Efficacy Study of Cardizem in Pulmonary Arterial Hypertension

University of South Florida

Status: Withdrawn

Conditions: Familial Primary Pulmonary Hypertension; Idiopathic Pulmonary Arterial Hypertension; Primary Pulmonary Hypertension; Pulmonary Arterial Hypertension

Treatments: Drug: Sugar Pill; Drug: Diltiazem Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT01645826

Pro00004379

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Diltiazem

Experimental group

Description:

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.

Treatment:

Drug: Diltiazem Hydrochloride

Sugar Pill

Placebo Comparator group

Description:

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).

Treatment:

Drug: Sugar Pill