PVF in Decongestion of Heart Failure

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05227872
Collaborator
(none)
30
1
37.1
0.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: ultrasound

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

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Dynamic Changes in Portal Vein Flow in Decongestion of Patients With Heart Failure and Cardio-Renal Syndrome
Actual Study Start Date :
Oct 30, 2021
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Decompensated HF

Device: ultrasound
POCUS

Compensated HF

Device: ultrasound
POCUS

Outcome Measures

Primary Outcome Measures

  1. Portal vein in mm in patients with acute decmpensated heart failure [Baseline]

    determine the portal vein flow alteration in mm in patients with acute decompensated heart failure and in patients with cardio renal syndrome

Secondary Outcome Measures

  1. Differences in portal vein flow in mm in patients with acute decompensated heart failure and compensated HF in cardiorenal syndrome [Baseline]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut University Assiut Egypt

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mohamed Salah, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05227872
Other Study ID Numbers:
  • DCPVFDPHF
First Posted:
Feb 8, 2022
Last Update Posted:
Feb 8, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2022