Hypertension, PulmonaryNCT02305550
A Proof of Concept Study of Electrical Discharge Produced Nitric Oxide for Inhalation
A study testing electrical pulsed plasma discharge synthesis of nitric oxide in people with Hypertension, Pulmonary, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Study Design: This is a two-part physiological for a device feasibility. Both studies are proof of concept descriptive pilot studies. The FIRST PART is a study of healthy volunteers and the SECOND PART of patients with pulmonary hypertension at routine cardiac catheterization laboratory (CATH-LABORATORY). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- electrical pulsed plasma discharge synthesis of nitric oxide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Jan 2016
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have a government photo identity card;
- Age < 40 years old;
- Body mass index (BMI) <28 kg/m2 and >18 kg/m2;
- Feel well the day of nitric oxide testing;
- Normal physical exam
- Have a government photo identity card;
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- Diagnosis of Pulmonary Arterial Hypertension, Group I, III, IV and V, as defined by the National Heart Lung and Blood Institute classification.
- Known positive responder to inhaled nitric oxide
- Wedge pressure ≤15 mmHg at baseline
- Pulmonary arterial pressure (mean) greater than or equal to 40 mmHg
- Scheduled Cath Lab testing for right heart catheterization to assess pulmonary vasodilator capacity
Who cannot join
- Psychiatric disturbances such as anxiety, depression, schizophrenia requiring pharmacological treatment or hospitalization in the last year;
- Systemic disease with or without any functional limitation; including controlled hypertension and controlled diabetes without systemic effects;
- Pregnancy determined by urine pregnancy test, detecting presence of human chorionic gonadotropin, or less than six weeks postpartum;
- Active smoking, volunteers may be enrolled if they quit smoking for more than 1 year;
- Excess alcohol use: more than ½ L/day of wine consumption or equivalent;
- Any current use of a medication other than: Over-the-counter oral medications, herbal remedies, nutritional supplements, and oral contraceptives;
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- Currently enrolled in another research study.
- SECOND PART OF THE STUDY: CATH-LABORATORY STUDY (n=6 cath laboratory subjects)
- Psychiatric disturbances such as anxiety, depression, schizophrenia requiring pharmacological treatment or hospitalization in the last year;
- Pregnancy determined by urine pregnancy test, detecting presence of human chorionic gonadotropin, or less than six weeks postpartum;
- Left ventricular failure for which breathing nitric oxide is contraindicated;
- Patients with diagnosis of congenital or acquired methemoglobinemia reductase deficiency;
- Currently enrolled in another research study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Study Design: This is a two-part physiological for a device feasibility. Both studies are proof of concept descriptive pilot studies.
The FIRST PART is a study of healthy volunteers and the SECOND PART of patients with pulmonary hypertension at routine cardiac catheterization laboratory (CATH-LABORATORY).
Volunteers and patients will be enrolled sequentially; there is no group randomization.
Overall hypothesis of this device feasibility study: To test a lightweight and portable method of synthesizing therapeutic levels of inhaled nitric oxide from air by electrical pulsed discharge.
Read the detailed description
Background. Inhaled nitric oxide is routinely used to treat acute pulmonary hypertension in infants, children and adults. By 2014 it has been estimate about 500,000 US patients have been treated with nitric oxide, with only the rare complication of methemoglobinemia reported at high inhaled doses.
Rationale. The investigators explored novel alternative lightweight and economical methods of local nitric oxide production. In particular the investigators synthesized nitric oxide from air by an electrical pulsed plasma discharge. After 2 years of study the investigators have designed and produced a prototype of a device synthesizing nitric oxide from air with low levels of nitrogen dioxide and ozone. After completing experimentation in lambs, the investigators now plan to study nitric oxide generators in a proof of concept clinical study.
Design of the study: The study is comprised of two parts:
- HEALTHY volunteer study, and
- CATH-LABORATORY study in patients.
