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Pulmonary; HypertensionPhase 1PMEDNCT02980068

A Study of Oral Nitrate in Adults With Pulmonary Hypertension With Heart Failure and Preserved Ejection Fraction

A Phase 1 study testing 15N Nitrate and 14N Nitrate in people with Pulmonary; Hypertension and Heart Failure, run by Gladwin, Mark, MD at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label, single-center study to examine distinguishing features of the structure and function of the oral and gut microbiome in healthy adult normal volunteers compared to volunteers with PH-HFpEF in the breakdown of oral nitrate. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
15N Nitrate and 14N Nitrate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
2 sitesUnited States
Study dates
28 Aug 2017to 25 Feb 2022
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female, 18 years of age or older
  • PH group: Pulmonary hypertension, hemodynamically defined by a mean PAP ≥ 25 mm Hg, and a TPG >= 12 at rest or during exercise as demonstrated on a right heart catheterization in the last 10 years
  • RHC Control group: Normal hemodynamics (mean PAP < 25 mm Hg, PCWP ≤ 15 mm Hg) on clinical right heart catheterization
  • Healthy Control group: Healthy patients with no evidence of pulmonary hypertension, respiratory or cardiac disease
  • Ability to provide written informed consent

Who cannot join

  • Use of systemic antibiotics and/or chlorhexidine mouthwash, within the previous three months
  • Use of immune suppression (chemotherapy, oral prednisone greater than 20mg per day, etc) with in the previous three months
  • Use of phosphodiesterase-5 inhibitors (tadalafil, sildenafil, etc) within 7 days before study drug administration
  • Current pregnancy or lactation
  • Uncontrolled systemic hypertension based on repeated measurement of sitting systolic blood pressure >185 mm Hg or sitting diastolic blood pressure >110 mm Hg at screening
  • Has chronic renal insufficiency as defined by serum creatinine >3 mg/dL at screening or requires dialytic support
Show all 15Show fewer
  • Known history of left ventricular ejection fraction < 40% by multiple gated acquisition scan (MUGA), angiography, or echocardiography
  • History of atrial septostomy
  • Repaired or unrepaired congenital heart disease
  • Pericardial constriction
  • Restrictive or constrictive cardiomyopathy
  • Symptomatic coronary disease with demonstrable ischemia
  • Addition or change in dosing of hormonal contraception medications (OCP, IUD, Depo-Provera) in the past 4 weeks.
  • Other severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study or would prevent completion of the study
  • Active participation in other research studies with investigational drugs

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Nydia Chien

    Pittsburgh, Pennsylvania, 15213

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: An Open Label Study of Oral Nitrate in Adults With Pulmonary Hypertension With Heart Failure and Preserved Ejection Fraction (PH-HFpEF) and Normal Healthy Adults

This is an open-label, single-center study to examine distinguishing features of the structure and function of the oral and gut microbiome in healthy adult normal volunteers compared to volunteers with PH-HFpEF in the breakdown of oral nitrate.

Read the detailed description

We will enroll 60 Group II PH (PH-HFpEF) or Group I PAH patients and 60 matched healthy controls over three years. The Subjects will receive a single dose of one of the two study drugs, determined by whether they will participate in one study visit or two: 15N nitrate (1,000 mg) or 14N Sodium Nitrate: standard sodium nitrate, and all will receive one dose of CLA 3g. Twenty of the PH or PAH subjects and 20 of the control subjects willing to return for a follow up visit 24 hours after drug administration will receive 15N nitrate. All others will receive standard sodium nitrate. CLA will be obtained from GNC (General Nutrition Corporation) and given once.

Throughout the experiment, we will measure blood pressure, heart rate, and respiratory rate as well as co-oximetry. Plasma samples are collected at approximate times 0, 2, and 6 hrs post-drug administration. Urine will be collected at approximate times 0 and 6 hrs. We will examine plasma and urine nitrate and nitrite. The 40 subjects who return for a second visit 24 hours post-drug administration will provide an additional plasma and urine sample.

Being tested
15N Nitrate, 14N Nitrate
Medical subject headings
Hypertension, Pulmonary, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 15N NitrateDrug

    Also called 15N Sodium Nitrate

    1,000 mg/11.8 mmol, oral, on day one, hour zero

  • 14N NitrateDrug

    Also called 14N Sodium Nitrate

    1,000 mg/11.18 mmol, oral, on day hour, hour zero

Study groups in NCT02980068
Study groupRoleWhat they receive
15N NitrateExperimentalsingle 1,000mg dose of 15N nitrate with 3g of conjugated linoleic acid (CLA).
Receives: Drug: 15N Nitrate
14N Sodium NitrateExperimentalsingle 1,000mg dose of 14N sodium nitrate with 3g of conjugated linoleic acid (CLA)
Receives: Drug: 14N Nitrate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in nitrate level in urine

    The investigators will examine urine nitrate

    Measured: Urine collected approx 0 & 6 hours after drug administration

  2. Change in nitrate level in plasma

    The investigators will examine plasma nitrate

    Measured: Approx 50cc of blood drawn approx 0, 2, & 6 hours after drug administration

  3. Bacterial content of gut microbiome

    Stool will be analyzed for bacterial makeup

    Measured: Stool collected before drug administration

  4. Bacterial content of the oral microbiome

    Saliva and tongue scraping will be analyzed for bacterial makeup

    Measured: Saliva and tongue scraping will occur preceding administration of drug

  5. Change in nitrite level in urine

    The investigators will examine urine nitrite

    Measured: Urine collected approx 0 & 6 hours after drug administration

  6. Change in nitrite level in plasma

    The investigators will examine plasma nitrite

    Measured: Approx 50cc of blood drawn approx 0, 2, & 6 hours after drug administration

Secondary outcomes (4)

  1. Change in blood pressure

    Measured: Frequently over 6 hour study visit

  2. Change in heart rate

    Measured: Continuous over 6 hour study visit

  3. Change in respiratory rate

    Measured: Continuous over 6 hour study visit

  4. Change in hemoglobin concentration

    Measured: Continuous over 6 hour study visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2016 (estimated)
  2. Study start28 Aug 2017
  3. Primary completion25 Feb 2022
  4. Study completion25 Feb 2022

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02980068
Sponsor's protocol ID
STUDY19120066
Other IDs
5P01HL103455
Acronym
PMED
Status last verified
Mar 2022
First submitted
17 Nov 2016
Last updated
22 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: After de-identification, all participant data collected during the trial will be made available.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 15N Nitrate and 14N Nitrate in people with Pulmonary; Hypertension and Heart Failure, run by Gladwin, Mark, MD at 2 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 5 inclusion and 15 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 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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.

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?

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?

Change in nitrate level in urine (time frame: Urine collected approx 0 & 6 hours after drug administration). The study lists 6 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 NCT02980068.

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 22 Mar 2022.

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