Diastolic Dysfunction, Heart Failure
Conditions
Keywords
diastology, echocardiography, heart failure
Brief summary
More than 30% of people hospitalized with decompensated heart failure return to the hospital within 90 days. Emerging evidence suggests that hemodynamic monitoring with guided management may enhance prognosis and management. Hemodynamic monitoring with echocardiography using diastology and an evidence-informed therapeutic protocol have the potential to achieve this aim in a minimally invasive manner.
Interventions
DIAGNOSTIC_TESTDiastology
We will follow American Society of Echocardiography criteria to determine the degree of diastolic dysfunction after performing each focused echocardiogram.
BEHAVIORALDiastology-Guided Diuresis
If the daily urine output or weight loss are less than study-specified targets, then the research team will recommend changes to the diuretic regimen based on the degree of diastolic dysfunction.
BEHAVIORALUsual Care
Clinicians will rely on usual care metrics and parameters to guide diuresis.
Sponsors
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years at the time of enrolment 2. Decompensated heart failure with reduced ejection fraction (≤40%) 3. Sinus rhythm without conduction abnormalities (second-degree Mobitz II, third-degree, permanent pacemaker) 4. Written informed consent from either the patient or a substitute decision maker
Exclusion criteria
1. Mitral annular calcification (at least moderate or severe) 2. Moderate or severe aortic or mitral valvular heart disease, or history of prosthetic mitral valve 3. Atrial fibrillation or flutter 4. History of non-diagnostic echocardiogram 5. Hemodialysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | 12 months (anticipated study duration) | This is calculated as the number of participants enrolled in the study per month. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compliance with Echocardiograms | 12 months (anticipated study duration) | This is calculated as the number of echocardiograms completed divided by the number scheduled as per the study protocol. |
| Interpretability of Echocardiograms | 12 months (anticipated study duration) | This is calculated as the number of studies without indeterminate diastolic dysfunction divided by the total number of studies performed. |
| Adherence to Protocol Recommendations | 12 months (anticipated study duration) | This is calculated as the number of treatment decisions in the intervention arm that is aligned (increase, maintain, or decrease) with the therapeutic recommendations of the trial based on the severity of diastolic dysfunction divided by the number of studies completed. |
| Follow-Up at 30 and 90 Days | 12 months (anticipated study duration) | This is calculated as the number of participants that complete a follow-up visit with a study team member at 30 and 90 days, respectively. |
Contacts
Primary ContactKevin J Um, MD
Backup ContactEmilie P Belley-Cote, MD PhD
Outcome results
None listed