Diastology-Guided Management of Decompensated Heart Failure

Heart Failure Clinical Trial

— DYNAMIC  

Official title:

DiastologY-Guided MaNAgement of DecoMpensated Heart Failure: A Pilot RandomIzed, Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06131008
• Other study ID #: 15276
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 6, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: November 2023
• Source: McMaster University
• Contact: Kevin J Um, MD
• Phone: 905-521-2100
• Email: kevin.um[@]dataparty.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 31, 2024
• Est. primary completion date: April 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diastolic Dysfunction
• Heart Failure

Intervention

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

Behavioral:
• 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.
• Usual Care
Clinicians will rely on usual care metrics and parameters to guide diuresis.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rate	This is calculated as the number of participants enrolled in the study per month.	12 months (anticipated study duration)
Secondary	Compliance with Echocardiograms	This is calculated as the number of echocardiograms completed divided by the number scheduled as per the study protocol.	12 months (anticipated study duration)
Secondary	Interpretability of Echocardiograms	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)
Secondary	Adherence to Protocol Recommendations	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)
Secondary	Follow-Up at 30 and 90 Days	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)