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Efficacy Study of Cardizem in Pulmonary Arterial Hypertension

Primary Purpose

Idiopathic Pulmonary Arterial Hypertension, Primary Pulmonary Hypertension, Pulmonary Arterial Hypertension

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Diltiazem Hydrochloride

Sugar Pill

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Arterial Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of South Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Diltiazem

Sugar Pill

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Six Minute Walk Distance

Secondary Outcome Measures

Dyspnea Score

Quality of Life Score

Pulse Oximetry

Full Information

NCT ID

NCT01645826

First Posted

October 18, 2011

Last Updated

November 16, 2018

Sponsor

University of South Florida

1. Study Identification

Unique Protocol Identification Number

NCT01645826

Brief Title

Efficacy Study of Cardizem in Pulmonary Arterial Hypertension

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Withdrawn

Why Stopped

no participants agreed to enroll since study start

Study Start Date

July 2012 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of South Florida

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Idiopathic Pulmonary Arterial Hypertension, Primary Pulmonary Hypertension, Pulmonary Arterial Hypertension, Familial Primary Pulmonary Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diltiazem

Arm Type

Experimental

Arm Description

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.

Arm Title

Sugar Pill

Arm Type

Placebo Comparator

Arm Description

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).

Intervention Type

Drug

Intervention Name(s)

Diltiazem Hydrochloride

Other Intervention Name(s)

cardizem, treatment group

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Sugar Pill

Other Intervention Name(s)

placebo

Intervention Description

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).

Primary Outcome Measure Information:

Title

Six Minute Walk Distance

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Dyspnea Score

Time Frame

12 weeks

Title

Quality of Life Score

Time Frame

12 weeks

Title

Pulse Oximetry

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Rumbak, MD

Organizational Affiliation

University of South Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of South Florida

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

17565025

Citation

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.

Results Reference

background

PubMed Identifier

3967536

Citation

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.

Results Reference

background

PubMed Identifier

4001571

Citation

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

Results Reference

background

PubMed Identifier

8705766

Citation

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.

Results Reference

background

PubMed Identifier

8361869

Citation

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.

Results Reference

background

PubMed Identifier

6831965

Citation

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.

Results Reference

background

PubMed Identifier

11115457

Citation

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.

Results Reference

background

PubMed Identifier

21941650

Citation

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.

Results Reference

background

PubMed Identifier

11352291

Citation

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

Results Reference

background

PubMed Identifier

19389575

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.

Results Reference

background

PubMed Identifier

15589643

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.

Results Reference

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Links:

URL

http://www.medscape.org/viewarticle/523338

Description

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

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Efficacy Study of Cardizem in Pulmonary Arterial Hypertension

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