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Efficacy Study of Cardizem in Pulmonary Arterial Hypertension

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ClinicalTrials.gov Identifier: NCT01645826
Recruitment Status : Withdrawn (no participants agreed to enroll since study start)
First Posted : July 20, 2012
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Mark Rumbak, University of South Florida

Study Description
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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 Phase
Idiopathic Pulmonary Arterial Hypertension Primary Pulmonary Hypertension Pulmonary Arterial Hypertension Familial Primary Pulmonary Hypertension Drug: Diltiazem Hydrochloride Drug: Sugar Pill Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 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
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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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


Locations
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United States, Florida
University of South Florida
Tampa, Florida, United States, 33612
Sponsors and Collaborators
University of South Florida
Investigators
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Principal Investigator: Mark Rumbak, MD University of South Florida
More Information
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Additional Information:

Publications:
McLaughlin VV, Archer SL, Badesch DB, Barst RJ, Farber HW, Lindner JR, Mathier MA, McGoon MD, Park MH, Rosenson RS, Rubin LJ, Tapson VF, Varga J; American College of Cardiology Foundation Task Force on Expert Consensus Documents; American Heart Association; American College of Chest Physicians; American Thoracic Society, Inc; Pulmonary Hypertension Association. ACCF/AHA 2009 expert consensus document on pulmonary hypertension a report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents and the American Heart Association developed in collaboration with the American College of Chest Physicians; American Thoracic Society, Inc.; and the Pulmonary Hypertension Association. J Am Coll Cardiol. 2009 Apr 28;53(17):1573-619. doi: 10.1016/j.jacc.2009.01.004. No abstract available.

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Responsible Party: Mark Rumbak, Professor of Medicine, Internal Medicine, University of South Florida
ClinicalTrials.gov Identifier: NCT01645826    
Other Study ID Numbers: Pro00004379
First Posted: July 20, 2012    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Pulmonary Arterial Hypertension
Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
 Diltiazem
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents