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Portal Pressure in Heart Failure PoP-HF: a pilot study

Portal Pressure in Heart Failure PoP-HF: a pilot study - PoP-HF

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57225
Enrollment
30
Registered
2024-12-12
Start date
2024-08-01
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

cardiac failure heart failure

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age >= 18 years - Give written informed consent - Scheduled for right heart catheterization for analysis of heart failure

Exclusion criteria

Exclusion criteria: - Substantiated liver disease or dysfunction including ASAT and/or ALAT > 3x the upper limit of normal (ULN) - Currently requiring dialysis or estimated GFR

Design outcomes

Primary

MeasureTime frame
The primary outcome concerns the portal pressure gradient (HPVG). HVPG represents the difference between the wedged hepatic venous pressure (WHVP) and the free hepatic venous pressure (FHVP). The WHVP is measured by occluding the right hepatic vein through the inflation of a balloon, whereas FHVP is measured without occluding it. The normal HVPG value is between 1 to 5 mmHg. A figure above this range indicates elevated portal pressure. According to their prognostic value, patients with portal hypertension can be classified in two main groups: mild or subclinical (>=6 to 9 mmHg) and clinically significant portal hypertension (>=10 mmHg).

Secondary

MeasureTime frame
- The association between the portal pressure gradient (HPVG) and renal function (eGFR) - The association between HPVG and fecal elastase (FE-1)/presence of exocrine pancreas insufficiency (EPI) - The association between HPVG and other hemodynamic indices (pulmonary capillary wedge pressure (PCWP), right atrial pressure (RAP), pulmonary arterial pressure (PAP) obtained during cardiac catheterization.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)