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Efficacy Study of Cardizem in Pulmonary Arterial Hypertension

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ClinicalTrials.gov Identifier: NCT01645826
Recruitment Status : Unknown
Verified September 2013 by Mark Rumbak, University of South Florida.
Recruitment status was:  Recruiting
First Posted : July 20, 2012
Last Update Posted : September 9, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Idiopathic Pulmonary Arterial Hypertension Primary Pulmonary Hypertension Pulmonary Arterial Hypertension Familial Primary Pulmonary Hypertension Drug: Diltiazem Hydrochloride Drug: Sugar Pill

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Calcium Channel Blockers in Nitric Oxide Non-responder Pulmonary Arterial Hypertension.
Study Start Date : July 2012
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : November 2014

Arms and Interventions

Arm Intervention/treatment
Experimental: Diltiazem
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
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.
Other Names:
  • cardizem
  • treatment group
Placebo Comparator: 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).
Drug: Sugar 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).
Other Name: placebo

Outcome Measures

Primary Outcome Measures :
  1. Six Minute Walk Distance [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Dyspnea Score [ Time Frame: 12 weeks ]
  2. Quality of Life Score [ Time Frame: 12 weeks ]
  3. Pulse Oximetry [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01645826

Contact: Mark Rumbak, MD 813-974-2201 mrumbak@health.usf.edu
Contact: Kimberley Cao, MD 813-974-2201 kcao@health.usf.edu

United States, Florida
University of South Florida Recruiting
Tampa, Florida, United States, 33612
Contact: Mark Rumbak, MD    814-974-2201    mrumbak@health.usf.edu   
Contact: Cao Kimberley, MD    813-974-2201    kcao@health.usf.edu   
Principal Investigator: Mark Rumbak, MD         
Sub-Investigator: Kimberley Cao, MD         
Sub-Investigator: Chakrapol Sriaroon, MD         
Sub-Investigator: David Solomon, MD         
Sponsors and Collaborators
University of South Florida
Principal Investigator: Mark Rumbak, MD University of South Florida
More Information

Additional Information:

Responsible Party: Mark Rumbak, Professor of Medicine, Internal Medicine, University of South Florida
ClinicalTrials.gov Identifier: NCT01645826     History of Changes
Other Study ID Numbers: Pro00004379
First Posted: July 20, 2012    Key Record Dates
Last Update Posted: September 9, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Calcium Channel Blockers
Antihypertensive Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents