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Completed

NCT Number: NCT07512310

Non-Invasive and Invasive Assessment of Heart Filling Pressure

This study evaluates how different non-invasive and invasive measurements reflect left ventricular filling pressure, an important indicator of cardiac function. Elevated filling pressure is associated with symptoms such as shortness of breath and plays a central role in the diagnosis and management of heart failure and pulmonary hypertension.

In clinical practice, filling pressure can be estimated using echocardiography or measured during cardiac catheterisation. However, the relationships between these measurements and their ability to accurately reflect true filling pressure are not fully understood.

This retrospective study includes patients who underwent cardiac catheterisation with invasive haemodynamic assessment and temporally related echocardiographic evaluation as part of routine clinical care. The aim is to improve understanding of how different measurements relate to each other and to identify which parameters best reflect elevated filling pressure.

The results are expected to support more accurate interpretation of haemodynamic measurements and improve clinical decision-making, particularly regarding the use of non-invasive versus invasive assessment.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

West German Heart and Vascular Centre Essen, University Hospital Essen

Essen, Germany

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (≥18 years)
  • Clinically indicated left- and right-heart catheterisation under resting conditions
  • Availability of invasive left ventricular end-diastolic pressure (LVEDP) measurement
  • Availability of pulmonary capillary wedge pressure (PCWP) measurement
  • Availability of transthoracic echocardiography within 5 days of cardiac catheterisation
  • Adequate echocardiographic image quality for analysis

Exclusion criteria

  • Missing or incomplete invasive haemodynamic measurements (LVEDP or PCWP)
  • Missing or non-interpretable echocardiographic data
  • Haemodynamic instability at the time of measurement
  • Incomplete data required for analysis

Treatment and study plan

Primary outcomes

  1. Accuracy of non-invasive and invasive parameters for identifying elevated left ventricular filling pressure

    Time frame: At the time of cardiac catheterisation (baseline)

    Assessment of the ability of non-invasive and invasive surrogate parameters to identify elevated left ventricular filling pressure, with simultaneously obtained invasive left ventricular end-diastolic pressure serving as the reference standard

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Registry information

Official study title

NIPRESS: Non-Invasive and Invasive Pressure Evaluation and Stratification Study

Acronym: NIPRESS

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Apr 6, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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