Efficacy Study of Cardizem in Pulmonary Arterial Hypertension

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01645826

Enrollment

Registered

2012-07-20

Start date

2012-07-31

Completion date

2014-09-30

Last updated

2018-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGDiltiazem Hydrochloride

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.

DRUGSugar Pill

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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Six Minute Walk Distance	12 weeks

Secondary

Measure	Time frame
Dyspnea Score	12 weeks
Quality of Life Score	12 weeks
Pulse Oximetry	12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026