Diastology-Guided Management of Decompensated Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-06

Study Completion Date

2024-07-31

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.

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Detailed Description

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Conditions

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Heart Failure Diastolic Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Diastology-Guided Management

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.

Group Type EXPERIMENTAL

Diastology

Intervention Type DIAGNOSTIC_TEST

We will follow American Society of Echocardiography criteria to determine the degree of diastolic dysfunction after performing each focused echocardiogram.

Diastology-Guided Diuresis

Intervention Type BEHAVIORAL

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.

Usual Care

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.

Group Type ACTIVE_COMPARATOR

Diastology

Intervention Type DIAGNOSTIC_TEST

We will follow American Society of Echocardiography criteria to determine the degree of diastolic dysfunction after performing each focused echocardiogram.

Usual Care

Intervention Type BEHAVIORAL

Clinicians will rely on usual care metrics and parameters to guide diuresis.

Interventions

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Diastology

We will follow American Society of Echocardiography criteria to determine the degree of diastolic dysfunction after performing each focused echocardiogram.

Intervention Type DIAGNOSTIC_TEST

Diastology-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.

Intervention Type BEHAVIORAL

Usual Care

Clinicians will rely on usual care metrics and parameters to guide diuresis.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No