Efficacy Study of Cardizem in Pulmonary Arterial Hypertension

Condition(s) targeted: Idiopathic Pulmonary Arterial Hypertension; Primary Pulmonary Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension

Intervention: Diltiazem Hydrochloride (Drug); Sugar Pill (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of South Florida

Official(s) and/or principal investigator(s):
Mark Rumbak, MD, Principal Investigator, Affiliation: University of South Florida

Overall contact:
Mark Rumbak, MD, Phone: 813-974-2201, Email: mrumbak@health.usf.edu

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

Official title: Calcium Channel Blockers in Nitric Oxide Non-responder Pulmonary Arterial Hypertension.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Six Minute Walk Distance

Secondary outcome:

Dyspnea Score

Quality of Life Score

Pulse Oximetry

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Mark Rumbak, MD, Phone: 813-974-2201, Email: mrumbak@health.usf.edu

University of South Florida, Tampa, Florida 33612, United States; Recruiting
Mark Rumbak, MD, Phone: 814-974-2201, Email: mrumbak@health.usf.edu
Cao Kimberley, MD, Phone: 813-974-2201, Email: kcao@health.usf.edu
Mark Rumbak, MD, Principal Investigator
Kimberley Cao, MD, Sub-Investigator
Chakrapol Sriaroon, MD, Sub-Investigator
David Solomon, MD, Sub-Investigator

Robbins, Ivan. The Role of Calcium Channel Blockers in Pulmonary Arterial Hypertension. 2006 Feb 23.

Related publications:

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.

Aromatorio GJ, Uretsky BF, Reddy PS. Hypotension and sinus arrest with nifedipine in pulmonary hypertension. Chest. 1985 Feb;87(2):265-7.

Batra AK, Segall PH, Ahmed T. Pulmonary edema with nifedipine in primary pulmonary hypertension. Respiration. 1985;47(3):161-3.

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.

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.

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. Review.

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.

Galiè 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.

Starting date: July 2012
Last updated: September 6, 2013