Diastology-Guided Management of Decompensated Heart Failure

Not Applicable

Not yet recruiting

• Conditions: Diastolic Dysfunction; Heart Failure
• Interventions: Diagnostic Test: Diastology; Behavioral: Diastology-Guided Diuresis; Behavioral: Usual Care

• Registration Number: NCT06131008
• Lead Sponsor: McMaster University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-03
• Study Start: 2023-11-06
• Study First Submitted QC: 2023-11-13
• Last Update Submitted: 2023-11-13
• Study First Posted: 2023-11-14
• Last Update Posted: 2023-11-14
• Primary Completion: 2024-04-08
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diastology-Guided Management	Diastology	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.
Diastology-Guided Management	Diastology-Guided Diuresis	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.
Usual Care	Diastology	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.
Usual Care	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.

Primary Outcome Measures

Name	Time	Method
Recruitment Rate	12 months (anticipated study duration)	This is calculated as the number of participants enrolled in the study per month.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.