Clinical trial NCT06131008: Diastology-Guided Management of Decompensated Heart Failure
Official title: DiastologY-Guided MaNAgement of DecoMpensated Heart Failure: A Pilot RandomIzed, Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure
Diastolic Dysfunction
Keywords: diastology
echocardiography
heart failure
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment Rate
timeFrame: 12 months (anticipated study duration)
Secondary outcomes:
measure: Compliance with Echocardiograms
timeFrame: 12 months (anticipated study duration)
measure: Interpretability of Echocardiograms
timeFrame: 12 months (anticipated study duration)
measure: Adherence to Protocol Recommendations
timeFrame: 12 months (anticipated study duration)
measure: Follow-Up at 30 and 90 Days
timeFrame: 12 months (anticipated study duration)
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.
citation: 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.
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.
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.