Efficacy Study of Cardizem in Pulmonary Arterial Hypertension

NCT01645826 | Withdrawn DMC

• 1 other identifier: Pro00004379
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Pulmonary Arterial Hypertension; Primary Pulmonary Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Six Minute Walk Distance

  12 weeks

Secondary Outcomes (3)

• Dyspnea Score

  12 weeks

• Quality of Life Score

  12 weeks

• Pulse Oximetry

  12 weeks

Study Arms (2)

Diltiazem

EXPERIMENTAL

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

Sugar Pill

PLACEBO COMPARATOR

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

Interventions

Diltiazem Hydrochloride DRUG

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.

Also known as: cardizem, treatment group

Diltiazem

Sugar Pill DRUG

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).

Also known as: placebo

Sugar Pill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

Location

Related Publications (11)

• 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.

  PMID: 17565025 BACKGROUND

• 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.

  PMID: 3967536 BACKGROUND

• Batra AK, Segall PH, Ahmed T. Pulmonary edema with nifedipine in primary pulmonary hypertension. Respiration. 1985;47(3):161-3. doi: 10.1159/000194763.

  PMID: 4001571 BACKGROUND

• 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.

  PMID: 8705766 BACKGROUND

• 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.

  PMID: 8361869 BACKGROUND

• 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.

  PMID: 6831965 BACKGROUND

• 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.

  PMID: 11115457 BACKGROUND

• 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.

  PMID: 21941650 BACKGROUND

• Nauser TD, Stites SW. Diagnosis and treatment of pulmonary hypertension. Am Fam Physician. 2001 May 1;63(9):1789-98.

  PMID: 11352291 BACKGROUND

• 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.

  PMID: 19389575 BACKGROUND

• 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.

  PMID: 15589643 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Familial Primary Pulmonary Hypertension; Pulmonary Arterial Hypertension

Interventions

Diltiazem; Sugars

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Carbohydrates

Study Officials

• Mark Rumbak, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Internal Medicine

Study Record Dates

• First Submitted: October 18, 2011
• First Posted: July 20, 2012
• Study Start: July 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 20, 2018

Record last verified: 2018-11

Locations

US (1)