 65 years or older.

The geriatric domains evaluated will include: frailty status, hearing impairment, visual impairment, polypharmacy, sarcopenia, malnutrition, cognitive impairment, depression, fatigue, sleep difficulties, and disabilities.

The primary outcome is all-cause mortality at 1-year post enrollment.


Description:

The overarching research question is as follows: Is frailty predictive of patient-centered outcomes in older adults with heart failure (HF)? Hypotheses regarding this research question are: 1) Frailty is associated with increased 12-month mortality, 2) Frailty is associated with increased 3-month mortality or unplanned hospitalization, 3) Frailty is associated with lower baseline health-related quality of life (HrQOL), and 4) Frailty is associated with worsening HrQOL at 3 months.

There are three specific study objectives. 1) To compare the ability of various frailty measures to predict all-cause mortality, hospitalizations, and HrQOL in patients attending an outpatient HF clinic. 2) To examine the determinants of longitudinal changes in frailty measures over time. Lastly, 3) To examine the clinical and frailty related determinants of fatigue in older adults

A prospective longitudinal cohort study will be conducted at a specialized heart failure (HF) clinic at the Jewish General Hospital (JGH) and Royal Victoria Hospital (RVH). The study aims to measure frailty and its associated risk factors in community dwelling individuals, aged 65 years or older and who have been diagnosed with HF (preserved or reduced ejection fraction) for at least 3 months. The multi-domain geriatric assessment will include questionnaires administered by interview, physical performance tests, body composition analysis using a bioimpedance machine, review of clinically acquired biochemical and imaging tests, and chart review. The geriatric domains evaluated will include: frailty status, hearing impairment, visual impairment, polypharmacy, sarcopenia, malnutrition, cognitive impairment, depression, fatigue, sleep difficulties, and disabilities. Baseline assessment will approximate to 40 minutes of patient contact time while follow up phone interviews at 3 and 12 months will approximate to 20 minutes. Outcome measures such as all-cause mortality, HrQOL, unplanned hospitalization will be assessed at 3 months and 1-year post enrollment.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 280
Est. completion date November 2020
Est. primary completion date November 2020
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria:

- Community dwelling outpatients

- Aged 65 years or older

- A HF diagnosis with preserved or reduced ejection fraction for at least 3 months

- Agreed to participate and signed an informed consent form

Exclusion Criteria:

- Outpatients with a recent hospital admission within 3 months

- Acutely decompensated HF status at the time of their visit

- Received intravenous (IV) diuretics or IV inotropes within 3 months

- A moribund health status with life expectancy less than 3 months

- Scheduled to undergo a major surgical or percutaneous procedure within 3 months

- Implantation of cardiac resynchronization therapy within the past 3 months or intent to place

- Patients with a history of heart transplant, currently on the transplant list or with an left ventricular device

- Severe neuropsychiatric impairments

- Non -English or French speaking

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Jewish General Hospital McGill University Health Center

Outcome

Type Measure Description Time frame Safety issue
Primary All cause mortality at 12 months All cause mortality (cardiac and non- cardiac causes) assessed using in hospital chart reviews. 12 months
Secondary All cause mortality All cause mortality (cardiac and non- cardiac causes) assessed using in hospital chart reviews. 3 months
Secondary Unplanned hospitalization at 3 and 12 months Unplanned hospitalization (In hospital stay for a minimum of 48 hours) assessed using in hospital chart reviews and self-reported hospitalization. 3 months and 12 months
Secondary Health related quality of life at 3 and 12 months measured using the Short Form Health Survey questionnaire (SF-36) The sub-scales of the SF-36 include, physical functioning, bodily pain, general health, vitality, social and functioning, mental health. 3 months and 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Recruiting NCT05654272 - Development of CIRC Technologies
Active, not recruiting NCT05896904 - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction N/A
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting NCT05631275 - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation NCT05564572 - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Recruiting NCT06340048 - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure Phase 1/Phase 2
Recruiting NCT05679713 - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed NCT04254328 - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure N/A
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Completed NCT06026683 - Conduction System Stimulation to Avoid Left Ventricle Dysfunction N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy