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RecruitingNCT06887140Updated May 27, 2026

Prognostic Value of Right Ventricular-pulmonary Arterial Coupling Assessed by Echocardiography in Septic Patients

An observational study in Sepsis, sponsored by University Medical Center Ho Chi Minh City (UMC). Recruiting at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.

Sponsored by University Medical Center Ho Chi Minh City (UMC) · Observational

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
215
Ages
18 Years and older
Sex
All
01

Study summary

Sepsis and septic shock are common clinical conditions, representing a significant healthcare challenge due to their high mortality rates and increasing incidence. Sepsis-induced cardiomyopathy is a frequent complication, occurring in up to 44% of septic patients. This condition is associated with a two- to three-fold increase in mortality. Although sepsis-induced cardiomyopathy is typically diagnosed via echocardiography to assess left ventricular systolic function, both ventricles may be affected. Several studies have demonstrated that right ventricular dysfunction (RVD)/ right ventricular failure (RVF) was prevalent in sepsis and septic shock, with significant implications for prognosis and mortality.

The right ventricle (RV) has a distinct anatomical structure and function compared to the left ventricle, characterized by its high sensitivity to afterload variations. Even minor increases in afterload can severely impair RV contractile function. Meanwhile, septic patients often experience hypoxemic respiratory failure and require mechanical ventilation. This condition generates hypoxia-induced pulmonary vasoconstriction, which, combined with positive pressure ventilation, leads to increased pulmonary vascular resistance and elevated pulmonary arterial pressure. Additionally, systemic vasodilation reduces RV preload, while septic shock and vasopressor use further compromise right coronary perfusion, exacerbating RV contractile dysfunction. Consequently, simultaneous assessment of RV contractility and its afterload is crucial in septic patients.

Tricuspid annular plane systolic excursion (TAPSE) is a widely used echocardiographic parameter for evaluating RV systolic function. Pulmonary artery systolic pressure (sPAP) reflects RV afterload and can be estimated in the presence of tricuspid regurgitation. Recently, the TAPSE/sPAP ratio has been proposed as a clinical tool to assess right ventricle-pulmonary artery (RV-PA) coupling. This index has been shown to be associated with mortality in patients with pulmonary hypertension and heart failure. Several studies have been conducted to evaluate RV-PA coupling in sepsis and septic shocks, but these studies have limitations in terms of study design and patient selection.

In Vietnam, the issues of RVD/RVF in sepsis/septic shock have not been thoroughly investigated. Le Minh Khoi and colleagues reported that the incidence of reduced RV strain in septic patients was as high as 55.1%. Currently, no studies have specifically evaluated RV function, nor have any studies assessed RV-PA coupling in septic patients.

02

Conditions studied

  • Sepsis

Keywords

  • Sepsis
  • Septic shock
  • Sepsis-induced Cardiomyopathy
  • Right ventricle-pulmonary artery coupling
  • Echocardiography
03

In context

Sepsis

2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.

This study's planned enrollment of 215 is above the median of 150 across 1,162 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

University Medical Center Ho Chi Minh City (UMC) is the lead sponsor of 34 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients received treatment in the Intensive Care Unit (ICU) at the University Medical Center at Ho Chi Minh City during the study period

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosed with sepsis,
  • Received treatment in the Intensive Care Unit (ICU) at the University Medical Center at Ho Chi Minh City during the study period.

Exclusion criteria

Exclusion Criteria:

  • Pregnancy,
  • History of right ventricular myocardial infarction,
  • Acute coronary syndrome within the past 1 week,
  • Valvular heart diseases or a history of valve replacement surgery,
  • Congenital heart diseases or conditions involving intracardiac shunts.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
215 participants (estimated)
Patient registry
No

Groups and cohorts

  • Septic patients not having right ventricle-pulmonary artery uncoupling

    Diagnostic Test: Echocardiography

  • Septic patients having right ventricle-pulmonary artery uncoupling

    Diagnostic Test: Echocardiography

Interventions

  • Diagnostic testEchocardiography

    * First echocardiography: within 24 hours after study enrollment, * Second echocardiography: 48-72 hours after the initial echocardiography. * The recorded echocardiographic parameters include: * Morphological and Functional Parameters * Mitral Valve Flow Parameters * Tissue Doppler Echocardiography Parameters * STE Parameters for Left Ventricle Assessment * STE Parameters for Right Ventricle Assessment

