PVF in Decongestion of Heart Failure

Heart Failure,Congestive Clinical Trial

Official title:

Dynamic Changes in Portal Vein Flow in Decongestion of Patients With Heart Failure and Cardio-Renal Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05227872
• Other study ID #: DCPVFDPHF
• Status: Recruiting
• Start date: October 30, 2021
• Est. completion date: December 2024

Study information

• Verified date: January 2022
• Source: Assiut University
• Contact: Mohamed S Hassanien, Res
• Phone: +201156625520
• Email: mhmdsh94.inv[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Evaluate PVF alterations in patients with ADHF at arrival and after decongestive treatment

Description:

Hospitalizations from heart failure have been shown to be preceded by a gradual increase in cardiac filling pressures using invasive ambulatory monitoring measurements [1, 2]., this technique does not directly assess congestion. The use of point-of-care ultrasound (POCUS) to evaluate lung congestion has been shown to decrease decompensations and urgent heart failure visits [3, 4]. However, besides lung congestion, the abdominal compartment contributes significantly to deranged cardiac as well as renal function in congestive heart failure (CHF) [5].There is increasing recognition that worsening renal function in CHF is related to altered renal blood flow [6, 7]. Recently, alterations in renal venous flow (IRVF) assessed by Doppler imaging have been associated with worse outcomes in patients with CHF [8, 9]. Besides IRVF alterations, portal vein flow (PVF) alterations have been proposed as a marker of venous congestion and right ventricular dysfunction [10, 11]. PVF and IRVF alterations have been shown to correlate with each other and were independently associated with the development of subsequent acute kidney injury (AKI) in patients undergoing cardiac surgery [12, 13]. Portal vein (PV) Doppler is easily obtainable and less time consuming than intra renal venous Doppler. Given the potential usefulness of evaluating venous congestion via POCUS of PVF, we decided to study the dynamic changes that occur during decongestion in patients presenting with heart failure to the emergency department Optimal method for noninvasive assessment of venous congestion remains an unresolved issue. Portal vein (PV) and intra renal venous flow alterations are markers of abdominal venous congestion and have been associated with acute kidney injury (AKI) in cardiac surgery patients. It is currently unknown if portal vein flow (PVF) alterations in heart failure can be reversed with diuretic treatment and track decongestion

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age above 18 years.

2. Patients presented with acute decompensated heart failure (either de novo HF or chronic decompensated HF) fulfilling the following criteria: new or worsening HF symptoms (including dyspnea, decreased exercise capacity, fatigue, or other volume overload symptoms), physical examination findings compatible with HF (peripheral edema, pulmonary congestion, increased jugular venous pressure or third heart sound)

Exclusion Criteria:

1. age below 18.

2. pregnant.

3. cardiogenic shock, or hemodynamic instability.

4. Patients with previously diagnosed Child-Pugh B or C liver cirrhosis, liver transplant, or ESRD on renal replacement therapy

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure,Congestive

Intervention

Device:
• ultrasound
POCUS

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (13)

Abu-Saleh N, Aronson D, Khamaisi M, Khoury EE, Awad H, Kabala A, Ramadan R, Karram T, Kakiashvili E, Bishara B, Abassi Z. Increased Intra-abdominal Pressure Induces Acute Kidney Injury in an Experimental Model of Congestive Heart Failure. J Card Fail. 2019 Jun;25(6):468-478. doi: 10.1016/j.cardfail.2019.03.008. Epub 2019 Mar 14. — View Citation

Araiza-Garaygordobil D, Gopar-Nieto R, Martinez-Amezcua P, Cabello-López A, Alanis-Estrada G, Luna-Herbert A, González-Pacheco H, Paredes-Paucar CP, Sierra-Lara MD, Briseño-De la Cruz JL, Rodriguez-Zanella H, Martinez-Rios MA, Arias-Mendoza A. A randomized controlled trial of lung ultrasound-guided therapy in heart failure (CLUSTER-HF study). Am Heart J. 2020 Sep;227:31-39. doi: 10.1016/j.ahj.2020.06.003. Epub 2020 Jun 15. — View Citation

Arrigo M, Jessup M, Mullens W, Reza N, Shah AM, Sliwa K, Mebazaa A. Acute heart failure. Nat Rev Dis Primers. 2020 Mar 5;6(1):16. doi: 10.1038/s41572-020-0151-7. Review. — View Citation