The study will be conducted at low levels of breathing nitric oxide, 25 parts per million of nitric oxide, for 20 minutes to comply with the threshold of the Environmental Protection Agency (EPA) for daily work exposure.
The first portion of the study will be carried out in 6 healthy volunteers breathing 25 parts per million of nitric oxide. After this first part, the investigators will proceed to the second portion of the study and enroll 6 patients with pulmonary hypertension undergoing scheduled testing with a nitric oxide-pulmonary vasodilator response (CATH-LABORATORY study).
- Conditions
- Hypertension, Pulmonary
- Being tested
- electrical pulsed plasma discharge synthesis of nitric oxide
- Keywords
- Nitric Oxide
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical pulsed plasma discharge synthesis of nitric oxideDevice
An NO generator was designed and developed by electrical pulsed plasma discharge nitric oxide from atmospheric nitrogen and oxygen. This generator has been fabricated by the investigators and it is not commercially available.
| Study group | Role | What they receive |
|---|---|---|
| electrical synthesis nitric oxide | Experimental | Participants will breath 20 minutes of electrical pulsed plasma discharge synthesis of nitric oxide at 25 parts per million Receives: Device: electrical pulsed plasma discharge synthesis of nitric oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation
Percent change in oxygen saturation (HbO2/totHb)
Measured: 20 minutes
Methemoglobin
Percent change in methemoglobin levels (metHb/totHb)
Measured: 20 minutes
Carboxyhemoglobin
Percent change in carboxyhemoglobin levels (COHb/totHb)
Measured: 20 minutes
Secondary outcomes (2)
Pulmonary artery pressure
Change in pulmonary artery pressure (mmHg)
Measured: 20 minutes
Cyclic guanosine monophosphate
Percent change in plasma cyclic guanosine monophosphate (measured over baseline)
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startApr 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenzo Berra, MD, Massachusetts General Hospital
- Investigators
- Lorenzo Berra, MD, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305550
- Sponsor's protocol ID
- eNO for inhalation
- Status last verified
- Feb 2017
- First submitted
- 21 Nov 2014
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Malhotra R, Hess D, Lewis GD, Bloch KD, Waxman AB, Semigran MJ. Vasoreactivity to inhaled nitric oxide with oxygen predicts long-term survival in pulmonary arterial hypertension. Pulm Circ. 2011 Apr;1(2):250-258. doi: 10.4103/2045-8932.83449.
PubMed 22020367Frostell C, Fratacci MD, Wain JC, Jones R, Zapol WM. Inhaled nitric oxide. A selective pulmonary vasodilator reversing hypoxic pulmonary vasoconstriction. Circulation. 1991 Jun;83(6):2038-47. doi: 10.1161/01.cir.83.6.2038.
PubMed 2040056
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Study of Electrical Discharge Produced Nitric Oxide for Inhalation
- ClinicalTrials.gov ID
- NCT02305550
- Acronym / sponsor ID
- eNO for inhalation
- Conditions
- Hypertension, Pulmonary
- Keywords
- Nitric Oxide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 2 Dec 2014 (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.
Study Design: This is a two-part physiological for a device feasibility. Both studies are proof of concept descriptive pilot studies.
The FIRST PART is a study of healthy volunteers and the SECOND PART of patients with pulmonary hypertension at routine cardiac catheterization laboratory (CATH-LABORATORY).
Volunteers and patients will be enrolled sequentially; there is no group randomization.
Overall hypothesis of this device feasibility study: To test a lightweight and portable method of synthesizing therapeutic levels of inhaled nitric oxide from air by electrical pulsed discharge.
Detailed description
Background. Inhaled nitric oxide is routinely used to treat acute pulmonary hypertension in infants, children and adults. By 2014 it has been estimate about 500,000 US patients have been treated with nitric oxide, with only the rare complication of methemoglobinemia reported at high inhaled doses.
