PVF in Decongestion of Heart Failure

NCT ID: NCT05227872

Last Updated: 2022-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-30

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure,Congestive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Decompensated HF

ultrasound

Intervention Type DEVICE

POCUS

Compensated HF

ultrasound

Intervention Type DEVICE

POCUS

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ultrasound

POCUS

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohamed Salah

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Assiut University

Asyut, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mohamed S Hassanien, Res

Role: CONTACT

+201156625520

Mohamed AlYammany, professor

Role: CONTACT

+201002228914

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mohamed S Hassanien, Res

Role: primary

+201156625520

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 31826353 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32139695 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31667987 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32668323 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30880249 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26370473 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27395345 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27179835 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31630601 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30686306 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31929245 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30371304 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32270297 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DCPVFDPHF

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.