Diastology-Guided Management of Decompensated Heart Failure

Study Overview
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Brief Summary
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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.

Official Title
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DiastologY-Guided MaNAgement of DecoMpensated Heart Failure: A Pilot RandomIzed, Controlled Trial

Conditions
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Heart Failure, Diastolic Dysfunction

Intervention / Treatment
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* Diagnostic Test: Diastology
* Behavioral: Diastology-Guided Diuresis
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years at the time of enrolment Decompensated heart failure with reduced ejection fraction (≤40%) Sinus rhythm without conduction abnormalities (second-degree Mobitz II, third-degree, permanent pacemaker) Written informed consent from either the patient or a substitute decision maker Exclusion Criteria: Mitral annular calcification (at least moderate or severe) Moderate or severe aortic or mitral valvular heart disease, or history of prosthetic mitral valve Atrial fibrillation or flutter History of non-diagnostic echocardiogram Hemodialysis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diastology-Guided Management<br>Participants in this arm will undergo a focused echocardiogram every 24 hours. The degree of diastolic dysfunction will be reported to the healthcare team. If the degree of diastolic dysfunction is greater than or equal to grade 2, the research team will recommend escalating the diuretic regimen if either (1) urine output is less than 4,000 mL over 24 hours or (2) weight loss is less than 2 kg over 24 hours. If the degree of diastolic dysfunction is grade 1, the research team will recommend transitioning to or discontinuing oral diuresis. | Diagnostic Test: Diastology<br>* We will follow American Society of Echocardiography criteria to determine the degree of diastolic dysfunction after performing each focused echocardiogram.<br>Behavioral: Diastology-Guided Diuresis<br>* 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.<br>|
| Active Comparator: Usual Care<br>Participants in this arm will also undergo a focused echocardiogram every 24 hours. However, the results of these echocardiograms will not be available for clinical decision-making. Instead, participants will receive usual care by the healthcare team without daily hemodynamic parameters from a study echocardiogram. | Diagnostic Test: Diastology<br>* We will follow American Society of Echocardiography criteria to determine the degree of diastolic dysfunction after performing each focused echocardiogram.<br>Behavioral: Usual Care<br>* Clinicians will rely on usual care metrics and parameters to guide diuresis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Rate | This is calculated as the number of participants enrolled in the study per month. | 12 months (anticipated study duration) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance with Echocardiograms | This is calculated as the number of echocardiograms completed divided by the number scheduled as per the study protocol. | 12 months (anticipated study duration) | 
| Interpretability of Echocardiograms | This is calculated as the number of studies without indeterminate diastolic dysfunction divided by the total number of studies performed. | 12 months (anticipated study duration) | 
| Adherence to Protocol Recommendations | 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. | 12 months (anticipated study duration) | 
| Follow-Up at 30 and 90 Days | 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. | 12 months (anticipated study duration) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diastology, echocardiography, heart failure