Efficacy Study of Cardizem in Pulmonary Arterial Hypertension
NCT ID: NCT01645826
Last Updated: 2018-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2012-07-31
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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).
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).
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of South Florida
OTHER
Responsible Party
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Mark Rumbak
Professor of Medicine, Internal Medicine
Principal Investigators
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Mark Rumbak, MD
Role: PRINCIPAL_INVESTIGATOR
University of South Florida
Locations
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University of South Florida
Tampa, Florida, United States
Countries
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References
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Badesch DB, Abman SH, Simonneau G, Rubin LJ, McLaughlin VV. Medical therapy for pulmonary arterial hypertension: updated ACCP evidence-based clinical practice guidelines. Chest. 2007 Jun;131(6):1917-28. doi: 10.1378/chest.06-2674.
Aromatorio GJ, Uretsky BF, Reddy PS. Hypotension and sinus arrest with nifedipine in pulmonary hypertension. Chest. 1985 Feb;87(2):265-7. doi: 10.1378/chest.87.2.265.
Batra AK, Segall PH, Ahmed T. Pulmonary edema with nifedipine in primary pulmonary hypertension. Respiration. 1985;47(3):161-3. doi: 10.1159/000194763.
Chaouat A, Kessler R, Weitzenblum E. Pulmonary oedema and pleural effusion in two patients with primary pulmonary hypertension treated with calcium channel blockers. Heart. 1996 Apr;75(4):383. doi: 10.1136/hrt.75.4.383. No abstract available.
Clarke WR, Horn JR, Kawabori I, Gurtel S. Potentially serious drug interactions secondary to high-dose diltiazem used in the treatment of pulmonary hypertension. Pharmacotherapy. 1993 Jul-Aug;13(4):402-5.
Farber HW, Karlinsky JB, Faling LJ. Fatal outcome following nifedipine for pulmonary hypertension. Chest. 1983 Apr;83(4):708-9. doi: 10.1378/chest.83.4.708. No abstract available.
Holcomb BW Jr, Loyd JE, Ely EW, Johnson J, Robbins IM. Pulmonary veno-occlusive disease: a case series and new observations. Chest. 2000 Dec;118(6):1671-9.
Houtchens J, Martin D, Klinger JR. Diagnosis and management of pulmonary arterial hypertension. Pulm Med. 2011;2011:845864. doi: 10.1155/2011/845864. Epub 2011 Sep 20.
Nauser TD, Stites SW. Diagnosis and treatment of pulmonary hypertension. Am Fam Physician. 2001 May 1;63(9):1789-98.
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.
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.
Related Links
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Robbins, Ivan. The Role of Calcium Channel Blockers in Pulmonary Arterial Hypertension. 2006 Feb 23.
Other Identifiers
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Pro00004379
Identifier Type: -
Identifier Source: org_study_id
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