Diastology-Guided Management of Decompensated Heart Failure

NCT06131008 | Unknown DMC

• 1 other identifier: 15276
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure; Diastolic Dysfunction

Keywords

diastology; echocardiography; heart failure

Outcome Measures

Primary Outcomes (1)

• Recruitment Rate

  This is calculated as the number of participants enrolled in the study per month.

  12 months (anticipated study duration)

Secondary Outcomes (4)

• Compliance with Echocardiograms

  12 months (anticipated study duration)

• Interpretability of Echocardiograms

  12 months (anticipated study duration)

• Adherence to Protocol Recommendations

  12 months (anticipated study duration)

• Follow-Up at 30 and 90 Days

  12 months (anticipated study duration)

Study Arms (2)

Diastology-Guided Management

EXPERIMENTAL

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; Behavioral: Diastology-Guided Diuresis

Usual Care

ACTIVE COMPARATOR

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; Behavioral: Usual Care

Interventions

Diastology DIAGNOSTIC_TEST

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

Diastology-Guided Management; Usual Care

Diastology-Guided Diuresis 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.

Diastology-Guided Management

Usual Care BEHAVIORAL

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

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Related Publications (6)

• Khan MS, Sreenivasan J, Lateef N, Abougergi MS, Greene SJ, Ahmad T, Anker SD, Fonarow GC, Butler J. Trends in 30- and 90-Day Readmission Rates for Heart Failure. Circ Heart Fail. 2021 Apr;14(4):e008335. doi: 10.1161/CIRCHEARTFAILURE.121.008335. Epub 2021 Apr 19.

  PMID: 33866827 BACKGROUND

• Van Spall HGC, Lee SF, Xie F, Oz UE, Perez R, Mitoff PR, Maingi M, Tjandrawidjaja MC, Heffernan M, Zia MI, Porepa L, Panju M, Thabane L, Graham ID, Haynes RB, Haughton D, Simek KD, Ko DT, Connolly SJ. Effect of Patient-Centered Transitional Care Services on Clinical Outcomes in Patients Hospitalized for Heart Failure: The PACT-HF Randomized Clinical Trial. JAMA. 2019 Feb 26;321(8):753-761. doi: 10.1001/jama.2019.0710.

  PMID: 30806695 BACKGROUND

• Felker GM, Anstrom KJ, Adams KF, Ezekowitz JA, Fiuzat M, Houston-Miller N, Januzzi JL Jr, Mark DB, Pina IL, Passmore G, Whellan DJ, Yang H, Cooper LS, Leifer ES, Desvigne-Nickens P, O'Connor CM. Effect of Natriuretic Peptide-Guided Therapy on Hospitalization or Cardiovascular Mortality in High-Risk Patients With Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial. JAMA. 2017 Aug 22;318(8):713-720. doi: 10.1001/jama.2017.10565.

  PMID: 28829876 BACKGROUND

• Abraham WT, Adamson PB, Bourge RC, Aaron MF, Costanzo MR, Stevenson LW, Strickland W, Neelagaru S, Raval N, Krueger S, Weiner S, Shavelle D, Jeffries B, Yadav JS; CHAMPION Trial Study Group. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet. 2011 Feb 19;377(9766):658-66. doi: 10.1016/S0140-6736(11)60101-3.

  PMID: 21315441 BACKGROUND

• Nagueh SF, Smiseth OA, Appleton CP, Byrd BF 3rd, Dokainish H, Edvardsen T, Flachskampf FA, Gillebert TC, Klein AL, Lancellotti P, Marino P, Oh JK, Popescu BA, Waggoner AD. Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2016 Apr;29(4):277-314. doi: 10.1016/j.echo.2016.01.011. No abstract available.

  PMID: 27037982 BACKGROUND

• Abraham WT, Stevenson LW, Bourge RC, Lindenfeld JA, Bauman JG, Adamson PB; CHAMPION Trial Study Group. Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: complete follow-up results from the CHAMPION randomised trial. Lancet. 2016 Jan 30;387(10017):453-61. doi: 10.1016/S0140-6736(15)00723-0. Epub 2015 Nov 9.

  PMID: 26560249 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Kevin J Um, MD

CONTACT

905-521-2100; kevin.um@dataparty.ca

Emilie P Belley-Cote, MD PhD

CONTACT

905-521-2100; emilie.belley-cote@phri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 14, 2023
• Study Start: November 6, 2023
• Primary Completion: April 8, 2024
• Study Completion: July 31, 2024
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share