Diastology-Guided Management of Decompensated Heart Failure (DYNAMIC)

McMaster University

Status: Not yet enrolling

Conditions: Diastolic Dysfunction; Heart Failure

Treatments: Behavioral: Usual Care; Behavioral: Diastology-Guided Diuresis; Diagnostic Test: Diastology

Study type: Interventional

Funder types: Other

Identifiers

NCT06131008

15276

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

30 participants in 2 patient groups

Diastology-Guided Management

Experimental group

Description:

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.

Treatment:

Behavioral: Diastology-Guided Diuresis

Diagnostic Test: Diastology

Usual Care

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Diastology

Behavioral: Usual Care