Rationale. The investigators explored novel alternative lightweight and economical methods of local nitric oxide production. In particular the investigators synthesized nitric oxide from air by an electrical pulsed plasma discharge. After 2 years of study the investigators have designed and produced a prototype of a device synthesizing nitric oxide from air with low levels of nitrogen dioxide and ozone. After completing experimentation in lambs, the investigators now plan to study nitric oxide generators in a proof of concept clinical study.
Design of the study: The study is comprised of two parts:
- HEALTHY volunteer study, and
- CATH-LABORATORY study in patients.
The study will be conducted at low levels of breathing nitric oxide, 25 parts per million of nitric oxide, for 20 minutes to comply with the threshold of the Environmental Protection Agency (EPA) for daily work exposure.
The first portion of the study will be carried out in 6 healthy volunteers breathing 25 parts per million of nitric oxide. After this first part, the investigators will proceed to the second portion of the study and enroll 6 patients with pulmonary hypertension undergoing scheduled testing with a nitric oxide-pulmonary vasodilator response (CATH-LABORATORY study).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| electrical synthesis nitric oxide | Experimental | Device: electrical pulsed plasma discharge synthesis of nitric oxideParticipants will breath 20 minutes of electrical pulsed plasma discharge synthesis of nitric oxide at 25 parts per million |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Have a government photo identity card;
- Age < 40 years old;
- Body mass index (BMI) <28 kg/m2 and >18 kg/m2;
- Feel well the day of nitric oxide testing;
- Normal physical exam
Key exclusion criteria (13 listed)
- Psychiatric disturbances such as anxiety, depression, schizophrenia requiring pharmacological treatment or hospitalization in the last year;
- Systemic disease with or without any functional limitation; including controlled hypertension and controlled diabetes without systemic effects;
- Pregnancy determined by urine pregnancy test, detecting presence of human chorionic gonadotropin, or less than six weeks postpartum;
- Active smoking, volunteers may be enrolled if they quit smoking for more than 1 year;
- Excess alcohol use: more than ½ L/day of wine consumption or equivalent;
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 |
|---|---|---|
| electrical pulsed plasma discharge synthesis of nitric oxideAn NO generator was designed and developed by electrical pulsed plasma discharge nitric oxide from atmospheric nitrogen and oxygen. This generator has been fabricated by the investigators and it is not commercially available. | Device | electrical synthesis nitric oxide |
Primary outcome
Oxygenation
Time frame: 20 minutes
Percent change in oxygen saturation (HbO2/totHb)
Methemoglobin
Time frame: 20 minutes
Percent change in methemoglobin levels (metHb/totHb)
Carboxyhemoglobin
Time frame: 20 minutes
Percent change in carboxyhemoglobin levels (COHb/totHb)
2 secondary outcomes
Pulmonary artery pressure
Time frame: 20 minutes
Cyclic guanosine monophosphate
Time frame: 20 minutes
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 10 Feb 2017.
- Background: PubMed 22020367Malhotra R, Hess D, Lewis GD, Bloch KD, Waxman AB, Semigran MJ. Vasoreactivity to inhaled nitric oxide with oxygen predicts long-term survival in pulmonary arterial hypertension. Pulm Circ. 2011 Apr;1(2):250-258. doi: 10.4103/2045-8932.83449.
- Background: PubMed 2040056Frostell C, Fratacci MD, Wain JC, Jones R, Zapol WM. Inhaled nitric oxide. A selective pulmonary vasodilator reversing hypoxic pulmonary vasoconstriction. Circulation. 1991 Jun;83(6):2038-47. doi: 10.1161/01.cir.83.6.2038.
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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.
Lorenzo Berra, MD principal investigator
MGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrical pulsed plasma discharge synthesis of nitric oxide in people with Hypertension, Pulmonary, run by Massachusetts General Hospital 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 11 inclusion and 13 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 10 Feb 2017. 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 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?
Oxygenation (time frame: 20 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02305550, which also lists 2 linked publications.
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 10 Feb 2017.