Diastology-Guided Management of Decompensated Heart Failure (DYNAMIC)
November 13, 2023 updated by: Emilie Belley-Cote, McMaster University
DiastologY-Guided MaNAgement of DecoMpensated Heart Failure: A Pilot RandomIzed, Controlled Trial
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kevin J Um, MD
- Phone Number: 40741 905-521-2100
- Email: kevin.um@dataparty.ca
Study Contact Backup
- Name: Emilie P Belley-Cote, MD PhD
- Phone Number: 40741 905-521-2100
- Email: emilie.belley-cote@phri.ca
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
We will follow American Society of Echocardiography criteria to determine the degree of diastolic dysfunction after performing each focused echocardiogram.
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.
|
|
Active Comparator: 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.
|
We will follow American Society of Echocardiography criteria to determine the degree of diastolic dysfunction after performing each focused echocardiogram.
Clinicians will rely on usual care metrics and parameters to guide diuresis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment Rate
Time Frame: 12 months (anticipated study duration)
|
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
Time Frame: 12 months (anticipated study duration)
|
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
Time Frame: 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.
|
12 months (anticipated study duration)
|
|
Adherence to Protocol Recommendations
Time Frame: 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.
|
12 months (anticipated study duration)
|
|
Follow-Up at 30 and 90 Days
Time Frame: 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.
|
12 months (anticipated study duration)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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. Erratum In: Lancet. 2012 Feb 4;379(9814):412.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
November 6, 2023
Primary Completion (Estimated)
April 8, 2024
Study Completion (Estimated)
July 31, 2024
Study Registration Dates
First Submitted
November 3, 2023
First Submitted That Met QC Criteria
November 13, 2023
First Posted (Estimated)
November 14, 2023
Study Record Updates
Last Update Posted (Estimated)
November 14, 2023
Last Update Submitted That Met QC Criteria
November 13, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15276
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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