Assessing the diagnostic value of portal vein pulsatility index in cardiogenic ascites: a prospective pilot study from a low-resource Ethiopian hospital. PULSATE: Portal ULtrasound for Specific Ascites Test for Etiology

Study on pulsatility index of the portal vein as indicator for cardiac etiology in a low resource setting.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202507716159120

Enrollment

Registered

2025-07-02

Start date

2025-07-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive System Cardiology

Interventions

Portal vein Pulsatility Index measurement

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: >18 years old Ultrasound diagnosis of ascites Longitudinal oblique subcostal or intercostal scan visualization of the main portal vein.

Exclusion criteria

Exclusion criteria: Portal vein thrombosis Arterio-portal shunts Impossible to dermine if the cause of ascites is cardiogenic or non-cardiogenic

Design outcomes

Primary

Measure	Time frame
Accuracy of portal vein PI to distinguish ascites with cardiogenic origin from non-cardiogenic causes (Area Under Curve, Youden index, sensitivity, and specificity). Etiology of ascites will be defined by a team of four Internal Medicine Doctors, blinded to the result of the portal vein PI, according to the Hospitals, Ethiopian National, and International Guidelines after clinical evaluation including medical history, physical examination, echocardiography, abdominal ultrasound, laboratory test -complete blood count, creatinine, urinanalysis.	—

Measure

Time frame

Accuracy of portal vein PI to distinguish ascites with cardiogenic origin from non-cardiogenic causes (Area Under Curve, Youden index, sensitivity, and specificity). Etiology of ascites will be defined by a team of four Internal Medicine Doctors, blinded to the result of the portal vein PI, according to the Hospitals, Ethiopian National, and International Guidelines after clinical evaluation including medical history, physical examination, echocardiography, abdominal ultrasound, laboratory test -complete blood count, creatinine, urinanalysis.

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Secondary

Measure	Time frame
Linear correlation between portal vein PI value and ascites grade in patients with cardiogenic ascites (Spearman correlation);Correlation between portal vein PI and the severity (mild, moderate, or severe) of mitral regurgitation (MR), mitral stenosis (MS), aortic regurgitation (AR), aortic stenosis (AS), diastolic dysfunction (Spearman's correlation). ;Correlation between portal vein PI and the presence of right ventricular dilatation, rapid ventricular response atrial fibrillation, hypertensive cardiomyopathy, and ischemic cardiomyopathy (Mann-Whitney U test). ;Correlation between specific echocardiographic parameters (LVEF, TAPSE, sPAP) and portal vein PI (Spearman's correlation);Comparison of the change in portal vein PI after 3 to 6 days of diuretics therapy between patients with and without overall clinical improvement, within the cardiogenic ascites group. Overall clinical improvement will be defined as the presence of at least one of the following: improvement of dyspnea (defined as a decrease of at least one NYHA class); total body weight loss of at least 1kg over the 3-6 day period (according to daily weight measurement); improvement of O2 saturation (defined as an increase to = 90% if baseline was < 90%); or a noticeable decrease of ascites amount according to repeated clinical and ultrasound evaluation (Mann-Whitney U test).;Improvement of sensitivity and specificity of portal vein PI in distinguishing ascites with cardiogenic origin from other causes by adding IVC diameter, hepatic vein, and/or intraparenchymal renal vein flow pattern.	—

Measure

Time frame

Linear correlation between portal vein PI value and ascites grade in patients with cardiogenic ascites (Spearman correlation);Correlation between portal vein PI and the severity (mild, moderate, or severe) of mitral regurgitation (MR), mitral stenosis (MS), aortic regurgitation (AR), aortic stenosis (AS), diastolic dysfunction (Spearman's correlation). ;Correlation between portal vein PI and the presence of right ventricular dilatation, rapid ventricular response atrial fibrillation, hypertensive cardiomyopathy, and ischemic cardiomyopathy (Mann-Whitney U test). ;Correlation between specific echocardiographic parameters (LVEF, TAPSE, sPAP) and portal vein PI (Spearman's correlation);Comparison of the change in portal vein PI after 3 to 6 days of diuretics therapy between patients with and without overall clinical improvement, within the cardiogenic ascites group. Overall clinical improvement will be defined as the presence of at least one of the following: improvement of dyspnea (defined as a decrease of at least one NYHA class); total body weight loss of at least 1kg over the 3-6 day period (according to daily weight measurement); improvement of O2 saturation (defined as an increase to = 90% if baseline was < 90%); or a noticeable decrease of ascites amount according to repeated clinical and ultrasound evaluation (Mann-Whitney U test).;Improvement of sensitivity and specificity of portal vein PI in distinguishing ascites with cardiogenic origin from other causes by adding IVC diameter, hepatic vein, and/or intraparenchymal renal vein flow pattern.

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Countries

Ethiopia

Contacts

Public ContactFlavio Bobbio

Medical Director

f.bobbio@cuamm.org+393356221106

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026