Clinical trial NCT01645826: Efficacy Study of Cardizem in Pulmonary Arterial Hypertension
Official title: Calcium Channel Blockers in Nitric Oxide Non-responder Pulmonary Arterial Hypertension.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Idiopathic Pulmonary Arterial Hypertension
Primary Pulmonary Hypertension
Pulmonary Arterial Hypertension
Familial Primary Pulmonary Hypertension
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2012-07-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Six Minute Walk Distance
timeFrame: 12 weeks
Secondary outcomes:
measure: Dyspnea Score
timeFrame: 12 weeks
measure: Quality of Life Score
timeFrame: 12 weeks
measure: Pulse Oximetry
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Mark Rumbak, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: Galie N, Torbicki A, Barst R, Dartevelle P, Haworth S, Higenbottam T, Olschewski H, Peacock A, Pietra G, Rubin LJ, Simonneau G, Priori SG, Garcia MA, Blanc JJ, Budaj A, Cowie M, Dean V, Deckers J, Burgos EF, Lekakis J, Lindahl B, Mazzotta G, McGregor K, Morais J, Oto A, Smiseth OA, Barbera JA, Gibbs S, Hoeper M, Humbert M, Naeije R, Pepke-Zaba J; Task Force. Guidelines on diagnosis and treatment of pulmonary arterial hypertension. The Task Force on Diagnosis and Treatment of Pulmonary Arterial Hypertension of the European Society of Cardiology. Eur Heart J. 2004 Dec;25(24):2243-78. doi: 10.1016/j.ehj.2004.09.014. No abstract available.