Pulmonary HypertensionPhase 1NCT02374229
Ablation of the Pulmonary Artery With High Pulmonary Hypertension During Mitral Valve Surgery
A Phase 1 study testing Surgical ablation of ganglion plexus pulmonary artery. and mitral valve surgery in people with Pulmonary Hypertension, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
The aim of this prospective randomized study was to evaluate the effectiveness and safety of the original ablation procedures ganglion plexus pulmonary artery with simultaneous correction of valvular heart disease, complicated by high pulmonary hypertension. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Surgical ablation of ganglion plexus pulmonary artery. and mitral valve surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- Feb 2015to Nov 2016
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with mitral stenosis or insufficiency complicated by high pulmonary hypertension (mean pulmonary artery pressure in invasive monitoring more than 35 mm Hg), which are subject to surgical treatment.
Who cannot join
- pulmonary stenosis;
- pulmonary embolism in history;
- congenital heart disease.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Novosibirsk State Research Institute of Circulation Pathology
Novosibirsk, Novosibirsk Oblast, 630055
Alexander V Bogachev-Prokophiev, MD PhD, +79137539546, bogachev.prokophiev@gmail.com
Denis P Demidov, +79231935938, demidoff85@mail.ru
About this study
Official title: Surgical Ablation of Ganglion Plexuses of the Pulmonary Artery in Patients With Valvular Heart Disease, Complicated by High Pulmonary Hypertension May Reduce Its Degree.
The aim of this prospective randomized study was to evaluate the effectiveness and safety of the original ablation procedures ganglion plexus pulmonary artery with simultaneous correction of valvular heart disease, complicated by high pulmonary hypertension.
Read the detailed description
Pulmonary hypertension is a serious condition, the severity of which is often underestimated. About 10% of significant mitral heart disease complicated by high pulmonary hypertension (more than 60 mm Hg). Up to 70% of patients retain this level of pulmonary hypertension after successful treatment of heart valve disease.The quality of life of patients with persistent high pulmonary hypertension is significantly lower than in patients with mild to moderate degree. Risks of recurrent tricuspid insufficiency and right ventricular dysfunction is much higher. Despite the use of modern drug therapy of pulmonary hypertension in patients with valvular heart disease satisfactory clinical effect is achieved only in a small number of patients. Our team proposed a new original method of ablation of the pulmonary artery with simultaneous open cardiac surgery correction of mitral heart disease in patients with high baseline pulmonary hypertension.
- Conditions
- Pulmonary Hypertension
- Being tested
- Surgical ablation of ganglion plexus pulmonary artery., mitral valve surgery
- Keywords
- pulmonary hypertension, pulmonary artery denervation, mitral valve disease
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical ablation of ganglion plexus pulmonary artery.Procedure or surgery
Also called surgical ablation, radiofrequency ablation
Performed ablation zone pulmonary artery bifurcation, at 2mm proximal direction and a distal direction in the left and right branches of the pulmonary artery using the electrophysiological device Atricure.
mitral valve surgeryProcedure or surgery
Also called mitral valve repair, mitral velve replacement
The standard procedure for mitral regurgitation or stenosis, the procedures will be a valve repair or mitral valve replacement, depending upon the particular morphological condition of the mitral valve.
| Study group | Role | What they receive |
|---|---|---|
| The study group | Experimental | Procedure: mitral valve surgery, surgical ablation of ganglion plexus pulmonary artery.
Will include 15 patients with mitral stenosis or insufficiency subject to correction, complicated by high pulmonary hypertension. During the operation, a standard surgical procedure for the treatment of heart valve disease will be complemented by the ablation zone of bifurcation of the pulmonary artery, surgical ablation of ganglion plexus pulmonary artery.
For mitral regurgitation or stenosis, the procedures will be a valve repair or mitral valve replacement.
Procedure will be considered effective in the face of declining average pressure in the pulmonary artery for invasive monitoring of 10mm Hg and more. Receives: Procedure: Surgical ablation of ganglion plexus pulmonary artery.; Procedure: mitral valve surgery |
| The control group | Active comparator | Procedure:mitral valve surgery. Will include 15 patients with mitral stenosis or insufficiency subject to correction, complicated by high pulmonary hypertension. Patients will be made standard procedure correction mitral valve disease without pulmonary artery denervation.
For mitral regurgitation or stenosis, the procedures will be a valve repair or mitral valve replacement only. Receives: Procedure: mitral valve surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death of the patient
Measured: 3 weeks
Secondary outcomes (4)
Mean pulmonary artery pressure in invasive monitoring
Patients will be installed catheter Swan-Ganz in the intensive care unit for invasive measurement of pulmonary artery pressure.
Measured: 3weeks; 6 and 12 months after the procedure.
