Aortic Valve StenosisPREFLOWNCT05580237
Pressure Gradient vs. Flow Relationships in Patients With Symptomatic Valvular Aortic Stenosis
An observational study of Aortic Valve Stenosis, run by Aarhus University Hospital Skejby at 1 site in Denmark.
Trial summary
The objective of the present study is to investigate to hemodynamic profile at rest and during peak exercise of patients with suspected severe aortic stenosis and to compare flow- and pressure changes between high gradient patients and low gradient patients. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Simultaneous right and left heart catheterization
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2019to 1 Dec 2023
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspected severe AS scheduled for evaluation for aortic valve intervention
Who may be able to join
- Patients with suspected severe AS scheduled for evaluation for aortic valve intervention:
- LVEF > 50 %
- AVA < 1.0 cm2
- Symptomatic - at least equivalent to NYHA functional class II
Who cannot join
- Congenital heart disease
- Severe coronary artery disease (main stem, proximal LAD or 3 vessel disease)
- Moderate or severe aortic valve regurgitation
- Moderate or severe mitral valve regurgitation or stenosis
- Moderate or severe pulmonary valve regurgitation or stenosis
- Moderate or severe tricuspid valve regurgitation or stenosis
Show all 11Show fewer
- Severe pulmonary hypertension (tricuspid valve pressure gradient of 60 mmHg)
- Right ventricular dysfunction (TAPSE < 17 mm)
- Restrictive cardiomyopathy or cardiac amyloidosis
- Constrictive pericarditis
- Inability to perform supine bicycle exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pressure Gradient vs. Flow Relationships in Patients With Symptomatic Valvular Aortic Stenosis - a Comparison Between High- and Low Gradient Subtypes
The objective of the present study is to investigate to hemodynamic profile at rest and during peak exercise of patients with suspected severe aortic stenosis and to compare flow- and pressure changes between high gradient patients and low gradient patients.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Simultaneous right and left heart catheterization
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous right and left heart catheterizationProcedure or surgery
Pressure recordings across the aortic valve with simultaneous flow measurements by right heart catheterization, during rest and during supine exercise.
| Study group | Role | What they receive |
|---|---|---|
| Severe aortic valve stenosis | Not described Receives: Procedure: Simultaneous right and left heart catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure and flow relationships across the aortic valve during rest and during supine exercise
Pressure drop across the aortic valve measured invasively. Flow across the valve estimated by right heart catheterization in the absence of aortic valve regurgitation.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start1 Sep 2019
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies 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
- Cross-sectional
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henrik Vase, Aarhus University Hospital Skejby
- Investigators
- Henrik Vase, MD, PhD, Principal investigator, Department of Cardiology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580237
- Sponsor's protocol ID
- 1-10-72-71-19
- Acronym
- PREFLOW
- Status last verified
- Jan 2024
- First submitted
- 10 May 2022
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure Gradient vs. Flow Relationships in Patients With Symptomatic Valvular Aortic Stenosis - a Comparison Between High- and Low Gradient Subtypes
- ClinicalTrials.gov ID
- NCT05580237
- Acronym / sponsor ID
- PREFLOW / 1-10-72-71-19
- Conditions
- Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 14 Oct 2022 (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.
The objective of the present study is to investigate to hemodynamic profile at rest and during peak exercise of patients with suspected severe aortic stenosis and to compare flow- and pressure changes between high gradient patients and low gradient patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe aortic valve stenosis | – | Procedure: Simultaneous right and left heart catheterization |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected severe AS scheduled for evaluation for aortic valve intervention
Key inclusion criteria (4 listed)
- Patients with suspected severe AS scheduled for evaluation for aortic valve intervention:
- LVEF > 50 %
- AVA < 1.0 cm2
- Symptomatic - at least equivalent to NYHA functional class II
Key exclusion criteria (11 listed)
- Congenital heart disease
- Severe coronary artery disease (main stem, proximal LAD or 3 vessel disease)
- Moderate or severe aortic valve regurgitation
- Moderate or severe mitral valve regurgitation or stenosis
- Moderate or severe pulmonary valve regurgitation or stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simultaneous right and left heart catheterizationPressure recordings across the aortic valve with simultaneous flow measurements by right heart catheterization, during rest and during supine exercise. | Procedure or surgery | Severe aortic valve stenosis |
Primary outcome
Pressure and flow relationships across the aortic valve during rest and during supine exercise
Time frame: 2 hours
Pressure drop across the aortic valve measured invasively. Flow across the valve estimated by right heart catheterization in the absence of aortic valve regurgitation.
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 3 Jan 2024.
Related trials for Aortic Valve Stenosis
Recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening
RecruitingObservational study
Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
Severe Aortic Valve Stenosis, Valvular Heart Disease
RecruitingObservational study
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Heart Valve Diseases, Aortic Valve Stenosis
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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.
Henrik Vase, MD, PhD principal investigator
Department of Cardiology, Aarhus University Hospital
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 Aortic Valve Stenosis, run by Aarhus University Hospital Skejby at 1 site in Denmark.
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 4 inclusion and 11 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 3 Jan 2024. 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 Denmark. 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?
Pressure and flow relationships across the aortic valve during rest and during supine exercise (time frame: 2 hours). 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 3 Jan 2024.