RECRUITING

Natural History Study of Biomarkers in Pulmonary Arterial Hypertension

Conditions

Pulmonary Disease Pulmonary Hypertension Vascular Inflammation Microarray Right Ventricular Function Endothelial Dysfunction Magnetic Resonance Imaging Natural History

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Natural History Study of Novel Biomarkers in Pulmonary Arterial Hypertension

Quick Facts

Study Start:2013-07-15

Study Completion:N/A

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT01730092

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* mean pulmonary artery pressure of greater than 25 mmHg at rest, * pulmonary capillary wedge pressure of less than or equal to 15 mmHg (or a left ventricular end-diastolic pressure of less than or equal to 12mmHg) and * pulmonary vascular resistance of greater than 3 Wood units (240 dyn s cm(-5)).	* 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 * Must be eligible for MRI and Gadolinium Based MRI studies * Must be eligible for CT and Iodine Based Contrast CT studies * 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 greater than or equal to140/90 mmHg) in adults \< 60 years old or greater than or equal to 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. 1. Implanted cardiac pacemaker or defibrillator 2. Cochlear Implants 3. Ocular foreign body (e.g. metal shavings) 4. Embedded shrapnel fragments 5. Central nervous system aneurysm clips 6. Implanted neural stimulator 7. Any implanted device that is incompatible with MRI 8. 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 9. Subjects requiring monitored sedation for MRI studies 10. Subjects with a condition precluding entry into the scanner (e.g. morbid obesity, claustrophobia, etc.) 11. 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. 1. History of severe allergic reaction to gadolinium contrast agents despite pre- medication with diphenhydramine and prednisone 2. Chronic kidney disease (an estimated glomerular filtration rate of \< 60 mL/min/1.73m\^2 of body surface area) 1. Serum creatinine \> 1.4 mg/dL 2. History of multiple myeloma 3. Use of metformin-containing products less than 24 hours prior to contrast administration 4. History of significant allergic reaction to CTA contrast agents despite premedication with diphenhydramine and prednisone

Inclusion Criteria

Exclusion Criteria

* mean pulmonary artery pressure of greater than 25 mmHg at rest,
* pulmonary capillary wedge pressure of less than or equal to 15 mmHg (or a left ventricular end-diastolic pressure of less than or equal to 12mmHg) and
* pulmonary vascular resistance of greater than 3 Wood units (240 dyn s cm(-5)).

* 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
* Must be eligible for MRI and Gadolinium Based MRI studies
* Must be eligible for CT and Iodine Based Contrast CT studies
* 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 greater than or equal to140/90 mmHg) in adults \< 60 years old or greater than or equal to 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.
1. Implanted cardiac pacemaker or defibrillator
2. Cochlear Implants
3. Ocular foreign body (e.g. metal shavings)
4. Embedded shrapnel fragments
5. Central nervous system aneurysm clips
6. Implanted neural stimulator
7. Any implanted device that is incompatible with MRI
8. 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
9. Subjects requiring monitored sedation for MRI studies
10. Subjects with a condition precluding entry into the scanner (e.g. morbid obesity, claustrophobia, etc.)
11. 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.
1. History of severe allergic reaction to gadolinium contrast agents despite pre- medication with diphenhydramine and prednisone
2. Chronic kidney disease (an estimated glomerular filtration rate of \< 60 mL/min/1.73m\^2 of body surface area)
1. Serum creatinine \> 1.4 mg/dL
2. History of multiple myeloma
3. Use of metformin-containing products less than 24 hours prior to contrast administration
4. History of significant allergic reaction to CTA contrast agents despite premedication with diphenhydramine and prednisone

Contacts and Locations

Study Contact

Grace M Graninger, R.N.

CONTACT

(301) 496-9320

ggraninger@cc.nih.gov

Michael A Solomon, M.D.

CONTACT

(301) 496-9320

msolomon@cc.nih.gov

Principal Investigator

Michael A Solomon, M.D.

PRINCIPAL_INVESTIGATOR

National Institutes of Health Clinical Center (CC)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Institutes of Health Clinical Center (CC)

Michael A Solomon, M.D., PRINCIPAL_INVESTIGATOR, National Institutes of Health Clinical Center (CC)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2013-07-15

Study Completion DateN/A

Study Record Updates

Study Start Date2013-07-15

Study Completion DateN/A

Terms related to this study

Keywords Provided by Researchers

Vascular Inflammation
Microarray
Right Ventricular Function
Endothelial Dysfunction
Magnetic Resonance Imaging
Natural History

Additional Relevant MeSH Terms

Pulmonary Disease
Pulmonary Hypertension