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NCT00352430 · ClinicalTrials.gov registry record · Phase 1
Cardiopulmonary Function Assessment and NO-Based Therapies for Patients With Hemolysis-Associated Pulmonary Hypertension
A Phase 1 study of Pulmonary Hypertension, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT00352430 is a Phase 1 study of Pulmonary Hypertension that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 31 participants, below the 613-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00352430, a Phase 1 study of Pulmonary Hypertension, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate new treatments for people who have pulmonary hypertension, or high blood pressure in the lungs, caused by sickle cell anemia or thalassemia. Patients ages 18 and older with a diagnosis of sickle cell disease or thalassemia, who have mild to severe pulmonary hypertension, and who are not pregnant or breastfeeding may be eligible for this study. There are three stages in the study, with up to 200 participants in the screening. Patients will undergo pulmonary function tests, including those for asthma and measurement of oxygen levels in the arterial blood. They will have a chest X-ray, computed tomography (CT) scan of the lungs, ventilation perfusion lung scan to look for blood clots, echocardiogram, test to measure how far patients can walk in 6 minutes, nighttime oxygen measurement done while asleep, blood collection, magnetic resonance imaging (MRI) scan of the heart, and exercise test. About 3 to 4 days are needed for the tests, all of which can be done while patients are outpatients, except for the sleep study. For the CT scan, patients lie on a table while an X-ray beam takes images of the lungs and heart. The lung scan involves breathing of a small amount of a radioactive aerosol called Tc99m DTPA while pictures are taken of the lungs from various angles. Then an injection of albumin, a protein with a small amount of radioactivity, will be given, and more lung pictures will be taken. For the MRI scan, patients lie on a table that slides into a machine. A medication called gadolinium will be injected, to help improve images made through the scan. After the tests, patients will be admitted to the Clinical Center for 1 day. A small plastic catheter, or tube, will be placed in the vein of an arm. A longer catheter will go into a deeper vein (neck or leg), and a pulmonary artery catheter will be inserted to measure blood pressure in the blood vessels. Doctors will guide the catheter into the lung artery. Patients will be asked to pedal on a
Conditions Studied
Interventions
- DRUG Nitric Oxide/INP Pulse Delivery
- DRUG Nitric Oxide/INO Pulse Delivery
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2006-07-09 |
| Est. Completion | 2010-03-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00352430
The ClinicalTrials.gov registry entry for NCT00352430 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 613-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (95% lower). The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pulmonary Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Nitric Oxide/INP Pulse Delivery is the first listed.
NCT00352430 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00352430 about?
NCT00352430 is a clinical study titled "Cardiopulmonary Function Assessment and NO-Based Therapies for Patients With Hemolysis-Associated Pulmonary Hypertension". This study will evaluate new treatments for people who have pulmonary hypertension, or high blood pressure in the lungs, caused by sickle cell anemia or thalassemia. Patients ages 18 and older with a diagnosis of sickle cell disease or thalassemia, who have mild to severe pulmonary hypertension, an...
What is the current status of trial NCT00352430?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2006-07-09. Estimated completion is 2010-03-10.
What conditions does trial NCT00352430 study?
This clinical trial studies the following conditions: Pulmonary Hypertension.
What interventions are being tested in trial NCT00352430?
The interventions under investigation include: Nitric Oxide/INP Pulse Delivery (DRUG), Nitric Oxide/INO Pulse Delivery (DRUG).
Who is sponsoring clinical trial NCT00352430?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00352430 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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