Exercise tolerance (the 6 minute walk test (6MWD)
the 6 minute walk test (6MWD)
Measured: 3weeks; 6 and 12 months after the procedure.
quality of life
SF-36 questionnaire
Measured: 3weeks; 6 and 12 months after the procedure.
adverse events
complications associated with the procedure plexus ganglion ablation, such as perforation of the pulmonary artery, pulmonary artery dissection, pulmonary embolism.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
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.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Aleksandr V Bogachev-Prokophiev, MD PhD, Principal investigator, Meshalkin Research Institute of Pathology of Circulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374229
- Sponsor's protocol ID
- GAPA 1
- Status last verified
- Sep 2015
- First submitted
- 12 Feb 2015
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Ablation of Ganglion Plexuses of the Pulmonary Artery in Patients With Valvular Heart Disease, Complicated by High Pulmonary Hypertension May Reduce Its Degree.
- ClinicalTrials.gov ID
- NCT02374229
- Acronym / sponsor ID
- GAPA 1
- Conditions
- Pulmonary Hypertension
- Keywords
- pulmonary hypertension, pulmonary artery denervation, mitral valve disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Feb 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 27 Feb 2015 (estimated)
- 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 aim of this prospective randomized study was to evaluate the effectiveness and safety of the original ablation procedures ganglion plexus pulmonary artery with simultaneous correction of valvular heart disease, complicated by high pulmonary hypertension.
Detailed description
Pulmonary hypertension is a serious condition, the severity of which is often underestimated. About 10% of significant mitral heart disease complicated by high pulmonary hypertension (more than 60 mm Hg). Up to 70% of patients retain this level of pulmonary hypertension after successful treatment of heart valve disease.The quality of life of patients with persistent high pulmonary hypertension is significantly lower than in patients with mild to moderate degree. Risks of recurrent tricuspid insufficiency and right ventricular dysfunction is much higher. Despite the use of modern drug therapy of pulmonary hypertension in patients with valvular heart disease satisfactory clinical effect is achieved only in a small number of patients. Our team proposed a new original method of ablation of the pulmonary artery with simultaneous open cardiac surgery correction of mitral heart disease in patients with high baseline pulmonary hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The study group | Experimental | Procedure: Surgical ablation of ganglion plexus pulmonary artery., Procedure: mitral valve surgeryProcedure: mitral valve surgery, surgical ablation of ganglion plexus pulmonary artery. Will include 15 patients with mitral stenosis or insufficiency subject to correction, complicated by high pulmonary hypertension. During the operation, a standard surgical procedure for the treatment of heart valve disease will be complemented by the ablation zone of bifurcation of the pulmonary artery, surgical ablation of ganglion plexus pulmonary artery. For mitral regurgitation or stenosis, the procedures will be a valve repair or mitral valve replacement. Procedure will be considered effective in the face of declining average pressure in the pulmonary artery for invasive monitoring of 10mm Hg and more. |
| The control group | Active comparator | Procedure: mitral valve surgeryProcedure:mitral valve surgery. Will include 15 patients with mitral stenosis or insufficiency subject to correction, complicated by high pulmonary hypertension. Patients will be made standard procedure correction mitral valve disease without pulmonary artery denervation. For mitral regurgitation or stenosis, the procedures will be a valve repair or mitral valve replacement only. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with mitral stenosis or insufficiency complicated by high pulmonary hypertension (mean pulmonary artery pressure in invasive monitoring more than 35 mm Hg), which are subject to surgical treatment.
Key exclusion criteria (3 listed)
- pulmonary stenosis;
- pulmonary embolism in history;
- congenital heart disease.
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 |
|---|---|---|
| Surgical ablation of ganglion plexus pulmonary artery.Also: surgical ablation, radiofrequency ablationPerformed ablation zone pulmonary artery bifurcation, at 2mm proximal direction and a distal direction in the left and right branches of the pulmonary artery using the electrophysiological device Atricure. | Procedure or surgery | The study group |
| mitral valve surgeryAlso: mitral valve repair, mitral velve replacementThe standard procedure for mitral regurgitation or stenosis, the procedures will be a valve repair or mitral valve replacement, depending upon the particular morphological condition of the mitral valve. | Procedure or surgery | The control group, The study group |
Primary outcome
Death of the patient
Time frame: 3 weeks
4 secondary outcomes
Mean pulmonary artery pressure in invasive monitoring
Time frame: 3weeks; 6 and 12 months after the procedure.
Exercise tolerance (the 6 minute walk test (6MWD)
Time frame: 3weeks; 6 and 12 months after the procedure.
quality of life
Time frame: 3weeks; 6 and 12 months after the procedure.
adverse events
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
Related trials for Pulmonary Hypertension
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
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.
Aleksandr V Bogachev-Prokophiev, MD PhD principal investigator
Meshalkin Research Institute of Pathology of Circulation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Surgical ablation of ganglion plexus pulmonary artery. and mitral valve surgery in people with Pulmonary Hypertension, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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 3 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: status not confirmed, as of the sponsor's last update on 23 Sep 2015. 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 Russia. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aleksandr V Bogachev-Prokophiev, MD PhD (+79137539546, bogachev.prokophiev@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death of the patient (time frame: 3 weeks). 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 23 Sep 2015.