06

What researchers measure

Primary outcomes

  1. In-hospital mortality

    Time frame: Feb 2027

Secondary outcomes

  1. Duration of mechanical ventilation

    Time frame: Feb 2027

  2. Length of stay in Intensive Care Unit

    Time frame: Feb 2027

  3. Length of stay in hospital

    Time frame: Feb 2027

  4. Mortality in Intensive Care Unit

    Time frame: Feb 2027

07

Study locations

1 of 1 sites recruiting
  • University Medical Center
    Ho Chi Minh City, 700000, Vietnam
    Recruiting
08

References and documents

Publications

  • Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C, Machado FR, Reinhart KK, Rowan K, Seymour CW, Watson RS, West TE, Marinho F, Hay SI, Lozano R, Lopez AD, Angus DC, Murray CJL, Naghavi M. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020 Jan 18;395(10219):200-211. doi: 10.1016/S0140-6736(19)32989-7. PubMed 31954465 ↗
  • Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287. PubMed 26903338 ↗
  • Ehrman RR, Sullivan AN, Favot MJ, Sherwin RL, Reynolds CA, Abidov A, Levy PD. Pathophysiology, echocardiographic evaluation, biomarker findings, and prognostic implications of septic cardiomyopathy: a review of the literature. Crit Care. 2018 May 4;22(1):112. doi: 10.1186/s13054-018-2043-8. PubMed 29724231 ↗
  • Konstam MA, Kiernan MS, Bernstein D, Bozkurt B, Jacob M, Kapur NK, Kociol RD, Lewis EF, Mehra MR, Pagani FD, Raval AN, Ward C; American Heart Association Council on Clinical Cardiology; Council on Cardiovascular Disease in the Young; and Council on Cardiovascular Surgery and Anesthesia. Evaluation and Management of Right-Sided Heart Failure: A Scientific Statement From the American Heart Association. Circulation. 2018 May 15;137(20):e578-e622. doi: 10.1161/CIR.0000000000000560. Epub 2018 Apr 12. PubMed 29650544 ↗
  • Mikkelsen ME, Shah CV, Meyer NJ, Gaieski DF, Lyon S, Miltiades AN, Goyal M, Fuchs BD, Bellamy SL, Christie JD. The epidemiology of acute respiratory distress syndrome in patients presenting to the emergency department with severe sepsis. Shock. 2013 Nov;40(5):375-81. doi: 10.1097/SHK.0b013e3182a64682. PubMed 23903852 ↗
  • Wang S, Bashir Z, Chen EW, Kadiyala V, Sherrod CF, Has P, Song C, Ventetuolo CE, Simmons J, Haines P. Invasive Mechanical Ventilation Is Associated with Worse Right Ventricular Strain in Acute Respiratory Failure Patients. J Cardiovasc Dev Dis. 2024 Aug 9;11(8):246. doi: 10.3390/jcdd11080246. PubMed 39195154 ↗
  • Repesse X, Charron C, Vieillard-Baron A. Acute respiratory distress syndrome: the heart side of the moon. Curr Opin Crit Care. 2016 Feb;22(1):38-44. doi: 10.1097/MCC.0000000000000267. PubMed 26627538 ↗
  • Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available. PubMed 20620859 ↗
  • Guazzi M, Naeije R. Pulmonary Hypertension in Heart Failure: Pathophysiology, Pathobiology, and Emerging Clinical Perspectives. J Am Coll Cardiol. 2017 Apr 4;69(13):1718-1734. doi: 10.1016/j.jacc.2017.01.051. PubMed 28359519 ↗
  • Jentzer JC, Anavekar NS, Reddy YNV, Murphree DH, Wiley BM, Oh JK, Borlaug BA. Right Ventricular Pulmonary Artery Coupling and Mortality in Cardiac Intensive Care Unit Patients. J Am Heart Assoc. 2021 Apr 6;10(7):e019015. doi: 10.1161/JAHA.120.019015. Epub 2021 Mar 28. PubMed 33775107 ↗
  • Charpentier J, Luyt CE, Fulla Y, Vinsonneau C, Cariou A, Grabar S, Dhainaut JF, Mira JP, Chiche JD. Brain natriuretic peptide: A marker of myocardial dysfunction and prognosis during severe sepsis. Crit Care Med. 2004 Mar;32(3):660-5. doi: 10.1097/01.ccm.0000114827.93410.d8. PubMed 15090944 ↗
