Efficacy Study of Cardizem in Pulmonary Arterial Hypertension

Overview

The purpose of this study is to determine if cardizem is effective in the treatment of nitric oxide non-responder pulmonary arterial hypertension.

Full Title of Study: “Calcium Channel Blockers in Nitric Oxide Non-responder Pulmonary Arterial Hypertension.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: September 2014

Interventions

  • 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.
  • 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).

Arms, Groups and Cohorts

  • 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.
  • 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).

Clinical Trial Outcome Measures

Primary Measures

  • Six Minute Walk Distance
    • Time Frame: 12 weeks

Secondary Measures

  • Dyspnea Score
    • Time Frame: 12 weeks
  • Quality of Life Score
    • Time Frame: 12 weeks
  • Pulse Oximetry
    • Time Frame: 12 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of South Florida
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mark Rumbak, Professor of Medicine, Internal Medicine – University of South Florida
  • Overall Official(s)
    • Mark Rumbak, MD, Principal Investigator, University of South Florida

References

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.

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