Is NCT01730092 recruiting in Bethesda, MD?

Yes, NCT01730092 is currently recruiting participants at its Bethesda, MD location. This pulmonary disease clinical trial is actively enrolling qualified participants.

How do I join the pulmonary disease clinical trial in Bethesda?

To join this clinical trial in Bethesda, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Bethesda clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Pulmonary Disease Clinical Trial in Bethesda, MD

About This Pulmonary Disease Study in Bethesda

Background: \- High blood pressure in the lungs, known as pulmonary arterial hypertension (PAH), is a rare disorder. Some people have disease-associated PAH and some have PAH from an unknown cause. Researchers want to follow the natural history of all PAH patients to understand how PAH progresses in order to discover targets for future research into new treatments. To further identify treatment targets, they will compare healthy volunteers to patients with PAH. Objectives: \- To study the natural history of PAH. Eligibility: * Individuals at least 18 years of age who have PAH. * Healthy volunteers at least 18 years of age. Design: * Participants with PAH will have periodic visits to the National Institutes of Health Clinical Center. After the first visit, they will return in 6 months and then yearly or every other year for as long as the study continues. * The first visit will take up to 3 days. It will involve the following tests: * Physical exam and medical history * Blood and urine samples * Heart and lung function tests and imaging studies * Six-minute walk test * Questions about exercise and physical activity * Healthy volunteers will have only one visit to the Clinical Center, during which they will undergo screening tests, and complete many of the same tests as patients with PAH

Sponsor: National Institutes of Health Clinical Center (CC)

Who Can Participate

Exclusion Criteria

based on race or sex. INCLUSION AND EXCLUSION CRITERIA FOR PAH SUBJECTS: Inclusion Criteria: The following parameters on RHC are required to meet the hemodynamic definition of PAH (NYHA/WHO Group I PH):

mean pulmonary artery pressure of \> 25 mmHg at rest,

pulmonary capillary wedge pressure of \< 15 mmHg (or a left ventricular end-diastolic pressure of \< 12 mmHg), and

pulmonary vascular resistance of \> 3 Wood units (240 dyn s cm-5). For patients with suspected PAH (Group I PH) who have not undergone a RHC and/or additional testing to confirm the diagnosis, this testing will be completed as clinically indicated under a procedural consent. If clinically indicated (diagnostic) testing indicates that the subject with suspected PAH does not in fact meet standard criteria for PAH (Group I PH), then the subject will be removed from the study. Exclusion Criteria:

Pregnant or breastfeeding women (all women of childbearing potential will be required to have a screening urine or blood pregnancy test)

Age less than 18 years

Inability to provide informed written consent for participation in the study INCLUSION AND EXCLUSION CRITERIA FOR HEALTHY CONTROL SUBJECTS: Inclusion Criteria for Control Subjects Any healthy man or woman who is the appropriate age and sex for matching to a PAH patient

Must be eligible for MRI and Gadolinium Based MRI studies

Must be eligible for CT and Iodine Based Contrast CT studies Exclusion Criteria for Healthy Control Subjects

Current pregnancy or breastfeeding (All women of childbearing potential will be required to have a screening urine or blood pregnancy test)

Electrocardiographic evidence of clinically relevant heart disease

Symptoms of coronary or cardiac insufficiency

More than one major risk factor for coronary artery disease (excluding age and sex)

Obesity (defined as a body mass index \> 30 kg/m\^2)

History of underlying conditions/risk factors associated with pulmonary hypertension such as collagen vascular disease, HIV infection, use of appetite suppressants, chronic liver disease or cirrhosis of the liver, chronic thromboembolic disease, congenital heart defects, hypoxemia and/or significant pulmonary parenchymal disease

Systemic hypertension that is not well controlled (i.e. blood pressure at the time of screening \>140/90 mmHg in adults \< 60 years old or \>150/90 mmHg in adults 60 years or older) on medications. Subjects taking \> 2 anti-hypertensive medications will be excluded irrespective of their current blood pressure at time of screening

Anemia, thrombocytopenia or coagulopathy

Renal insufficiency (defined as an estimated glomerular filtration rate of \< 60 mL/min/1.73m\^2 of body surface area)

Active tobacco use (\> 6 months) in the past ten years, any tobacco use within 3 months prior to the screening evaluation or any tobacco use prior to completion of the study

Inability to provide informed written consent for participation in the study

History of recreational drug use with the exception of marijuana (as long as marijuana use was \> 3 months from the time of study screening).

Volunteers may be excluded if in the opinion of the study investigators they have a condition that may adversely affect the outcome of the study or the safety of the volunteer. Exclusion Criteria for MRI in Healthy Control Subjects and Subjects with PAH These contraindications include but are not limited to the following devices or conditions:

Implanted cardiac pacemaker or defibrillator

Cochlear Implants

Ocular foreign body (e.g. metal shavings)

Embedded shrapnel fragments

Central nervous system aneurysm clips

Implanted neural stimulator

Any implanted device that is incompatible with MRI

Unsatisfactory performance status as judged by the referring physician such that the subject could not tolerate an MRI scan. Examples of medical conditions that would not be accepted would include unstable angina and severe dyspnea at rest

Subjects requiring monitored sedation for MRI studies

Subjects with a condition precluding entry into the scanner (e.g. morbid obesity, claustrophobia, etc.)

Subjects with severe back-pain or motion disorders who will be unable to tolerate supine positioning within the MRI scanner and hold still for the duration of the examination. Exclusion Criteria for Gadolinium Based MRI Studies Only:

History of severe allergic reaction to gadolinium contrast agents despite pre- medication with diphenhydramine and prednisone

Chronic kidney disease (an estimated glomerular filtration rate of \< 60 mL/min/1.73m\^2 of body surface area) Exclusion Criteria for Cardiac Computed Tomography in Healthy Control Subjects and Subjects with PAH: 1\) Subjects with a condition precluding entry into the scanner (e.g. morbid obesity, claustrophobia, etc.) Exclusion Criteria for Iodine Based Contrast CTA Studies Only:

Serum creatinine \> 1.4 mg/dL

History of multiple myeloma

Use of metformin-containing products less than 24 hours prior to contrast administration

History of significant allergic reaction to CTA contrast agents despite pre-medication with diphenhydramine and prednisone

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT01730092) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Pulmonary Disease Treatment Options in Bethesda, MD

If you're searching for pulmonary disease treatment options in Bethesda, MD, this clinical trial (NCT01730092) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this clinical trial. You'll receive care from experienced pulmonary disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all pulmonary disease clinical trials near you to find additional studies recruiting in your area.

Pulmonary Disease Clinical Trial in Bethesda, MD

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