Pulmonary Hypertension (PH) Due to Left Heart DiseaseTROPHY-IINCT03611270
TReatment of Pulmonary Hypertension Group II Study
A study testing Pulmonary Denervation in people with Pulmonary Hypertension (PH) Due to Left Heart Disease, run by SoniVie Inc. at 3 sites in United States.
Trial summary
The objective of this study is to assess the safety and initial effectiveness of the TIVUS™ System when used for pulmonary artery denervation in group II PH patients through change in clinical parameters including hemodynamics, exercise tolerance, and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension (PH) Due to Left Heart Disease
- What is being tested?
- Pulmonary Denervation
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Nov 2018to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Written informed consent to participate in the study obtained from the patient, according to local regulations, prior to initiation of any study mandated procedure.
- Male or female, ≥ 18 years of age at the time of screening
- Patient with known pulmonary hypertension (PH) due to left heart disease (WHO Group II) diagnosed as either HFpEF or HFrEF at chronic state receiving stable guideline directed medical therapy.
- Combined post-capillary and precapillary pulmonary hypertension diagnosis confirmed by hemodynamic evaluation performed prior to screening or during baseline (Eligibility II visit) procedure
- Patient with a current diagnosis of NYHA functional class II/III
- Patient with eGFR levels of ≥ 30 ml/min/1.73m2or serum creatinine levels of ˂ 150μmol/l
Who cannot join
- Pregnant women or women planning a pregnancy within 12 months of study enrolment
- Patient with significant co-morbid condition(s) which, at the discretion of the PI, are deemed to prohibit study entry
- Patient with life expectancy of less than a year
- Concurrent enrollment in another device or drug trial except for observational studies (unless specifically approved by the sponsor)
- Patient with pulmonary artery anatomy that precludes treatment
- Patient with moderate to severe pulmonary artery stenosis
Show all 10Show fewer
- Patient with any pulmonary artery aneurysm
- Patient who has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 6 months
- Patient experiencing a current episode of acute decompensated heart failure
- Patient who has cardiac pacemakers/ICD/CRT-D that were implanted fewer than three months prior to enrolment. Patient who has implantable Cardiomems device, neurostimulators or drug infusion devices, regardless of implant date.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114-2696
UC San Diego Medical Center
San Diego, California, 92037
University of California, San Francisco Medical Center
San Francisco, California, 94158
About this study
Official title: Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Pulmonary Artery Denervation in Patients With Pulmonary Hypertension Due to Left Heart Disease
The objective of this study is to assess the safety and initial effectiveness of the TIVUS™ System when used for pulmonary artery denervation in group II PH patients through change in clinical parameters including hemodynamics, exercise tolerance, and quality of life.
This is a prospective, multi-center, non-randomized, open-label clinical trail. The study will be conducted in up to 3 centers and will recruit up to 15 patients diagnosed with pulmonary hypertension due to left heart disease that demonstrate combined pre and post capillary involvement with PVR>3 wood units.
- Being tested
- Pulmonary Denervation
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary DenervationDevice
Pulmonary Denervation (PDN) using the TIVUS™ System will be performed in patient suffering from pulmonary hypertension after completion of screening and eligibility phase, The procedure will be performed during right heart catheterisation. Safety and effectiveness of the PDN treatment will be assessed during one year follow up.
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural related Adverse Events (complications) at up to 30 days post procedure
Procedural related Adverse Events (complications) at up to 30 days post procedure including pulmonary artery perforation/dissection, acute thrombus formation in the pulmonary artery, pulmonary artery aneurysm, vascular stenosis, hemoptysis, all cause PH related as well as procedural related death.
Measured: 30 days
Secondary outcomes (13)
Changes in cardiopulmonary exercise test
Changes in cardiopulmonary exercise test (CPET) results (Peak VO2, VE/VCO2 slope, VO2 at anaerobic threshold, peak workload) from baseline
Measured: 4 month
Change in resting mean right atrial pressure
Change in resting mean atrial pressure (mRAP) from baseline
Measured: 4 month
Changes in 6MWD from baseline
Changes in 6MWD from baseline
Measured: 4 month
Changes in Echocardiography parameters
Changes in Echocardiography parameters including Right Ventricular function from baseline
Measured: 4 month
Change in NT-BNP levels
Change in NT-BNP levels from baseline
Measured: 4 month
Procedure related and PH worsening adverse events
Procedure related and PH worsening adverse events and all cause death up to 12 months will be recorded, and serious adverse events will be reported in accordance with regulatory requirements.
