Efficacy Study of Cardizem in Pulmonary Arterial Hypertension

Study Overview
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Brief Summary
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The purpose of this study is to determine if cardizem is effective in the treatment of nitric oxide non-responder pulmonary arterial hypertension.

Official Title
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Calcium Channel Blockers in Nitric Oxide Non-responder Pulmonary Arterial Hypertension.

Conditions
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Idiopathic Pulmonary Arterial Hypertension, Primary Pulmonary Hypertension, Pulmonary Arterial Hypertension, Familial Primary Pulmonary Hypertension

Intervention / Treatment
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* Drug: Diltiazem Hydrochloride
* Drug: Sugar Pill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult participants Confirmed WHO class I pulmonary arterial hypertension Nitric Oxide Non-Responders on right heart catheterization Experience dyspnea, NYHA III-IV with poor oxygenation and quality of life despite standard treatments Must be able to swallow medications Exclusion Criteria: Pulmonary hypertension secondary to 1) elevations in pulmonary venous pressures (i.e. left heart disease), 2) chronic hypoxemic states from lung diseases such as COPD, sleep-disordered breathing, alveolar hypoventilation disorders, chronic exposure to high altitude and developmental abnormalities 3) chronic thromboembolic disease, 4) sarcoidosis, 5) Lymphangiomyomatosis, 5) Pulmonary Langerhans Cell Histiocytosis Already on a calcium channel blocker Systolic blood pressure less than 90 Heart rate less than 55 Pregnant Cannot sign informed consent Right heart failure Pulmonary Veno-occlusive disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diltiazem<br>The study agent will be Diltiazem and will start at 60 mg po BID then titrated up every two weeks until at a maximum dose of 180mg po BID. | Drug: Diltiazem Hydrochloride<br>* The study agent will be diltiazem and will start at 60 mg po BID then titrated up very two weeks until at a maximum maintenance dose of 180mg po BID for six weeks.<br>* Other names: treatment group;|
| Placebo Comparator: Sugar Pill<br>The placebo group of patients will be treated with Drug A (sugar pill) PO bid and titrated up every two weeks for next titration dose (actually will be an unchanged concentration). | Drug: Sugar Pill<br>* The placebo group of patients will be treated with sugar pill PO bid and return every two weeks for next titration dose (actually will be an unchanged concentration).<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six Minute Walk Distance |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea Score |  | 12 weeks | 
| Quality of Life Score |  | 12 weeks | 
| Pulse Oximetry |  | 12 weeks |