NCT05227872

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

October 30, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 8, 2022

Status Verified

January 1, 2022

Enrollment Period

3 years

First QC Date

October 29, 2021

Last Update Submit

January 22, 2022

Conditions

Heart Failure，Congestive

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Differences in portal vein flow in mm in patients with acute decompensated heart failure and compensated HF in cardiorenal syndrome

    Baseline

Study Arms (2)

Decompensated HF

Device: ultrasound

Compensated HF

Device: ultrasound

Interventions

ultrasoundDEVICE

POCUS

Compensated HFDecompensated HF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cross-sectonal

You may qualify if:

  • Age above 18 years.
  • 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)

You may not qualify if:

  • age below 18.
  • pregnant.
  • cardiogenic shock, or hemodynamic instability.
  • Patients with previously diagnosed Child-Pugh B or C liver cirrhosis, liver transplant, or ESRD on renal replacement therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

RECRUITING

Related Publications (13)

  • 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. No abstract available.

    PMID: 31826353BACKGROUND

  • 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.

    PMID: 32139695BACKGROUND

  • Rivas-Lasarte M, Alvarez-Garcia J, Fernandez-Martinez J, Maestro A, Lopez-Lopez L, Sole-Gonzalez E, Pirla MJ, Mesado N, Mirabet S, Fluvia 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.

    PMID: 31667987BACKGROUND

  • Araiza-Garaygordobil D, Gopar-Nieto R, Martinez-Amezcua P, Cabello-Lopez A, Alanis-Estrada G, Luna-Herbert A, Gonzalez-Pacheco H, Paredes-Paucar CP, Sierra-Lara MD, Briseno-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.

    PMID: 32668323BACKGROUND

  • 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.

    PMID: 30880249BACKGROUND

  • 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.

    PMID: 26370473BACKGROUND

  • 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. No abstract available.

    PMID: 27395345BACKGROUND

  • 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.

    PMID: 27179835BACKGROUND

  • Husain-Syed F, Birk HW, Ronco C, Schormann 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.

    PMID: 31630601BACKGROUND

  • 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.

    PMID: 30686306BACKGROUND

  • 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.

    PMID: 31929245BACKGROUND

  • Beaubien-Souligny W, Benkreira A, Robillard P, Bouabdallaoui N, Chasse 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.

    PMID: 30371304BACKGROUND

  • 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.

    PMID: 32270297BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Mohamed S Hassanien, Res

CONTACT

+201156625520mhmdsh94.inv@gmail.com

Mohamed AlYammany, professor

CONTACT

+201002228914Yamany1@yahoo.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 29, 2021

First Posted

February 8, 2022

Study Start

October 30, 2021

Primary Completion

November 1, 2024

Study Completion

December 1, 2024

Last Updated

February 8, 2022

Record last verified: 2022-01

Locations

EG(1)