Heart FailureNIPRESSNCT07512310
Non-Invasive and Invasive Assessment of Heart Filling Pressure
An observational study of Heart Failure and Pulmonary Hypertension, run by University Hospital, Essen at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Pulmonary Hypertension, Ventricular Dysfunction, Left
- How many people
- 623 participants
- Where
- 1 siteGermany
- Study dates
- 15 Mar 2018to 14 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
West German Heart and Vascular Centre Essen, University Hospital Essen
Essen, Essen
About this study
Official title: 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.
Read more
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.
- Conditions
- Heart Failure, Pulmonary Hypertension, Ventricular Dysfunction, Left, Ventricular Dysfunction
- Medical subject headings
- Heart Failure, Hypertension, Pulmonary, Ventricular Dysfunction, Left, Ventricular Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of non-invasive and invasive parameters for identifying elevated left ventricular filling pressure
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
Measured: At the time of cardiac catheterisation (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start15 Mar 2018
- Primary completion14 Mar 2024
- Study completion14 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 623 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512310
- Sponsor's protocol ID
- NIPRESS-I-24-12114-BO
- Acronym
- NIPRESS
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIPRESS: Non-Invasive and Invasive Pressure Evaluation and Stratification Study
- ClinicalTrials.gov ID
- NCT07512310
- Acronym / sponsor ID
- NIPRESS / NIPRESS-I-24-12114-BO
- Conditions
- Heart Failure, Pulmonary Hypertension, Ventricular Dysfunction, Left, Ventricular Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 623 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Pulmonary Hypertension, run by University Hospital, Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of non-invasive and invasive parameters for identifying elevated left ventricular filling pressure (time frame: At the time of cardiac catheterisation (baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.