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Efficacy Study of Cardizem in Pulmonary Arterial Hypertension

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2013 by University of South Florida.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Mark Rumbak, University of South Florida
ClinicalTrials.gov Identifier:
NCT01645826
First received: October 18, 2011
Last updated: September 6, 2013
Last verified: September 2013
  Purpose
The purpose of this study is to determine if cardizem is effective in the treatment of nitric oxide non-responder pulmonary arterial hypertension.

Condition Intervention
Idiopathic Pulmonary Arterial Hypertension
Primary Pulmonary Hypertension
Pulmonary Arterial Hypertension
Familial Primary Pulmonary Hypertension
Drug: Diltiazem Hydrochloride
Drug: Sugar Pill

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Calcium Channel Blockers in Nitric Oxide Non-responder Pulmonary Arterial Hypertension.

Resource links provided by NLM:


Further study details as provided by University of South Florida:

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

Secondary Outcome Measures:
  • Dyspnea Score [ Time Frame: 12 weeks ]
  • Quality of Life Score [ Time Frame: 12 weeks ]
  • Pulse Oximetry [ Time Frame: 12 weeks ]

Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01645826

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

Locations
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
Investigators
Principal Investigator: Mark Rumbak, MD University of South Florida
  More Information

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.

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
Study First Received: October 18, 2011
Last Updated: September 6, 2013

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

ClinicalTrials.gov processed this record on March 24, 2017