Non-Invasive and Invasive Assessment of Heart Filling Pressure (NIPRESS)

March 30, 2026 updated by: University Hospital, Essen

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

623

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Essen, Germany, Essen
        • West German Heart and Vascular Centre Essen, University Hospital Essen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Consecutive adult patients undergoing clinically indicated left- and right-heart catheterisation at the West German Heart and Vascular Centre Essen, University Hospital Essen, Germany, with available invasive haemodynamic measurements and echocardiographic assessment as part of routine clinical care.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At the time of cardiac catheterisation (baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Essen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2018

Primary Completion (Actual)

March 14, 2024

Study Completion (Actual)

March 14, 2024

Study Registration Dates

First Submitted

March 30, 2026

First Submitted That Met QC Criteria

March 30, 2026

First Posted (Actual)

April 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIPRESS-I-24-12114-BO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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