Heart Failure，CongestiveNCT05227872
PVF in Decongestion of Heart Failure
An observational study of Heart Failure，Congestive, run by Assiut University at 1 site in Egypt.
Trial summary
Evaluate PVF alterations in patients with ADHF at arrival and after decongestive treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure，Congestive
- What is being tested?
- ultrasound
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2021to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cross-sectonal
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut
Mohamed S Hassanien, Res, +201156625520, mhmdsh94.inv@gmail.com
About this study
Official title: Dynamic Changes in Portal Vein Flow in Decongestion of Patients With Heart Failure and Cardio-Renal Syndrome
Evaluate PVF alterations in patients with ADHF at arrival and after decongestive treatment
Read the detailed 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
- Conditions
- Heart Failure，Congestive
- Being tested
- ultrasound
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
POCUS
| Study group | Role | What they receive |
|---|---|---|
| Decompensated HF | Not described Receives: Device: ultrasound | |
| Compensated HF | Not described Receives: Device: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (1)
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start30 Oct 2021
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Heart Failure，CongestiveStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Salah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227872
- Sponsor's protocol ID
- DCPVFDPHF
- Status last verified
- Jan 2022
- First submitted
- 29 Oct 2021
- Last updated
- 8 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31826353Arrigo 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.
PubMed 32139695Rivas-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.
PubMed 31667987Araiza-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.
PubMed 32668323Abu-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.
PubMed 30880249Mentz 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.
PubMed 26370473Tang 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.
PubMed 27395345Iida 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.
PubMed 27179835Husain-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.
PubMed 31630601Eljaiek 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.
PubMed 30686306Singh 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.
PubMed 31929245Beaubien-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.
PubMed 30371304Beaubien-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.
PubMed 32270297
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Changes in Portal Vein Flow in Decongestion of Patients With Heart Failure and Cardio-Renal Syndrome
- ClinicalTrials.gov ID
- NCT05227872
- Acronym / sponsor ID
- DCPVFDPHF
- Conditions
- Heart Failure，Congestive
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Oct 2021 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate PVF alterations in patients with ADHF at arrival and after decongestive treatment
Detailed 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
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decompensated HF | – | Device: ultrasound |
| Compensated HF | – | Device: ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cross-sectonal
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasoundPOCUS | Device | Compensated HF, Decompensated HF |
Primary outcome
Portal vein in mm in patients with acute decmpensated heart failure
Time frame: Baseline
determine the portal vein flow alteration in mm in patients with acute decompensated heart failure and in patients with cardio renal syndrome
1 secondary outcome
Differences in portal vein flow in mm in patients with acute decompensated heart failure and compensated HF in cardiorenal syndrome
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Background: PubMed 31826353Ellison 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.
- Background: PubMed 32139695Arrigo 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.
- Background: PubMed 31667987Rivas-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.
- Background: PubMed 32668323Araiza-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.
- Background: PubMed 30880249Abu-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.
- Background: PubMed 26370473Mentz 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.
- Background: PubMed 27395345Tang 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.
- Background: PubMed 27179835Iida 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.
- Background: PubMed 31630601Husain-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.
- Background: PubMed 30686306Eljaiek 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.
- Background: PubMed 31929245Singh 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.
- Background: PubMed 30371304Beaubien-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure，Congestive, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed S Hassanien, Res (+201156625520, mhmdsh94.inv@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Portal vein in mm in patients with acute decmpensated heart failure (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05227872, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.