Beaubien-Souligny W, Benkreira A, Robillard P, Bouabdallaoui N, Chassé M, Desjardins G, Lamarche Y, White M, Bouchard J, Denault A. Alterations in Portal Vein Flow and Intrarenal Venous Flow Are Associated With Acute Kidney Injury After Cardiac Surgery: A Prospective Observational Cohort Study. J Am Heart Assoc. 2018 Oct 2;7(19):e009961. doi: 10.1161/JAHA.118.009961. — View Citation

Beaubien-Souligny W, Rola P, Haycock K, Bouchard J, Lamarche Y, Spiegel R, Denault AY. Quantifying systemic congestion with Point-Of-Care ultrasound: development of the venous excess ultrasound grading system. Ultrasound J. 2020 Apr 9;12(1):16. doi: 10.1186/s13089-020-00163-w. — View Citation

Eljaiek R, Cavayas YA, Rodrigue E, Desjardins G, Lamarche Y, Toupin F, Denault AY, Beaubien-Souligny W. High postoperative portal venous flow pulsatility indicates right ventricular dysfunction and predicts complications in cardiac surgery patients. Br J Anaesth. 2019 Feb;122(2):206-214. doi: 10.1016/j.bja.2018.09.028. Epub 2018 Nov 28. — View Citation

Ellison DH. Why Are Physicians So Confused about Acute Heart Failure? N Engl J Med. 2019 Dec 12;381(24):2374-2375. doi: 10.1056/NEJMc1913976. — View Citation

Husain-Syed F, Birk HW, Ronco C, Schörmann T, Tello K, Richter MJ, Wilhelm J, Sommer N, Steyerberg E, Bauer P, Walmrath HD, Seeger W, McCullough PA, Gall H, Ghofrani HA. Doppler-Derived Renal Venous Stasis Index in the Prognosis of Right Heart Failure. J Am Heart Assoc. 2019 Nov 5;8(21):e013584. doi: 10.1161/JAHA.119.013584. Epub 2019 Oct 19. — View Citation

Iida N, Seo Y, Sai S, Machino-Ohtsuka T, Yamamoto M, Ishizu T, Kawakami Y, Aonuma K. Clinical Implications of Intrarenal Hemodynamic Evaluation by Doppler Ultrasonography in Heart Failure. JACC Heart Fail. 2016 Aug;4(8):674-82. doi: 10.1016/j.jchf.2016.03.016. Epub 2016 May 11. — View Citation

Mentz RJ, O'Connor CM. Pathophysiology and clinical evaluation of acute heart failure. Nat Rev Cardiol. 2016 Jan;13(1):28-35. doi: 10.1038/nrcardio.2015.134. Epub 2015 Sep 15. Review. — View Citation

Rivas-Lasarte M, Álvarez-García J, Fernández-Martínez J, Maestro A, López-López L, Solé-González E, Pirla MJ, Mesado N, Mirabet S, Fluvià P, Brossa V, Sionis A, Roig E, Cinca J. Lung ultrasound-guided treatment in ambulatory patients with heart failure: a randomized controlled clinical trial (LUS-HF study). Eur J Heart Fail. 2019 Dec;21(12):1605-1613. doi: 10.1002/ejhf.1604. Epub 2019 Oct 31. — View Citation

Singh NG, Kumar KN, Nagaraja PS, Manjunatha N. Portal venous pulsatility fraction, a novel transesophageal echocardiographic marker for right ventricular dysfunction in cardiac surgical patients. Ann Card Anaesth. 2020 Jan-Mar;23(1):39-42. doi: 10.4103/aca.ACA_250_18. — View Citation

Tang WH, Kitai T. Intrarenal Venous Flow: A Window Into the Congestive Kidney Failure Phenotype of Heart Failure? JACC Heart Fail. 2016 Aug;4(8):683-6. doi: 10.1016/j.jchf.2016.05.009. Epub 2016 Jul 6. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Portal vein in mm in patients with acute decmpensated heart failure	determine the portal vein flow alteration in mm in patients with acute decompensated heart failure and in patients with cardio renal syndrome	Baseline
Secondary	Differences in portal vein flow in mm in patients with acute decompensated heart failure and compensated HF in cardiorenal syndrome	Determine the differences between portal vein flow in mm in patients with acute decmpensated heart failure and those with compensated heart failure in patients with cardio renal syndrome	Baseline