Pulmonary HypertensionPhase 1/2PROCLAIMNCT02886793
Cell Proliferation in Pulmonary Hypertension. FDG-PET Comparison Between Patients and Healthy Subjects
A Phase 1/2 study testing fludeoxyglucose in people with Pulmonary Hypertension, run by Joan Albert Barbera Mir.
Trial summary
Pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) are serious diseases with poor prognosis despite recent advances. Currently, pulmonary hypertension (PH) is considered a cell proliferative disorder, which has not been adequately characterized due to the lack of markers. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- fludeoxyglucose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Aug 2018
- Phase
- Phase 1/2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with PAH:
- Hemodynamic diagnosis of precapillary pulmonary hypertension: PAPm ≥25 mmHg, PCWP ≤15 mmHg
Who cannot join
- Patients with CTEPH:
- Hemodynamic diagnosis of precapillary pulmonary hypertension: PAPm ≥25 mmHg, PCWP ≤15 mmHg
- Persistence of thrombotic perfusion defects on pulmonary scintigraphy or angioCT, after 3 months or more of correct anticoagulant therapy
- Healthy subjects
- No known disease or condition
- Normal lung function, chest x-ray, EKG and blood chemistry and haematology
Show all 12Show fewer
- Severe comorbidity.
- Pulmonary, pleural or rib cage disease interfering with FDG-PET acquisition
- Malignancy with exception of basocellular carcinoma
- Current smoker or former smoker (last 10 years or more than 10-year-pack).
- Pregnant or lactating women Hyperglycemia (fasting above 200 mg/dL)
- Hypersensitivity to the product or its excipients
About this study
Pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) are serious diseases with poor prognosis despite recent advances. Currently, pulmonary hypertension (PH) is considered a cell proliferative disorder, which has not been adequately characterized due to the lack of markers. A better understanding of the mechanisms that regulate this proliferative disorder will allow the identification of new therapeutic targets for HP.
The objective of the project is to identify cell proliferative processes in severe forms of PH. Patients with PAH (n=20), CTEPH (n=20) and healthy controls (n=20) will undergo characterization of microRNAs (miRNAs) contained within circulating microparticles (MPs) analysis and mitochondrial functionality and FDG-PET to compare cell metabolism in the lungs and the right ventricle between patients and controls.
- Conditions
- Pulmonary Hypertension
- Being tested
- fludeoxyglucose
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fludeoxyglucoseDrug
Also called FDG
| Study group | Role | What they receive |
|---|---|---|
| FDG | Experimental | all patients will undergo a PET scan and will receive 18F fludeoxyglucose Receives: Drug: fludeoxyglucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
FDG uptake in lung parenchyma
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startJun 2016
- Primary completionJul 2018
- Study completionAug 2018
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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joan Albert Barbera Mir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joan Albert Barbera Mir, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886793
- Sponsor's protocol ID
- 2016-000347-14
- Other IDs
- 2016
- Acronym
- PROCLAIM
- Status last verified
- Sep 2019
- First submitted
- 29 Aug 2016
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell Proliferation in Pulmonary Hypertension. FDG-PET Comparison Between Patients and Healthy Subjects
- ClinicalTrials.gov ID
- NCT02886793
- Acronym / sponsor ID
- PROCLAIM / 2016-000347-14
- Conditions
- Pulmonary Hypertension
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Joan Albert Barbera MirUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 1 Sep 2016 (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.
Pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) are serious diseases with poor prognosis despite recent advances. Currently, pulmonary hypertension (PH) is considered a cell proliferative disorder, which has not been adequately characterized due to the lack of markers. A better understanding of the mechanisms that regulate this proliferative disorder will allow the identification of new therapeutic targets for HP.
The objective of the project is to identify cell proliferative processes in severe forms of PH. Patients with PAH (n=20), CTEPH (n=20) and healthy controls (n=20) will undergo characterization of microRNAs (miRNAs) contained within circulating microparticles (MPs) analysis and mitochondrial functionality and FDG-PET to compare cell metabolism in the lungs and the right ventricle between patients and controls.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FDG | Experimental | Drug: fludeoxyglucoseall patients will undergo a PET scan and will receive 18F fludeoxyglucose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with PAH:
Key exclusion criteria (12 listed)
- Patients with CTEPH:
- Healthy subjects
- Severe comorbidity.
- Pulmonary, pleural or rib cage disease interfering with FDG-PET acquisition
- Malignancy with exception of basocellular carcinoma
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 |
|---|---|---|
| fludeoxyglucoseAlso: FDG | Drug | FDG |
Primary outcome
FDG uptake in lung parenchyma
Time frame: 1 hour
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 18 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing fludeoxyglucose in people with Pulmonary Hypertension, run by Joan Albert Barbera Mir.
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 2 inclusion and 12 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 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
FDG uptake in lung parenchyma (time frame: 1 hour). 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 18 Sep 2019.