  • Vallabhajosyula S, Kumar M, Pandompatam G, Sakhuja A, Kashyap R, Kashani K, Gajic O, Geske JB, Jentzer JC. Prognostic impact of isolated right ventricular dysfunction in sepsis and septic shock: an 8-year historical cohort study. Ann Intensive Care. 2017 Sep 7;7(1):94. doi: 10.1186/s13613-017-0319-9. PubMed 28884343 ↗
  • Vieillard-Baron A, Prigent A, Repesse X, Goudelin M, Prat G, Evrard B, Charron C, Vignon P, Geri G. Right ventricular failure in septic shock: characterization, incidence and impact on fluid responsiveness. Crit Care. 2020 Nov 1;24(1):630. doi: 10.1186/s13054-020-03345-z. PubMed 33131508 ↗
  • Lanspa MJ, Cirulis MM, Wiley BM, Olsen TD, Wilson EL, Beesley SJ, Brown SM, Hirshberg EL, Grissom CK. Right Ventricular Dysfunction in Early Sepsis and Septic Shock. Chest. 2021 Mar;159(3):1055-1063. doi: 10.1016/j.chest.2020.09.274. Epub 2020 Oct 14. PubMed 33068615 ↗
  • Guazzi M, Bandera F, Pelissero G, Castelvecchio S, Menicanti L, Ghio S, Temporelli PL, Arena R. Tricuspid annular plane systolic excursion and pulmonary arterial systolic pressure relationship in heart failure: an index of right ventricular contractile function and prognosis. Am J Physiol Heart Circ Physiol. 2013 Nov 1;305(9):H1373-81. doi: 10.1152/ajpheart.00157.2013. Epub 2013 Aug 30. PubMed 23997100 ↗
  • Zhang H, Lian H, Zhang Q, Chen X, Wang X, Liu D. Prognostic implications of tricuspid annular plane systolic excursion/pulmonary arterial systolic pressure ratio in septic shock patients. Cardiovasc Ultrasound. 2020 Jun 12;18(1):20. doi: 10.1186/s12947-020-00198-y. PubMed 32532300 ↗
  • Bowcock EM, Gerhardy B, Huang S, Orde S. Right ventricular outflow tract Doppler flow analysis and pulmonary arterial coupling by transthoracic echocardiography in sepsis: a retrospective exploratory study. Crit Care. 2022 Oct 3;26(1):303. doi: 10.1186/s13054-022-04160-4. PubMed 36192793 ↗
  • Ma Q, Ding C, Wei W, Su C, Li B, Zhou Z, Chen C, Liu B, Zhang X, Wu J. The value of right ventricular pulmonary artery coupling in determining the prognosis of patients with sepsis. Sci Rep. 2024 Jul 3;14(1):15283. doi: 10.1038/s41598-024-65738-2. PubMed 38961249 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2025 (actual). Primary completion is estimated for Feb 2027, 22 months after the start.

Of 491 non-industry observational studies under Sepsis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 58. This study's planned 22 months is below that.

Counting every sponsor, half of 543 studies reached it within 27 months; a quarter within 12 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 14, 2025
First posted
Mar 20, 2025
StartActual
Apr 16, 2025
Primary completionEst.
Feb 2027
CompletionEst.
Feb 2027
Last update
May 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06887140
Lead sponsor
University Medical Center Ho Chi Minh City (UMC)
Responsible party
Sponsor
First posted
Mar 20, 2025
Start date
Apr 16, 2025
Primary completion
Feb 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
May 27, 2026

Study contacts

Anh-Minh V Phan, MSc.
Contact
minh.pva@umc.edu.vn
+84907216232
Khoi M Le, A/Prof. Dr.
Contact
khoi.lm@umc.edu.vn
+84919731386
Khoi M Le, A/Prof. Dr.
study chair · University Medical Center Ho Chi Minh City

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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