Pulmonary HypertensionNCT04947384
Pulmonary Vascular Hemodynamics Before and After Mitral Valve Procedures
An observational study of Pulmonary Hypertension, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The objective of this proposal is to study circulating and echocardiographic markers of pulmonary vascular and right ventricular remodeling in patients with a WHO-2 diagnosis of pulmonary hypertension after mitral valve procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- To discern micro-RNA specific for right and left heart induced PH
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2021to 20 Jan 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing mitral valve procedures at the University of Alabama at Birmingham main hospital
Who may be able to join
- >= 18 years/old
Who cannot join
- Patients with ejection fraction (EF) < 35%
- Patients with severe tricuspid valve regurgitation
- Transplant patients
- Patients scheduled for ventricular assist devices
- Patients with a diagnosis of heart failure with preserved ejection fraction
- Any aortic valvular disease
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
The objective of this proposal is to study circulating and echocardiographic markers of pulmonary vascular and right ventricular remodeling in patients with a WHO-2 diagnosis of pulmonary hypertension after mitral valve procedures. The investigators are proposing the study will be impactful for the early detection and prediction and of residual pulmonary hypertension (PH) that would otherwise be undetected and fatal with no curative treatment.
Read the detailed description
The investigators will enroll 3 groups: Group 1: Patients with established WHO-2 diagnosis of PH undergoing open and interventional mitral valve procedures. Group 2: Patients with no PH undergoing open and interventional mitral valve procedures. Group 3: Patients with established diagnosis of WHO-1-4 groups of PH undergoing right heart catheterization. Groups 2 and 3 will serve as controls. All procedures will be performed at the main UAB Hospital cardiac surgical operating rooms and at the cardiac angiographic suites. The investigators will collect a total of 3 blood samples; the first sample will be obtained on arterial cannulation before the initiation of the intervention, the second sample will be collected upon the end of the procedure prior to leaving the procedure room, and the third sample will be collected on the day of discharge from the hospital. A comprehensive echocardiogram at the 3 corresponding time points of the blood samples obtained; before, and after the intervention and before discharge.
- Conditions
- Pulmonary Hypertension
- Being tested
- To discern micro-RNA specific for right and left heart induced PH
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To discern micro-RNA specific for right and left heart induced PHDiagnostic test
While undergoing other procedures, the investigators will be collecting a total of three blood samples. The first sample will be obtained on arterial cannulation before the initiation of the intervention, the second sample will be collected upon the end of the procedure prior to leaving the procedure room, and the third sample will be collected on the day of discharge from the hospital.
| Study group | Role | What they receive |
|---|---|---|
| Patients with moderate mitral valve disease, undergoing interventions | Patients with established WHO-2 diagnosis of PH undergoing open and interventional mitral valve procedures. Receives: Diagnostic Test: To discern micro-RNA specific for right and left heart induced PH | |
| Patients undergoing mitral valve interventions without pulmonary hypertension | Patients with no PH undergoing open and interventional mitral valve procedures. This group will serve as a control. Receives: Diagnostic Test: To discern micro-RNA specific for right and left heart induced PH | |
| Patients with precapillary pulmonary hypertension scheduled for right heart catheterization | Patients with established diagnosis of WHO-1-4 groups of PH undergoing right heart catheterization. This group will serve as a control. Receives: Diagnostic Test: To discern micro-RNA specific for right and left heart induced PH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker analysis
observation of tissue anomalies in target patients
Measured: From baseline through one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start21 Dec 2021
- Primary completion20 Dec 2025 (estimated)
- Study completion20 Jan 2026 (estimated)
Why it stopped: PI moved to a different institution. Low enrollment rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Zaky, University of Alabama at Birmingham
- Investigators
- Ahmed Zaky, MD, Principal investigator, The University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947384
- Sponsor's protocol ID
- IRB-300006686
- Other IDs
- UAB
- Status last verified
- Jan 2026
- First submitted
- 18 May 2021
- Last updated
- 27 Jan 2026
- 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 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Vascular Hemodynamics Before and After Mitral Valve Procedures
- ClinicalTrials.gov ID
- NCT04947384
- Acronym / sponsor ID
- IRB-300006686
- Conditions
- Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI moved to a different institution. Low enrollment rate.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 20 Jan 2026 (estimated)
- First posted
- 1 Jul 2021 (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 this proposal is to study circulating and echocardiographic markers of pulmonary vascular and right ventricular remodeling in patients with a WHO-2 diagnosis of pulmonary hypertension after mitral valve procedures. The investigators are proposing the study will be impactful for the early detection and prediction and of residual pulmonary hypertension (PH) that would otherwise be undetected and fatal with no curative treatment.
Detailed description
The investigators will enroll 3 groups: Group 1: Patients with established WHO-2 diagnosis of PH undergoing open and interventional mitral valve procedures. Group 2: Patients with no PH undergoing open and interventional mitral valve procedures. Group 3: Patients with established diagnosis of WHO-1-4 groups of PH undergoing right heart catheterization. Groups 2 and 3 will serve as controls. All procedures will be performed at the main UAB Hospital cardiac surgical operating rooms and at the cardiac angiographic suites. The investigators will collect a total of 3 blood samples; the first sample will be obtained on arterial cannulation before the initiation of the intervention, the second sample will be collected upon the end of the procedure prior to leaving the procedure room, and the third sample will be collected on the day of discharge from the hospital. A comprehensive echocardiogram at the 3 corresponding time points of the blood samples obtained; before, and after the intervention and before discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with moderate mitral valve disease, undergoing interventions | – | Diagnostic Test: To discern micro-RNA specific for right and left heart induced PHPatients with established WHO-2 diagnosis of PH undergoing open and interventional mitral valve procedures. |
| Patients undergoing mitral valve interventions without pulmonary hypertension | – | Diagnostic Test: To discern micro-RNA specific for right and left heart induced PHPatients with no PH undergoing open and interventional mitral valve procedures. This group will serve as a control. |
| Patients with precapillary pulmonary hypertension scheduled for right heart catheterization | – | Diagnostic Test: To discern micro-RNA specific for right and left heart induced PHPatients with established diagnosis of WHO-1-4 groups of PH undergoing right heart catheterization. This group will serve as a control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing mitral valve procedures at the University of Alabama at Birmingham main hospital
Key inclusion criteria (1 listed)
- >= 18 years/old
Key exclusion criteria (6 listed)
- Patients with ejection fraction (EF) < 35%
- Patients with severe tricuspid valve regurgitation
- Transplant patients
- Patients scheduled for ventricular assist devices
- Patients with a diagnosis of heart failure with preserved ejection fraction
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 |
|---|---|---|
| To discern micro-RNA specific for right and left heart induced PHWhile undergoing other procedures, the investigators will be collecting a total of three blood samples. The first sample will be obtained on arterial cannulation before the initiation of the intervention, the second sample will be collected upon the end of the procedure prior to leaving the procedure room, and the third sample will be collected on the day of discharge from the hospital. | Diagnostic test | Patients undergoing mitral valve interventions without pulmonary hypertension, Patients with moderate mitral valve disease, undergoing interventions, Patients with precapillary pulmonary hypertension scheduled for right heart catheterization |
Primary outcome
Biomarker analysis
Time frame: From baseline through one year
observation of tissue anomalies in target patients
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 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.
Ahmed Zaky, MD principal investigator
The University of Alabama at Birmingham
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 Pulmonary Hypertension, run by University of Alabama at Birmingham at 1 site in United States.
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 1 inclusion and 6 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: withdrawn, as of the sponsor's last update on 27 Jan 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Biomarker analysis (time frame: From baseline through one year). 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 27 Jan 2026.