Clinical Trials

5 studies in Pulmonary Arterial Hypertension

1. Effects of the Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Pulmonary Arterial Hypertension (PAH) Jacksonville, FL Rochester, MN View Summary
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   Effects of the Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Pulmonary Arterial Hypertension (PAH)

   Location:

   Jacksonville, FL Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   This study will investigate the effects of the combination of bosentan and sildenafil. Patients with symptomatic PAH treated with a stable dose of sildenafil equal to or greater tha 20 mg t.i.d. for at least 12 weeks will be randomized to placebo or bosentan 125 mg b.i.d. All randomized patients will be treated with study drug until the predefined target number of morbidity/mortality events is reached.

   NCT ID:

   NCT00303459

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   Who can I contact for additional information about this study?

   Rochester: Karen Swanson, MD 507-284-1838
                       Louise Durst 507-284-1838
   
   Jacksonville: Charles Burger, MD 904-953-2381
                       Pamela Long 904-953-7719
   

2. Study of Incidence of Respiratory Tract Adverse Events in Patients Treated With Tyvaso® Compared to Other FDA Approved Pulmonary Arterial Hypertension (PAH) Therapies Jacksonville, FL Rochester, MN View Summary
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   Study of Incidence of Respiratory Tract Adverse Events in Patients Treated With Tyvaso® Compared to Other FDA Approved Pulmonary Arterial Hypertension (PAH) Therapies

   Location:

   Jacksonville, FL Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   A post marketing surveillance to determine the type and incidence of oro/nasopharyngeal or pulmonary adverse events that may occur in patients treated with commercially available Tyvaso®(treprostinil) Inhalation Solution. A comparison will be made to the type and incidence of events in patients receiving other FDA approved therapies for pulmonary arterial hypertension, as a control measure.

   NCT ID:

   NCT01266265

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   Who can I contact for additional information about this study?

   Rochester: Louise Durst
                       
   
   Jacksonville: Shannon Kennedy 904-953-7439
                       
   

3. Early Detection of Pulmonary Arterial Hypertension Using Cardiac Magnetic Resonance Imaging Jacksonville, FL View Summary
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   Early Detection of Pulmonary Arterial Hypertension Using Cardiac Magnetic Resonance Imaging

   Location:

   Jacksonville, FL

   Trial status:

   Open for Enrollment

   Why is this study being done?

   Cardiac magnetic resonance imaging has emerged as a potential valuable test for the early detection of Pulmonary Arterial Hypertension. A number of reports have provided some preliminary evidence that Pulmonary Artery (PA) stiffness may be accurately detected by imaging of the pulmonary artery in order to measure PA stiffness. In addition, cardiac MRI could play provide early and effective treatment for Pulmonary Arterial Hypertension (PAH).

   NCT ID:

   NCT01451255

   IRB Number:

   11-002576

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   Who can I contact for additional information about this study?

   
   
   Jacksonville: Kellie A Ruday
                       
   

4. Assessmet of Patients With PAH Right Ventricular Volume Rochester, MN View Summary
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   Assessmet of Patients With PAH Right Ventricular Volume

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   The objective of this study is: The comparison of the VMS and MRI values for EDV, ESV, and EF using 75 subjects. Secondary objectives are: The determination of VMS inter-observer and intra-observer variability of these quantities using 30 subjects.

   NCT ID:

   NCT01557582

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   Who can I contact for additional information about this study?

   Rochester: Robert Frantz, MD
                       Jill Boyum 507-266-3180
   
   
   

5. Inhaled Nitric Oxide/INOpulse DS for Pulmonary Arterial Hypertension (PAH) Rochester, MN View Summary
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   Inhaled Nitric Oxide/INOpulse DS for Pulmonary Arterial Hypertension (PAH)

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   Study to determine if inhaled nitric oxide (iNO) given through a special delivery device (INOpulse® DS) is safe and efficacious in treating Pulmonary Arterial Hypertension (PAH). Medical literature and clinical experience suggests that iNO at pulsed doses of 0.013 to 0.1 mg/kg per hour for 1 month to 2+ years appears safe and suggests efficacy for the treatment of pulmonary hypertension. There are two parts to this study. In Part 1 (week 0 to week 16), the objectives are to determine the safety, tolerability, efficacy, and exploratory objectives of two different doses of iNO delivered by a pulsed delivery device in symptomatic subjects with PAH who remain symptomatic due to PAH on approved PAH monotherapy or combination approved PAH therapy. In Part 2 (week 17 to end of study Part 2 [EOS Part 2]), the objective is to compile data on the long-term effects of iNO on safety, tolerability, clinical and hemodynamic measures.

   NCT ID:

   NCT01457781

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   Who can I contact for additional information about this study?

   - Mayo Clinic Cancer Center - Phone: 507-538-7623 - Research Volunteer Program - Phone: 1-800-664-4542 (toll-free) Email: clinicaltrials@mayo.edu - International Research - Phone: 507-284-8884 Email: intl.mcr@mayo.edu