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Efficacy Study of Cardizem in Pulmonary Arterial Hypertension

This study is currently recruiting participants.
Verified September 2013 by University of South Florida
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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dyspnea Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Quality of Life Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Pulse Oximetry [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
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:

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
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014