Efficacy Study of Cardizem in Pulmonary Arterial Hypertension

Not Applicable

Withdrawn

• Conditions: Primary Pulmonary Hypertension; Familial Primary Pulmonary Hypertension; Idiopathic Pulmonary Arterial Hypertension; Pulmonary Arterial Hypertension
• Interventions: Drug: Diltiazem Hydrochloride; Drug: Sugar Pill

• Registration Number: NCT01645826
• Lead Sponsor: University of South Florida

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-18
• Study Start: 2012-07
• Study First Submitted QC: 2012-07-17
• Study First Posted: 2012-07-20
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-16
• Last Update Posted: 2018-11-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diltiazem	Diltiazem Hydrochloride	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.
Sugar Pill	Sugar Pill	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).

Primary Outcome Measures

Name	Time	Method
Six Minute Walk Distance	12 weeks

Secondary Outcome Measures

Name	Time	Method
Quality of Life Score	12 weeks
Pulse Oximetry	12 weeks
Dyspnea Score	12 weeks

Trial Locations

Locations (1)

University of South Florida; 🇺🇸 Tampa, Florida, United States