Measured: 12 month
Change in exercise mean right atrial pressure
Change in exercise mean right atrial pressure (mRAP) from baseline
Measured: 4 month
Change in exercise mean pulmonary artery pressure
Change in exercise mean pulmonary artery pressure (mPAP) from baseline
Measured: 4 month
Change in exercise pulmonary vascular resistance
Change in exercise pulmonary vascular resistance (PVR) from baseline
Measured: 4 month
Change in exercise cardiac index
Change in exercise cardiac index (CI) from baseline
Measured: 4 month
Change in resting mean pulmonary artery pressure
Change in resting mean pulmonary artery pressure (mPAP) from baseline
Measured: 4 month
Change in resting pulmonary vascular resistance
Change in resting pulmonary vascular resistance (PVR) from baseline
Measured: 4 month
Change in resting cardiac index
Change in resting cardiac index (CI) from baseline
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start30 Nov 2018
- Primary completion1 Dec 2023 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Hypertension (PH) Due to Left Heart DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SoniVie Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611270
- Sponsor's protocol ID
- CLNS02-001
- Acronym
- TROPHY-II
- Status last verified
- Aug 2023
- First submitted
- 20 Jun 2018
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Pulmonary Artery Denervation in Patients With Pulmonary Hypertension Due to Left Heart Disease
- ClinicalTrials.gov ID
- NCT03611270
- Acronym / sponsor ID
- TROPHY-II / CLNS02-001
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- SoniVie Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 2 Aug 2018 (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 study is to assess the safety and initial effectiveness of the TIVUS™ System when used for pulmonary artery denervation in group II PH patients through change in clinical parameters including hemodynamics, exercise tolerance, and quality of life.
This is a prospective, multi-center, non-randomized, open-label clinical trail. The study will be conducted in up to 3 centers and will recruit up to 15 patients diagnosed with pulmonary hypertension due to left heart disease that demonstrate combined pre and post capillary involvement with PVR>3 wood units.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent to participate in the study obtained from the patient, according to local regulations, prior to initiation of any study mandated procedure.
- Male or female, ≥ 18 years of age at the time of screening
- Patient with known pulmonary hypertension (PH) due to left heart disease (WHO Group II) diagnosed as either HFpEF or HFrEF at chronic state receiving stable guideline directed medical therapy.
- Combined post-capillary and precapillary pulmonary hypertension diagnosis confirmed by hemodynamic evaluation performed prior to screening or during baseline (Eligibility II visit) procedure
- Patient with a current diagnosis of NYHA functional class II/III
Key exclusion criteria (10 listed)
- Pregnant women or women planning a pregnancy within 12 months of study enrolment
- Patient with significant co-morbid condition(s) which, at the discretion of the PI, are deemed to prohibit study entry
- Patient with life expectancy of less than a year
- Concurrent enrollment in another device or drug trial except for observational studies (unless specifically approved by the sponsor)
- Patient with pulmonary artery anatomy that precludes treatment
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 |
|---|---|---|
| Pulmonary DenervationPulmonary Denervation (PDN) using the TIVUS™ System will be performed in patient suffering from pulmonary hypertension after completion of screening and eligibility phase, The procedure will be performed during right heart catheterisation. Safety and effectiveness of the PDN treatment will be assessed during one year follow up. | Device | – |
Primary outcome
Procedural related Adverse Events (complications) at up to 30 days post procedure
Time frame: 30 days
Procedural related Adverse Events (complications) at up to 30 days post procedure including pulmonary artery perforation/dissection, acute thrombus formation in the pulmonary artery, pulmonary artery aneurysm, vascular stenosis, hemoptysis, all cause PH related as well as procedural related death.
13 secondary outcomes
Changes in cardiopulmonary exercise test
Time frame: 4 month
Change in resting mean right atrial pressure
Time frame: 4 month
Changes in 6MWD from baseline
Time frame: 4 month
Changes in Echocardiography parameters
Time frame: 4 month
Change in NT-BNP levels
Time frame: 4 month
Procedure related and PH worsening adverse events
Time frame: 12 month
Change in exercise mean right atrial pressure
Time frame: 4 month
Change in exercise mean pulmonary artery pressure
Time frame: 4 month
Change in exercise pulmonary vascular resistance
Time frame: 4 month
Change in exercise cardiac index
Time frame: 4 month
Change in resting mean pulmonary artery pressure
Time frame: 4 month
Change in resting pulmonary vascular resistance
Time frame: 4 month
Change in resting cardiac index
Time frame: 4 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Denervation in people with Pulmonary Hypertension (PH) Due to Left Heart Disease, run by SoniVie Inc. at 3 sites 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 6 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Procedural related Adverse Events (complications) at up to 30 days post procedure (time frame: 30 days). 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 21 Aug 2023.