Efficacy Study of Cardizem in Pulmonary Arterial Hypertension

University of South Florida

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Idiopathic Pulmonary Arterial Hypertension Primary Pulmonary Hypertension Pulmonary Arterial Hypertension Familial Primary Pulmonary Hypertension

Interventions

Diltiazem HydrochlorideDRUG

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.

Sugar PillDRUG

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of South Florida

Tampa, Florida, United States

Outcomes

Primary Outcomes

Six Minute Walk Distance

Time frame: 12 weeks

Secondary Outcomes

Dyspnea Score

Time frame: 12 weeks

Quality of Life Score

Time frame: 12 weeks

Pulse Oximetry

Time frame: 12 weeks

Data from ClinicalTrials.gov

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