CClinicalTrials.gg
Sign In
WithdrawnNCT01645826Updated Nov 20, 2018

Efficacy Study of Cardizem in Pulmonary Arterial Hypertension

An interventional study of Diltiazem Hydrochloride and Sugar Pill in Idiopathic Pulmonary Arterial Hypertension, Primary Pulmonary Hypertension and Pulmonary Arterial Hypertension, sponsored by University of South Florida. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-20.

Sponsored by University of South Florida · Not applicable, Interventional, and Treatment

Why this study was withdrawn
no participants agreed to enroll since study start
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Idiopathic Pulmonary Arterial Hypertension
  • Primary Pulmonary Hypertension
  • Pulmonary Arterial Hypertension
  • Familial Primary Pulmonary Hypertension
03

In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

Browse Hypertension, Pulmonary studies →

Lead sponsor

University of South Florida is the lead sponsor of 333 studies on the registry; 63 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
0 participants (actual)

Study arms

  • 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.

    Drug: Diltiazem Hydrochloride

  • 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).

    Drug: Sugar Pill

Interventions

  • DrugDiltiazem 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.

    Also known as: cardizem, treatment group

  • DrugSugar 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).

    Also known as: placebo

06

What researchers measure

Primary outcomes

  1. Six Minute Walk Distance

    Time frame: 12 weeks

Secondary outcomes

  1. Dyspnea Score

    Time frame: 12 weeks

  2. Quality of Life Score

    Time frame: 12 weeks

  3. Pulse Oximetry

    Time frame: 12 weeks

07

Study locations

1 site
  • University of South Florida
    Tampa, Florida 33612, United States
08

References and documents

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. doi: 10.1378/chest.06-2674. PubMed 17565025 ↗
  • 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. PubMed 3967536 ↗
  • Batra AK, Segall PH, Ahmed T. Pulmonary edema with nifedipine in primary pulmonary hypertension. Respiration. 1985;47(3):161-3. doi: 10.1159/000194763. PubMed 4001571 ↗
  • 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. PubMed 8705766 ↗
  • 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. PubMed 8361869 ↗
  • 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. PubMed 6831965 ↗
  • 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. PubMed 11115457 ↗
  • 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. PubMed 21941650 ↗
  • Nauser TD, Stites SW. Diagnosis and treatment of pulmonary hypertension. Am Fam Physician. 2001 May 1;63(9):1789-98. PubMed 11352291 ↗
  • 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. PubMed 19389575 ↗
  • 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. PubMed 15589643 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01645826
Lead sponsor
University of South Florida
Responsible party
Mark Rumbak (Professor of Medicine, Internal Medicine, University of South Florida) — Principal investigator
First posted
Jul 20, 2012
Start date
Jul 2012
Primary completion
Sep 2014
Completion
Sep 2014
Last update
Nov 20, 2018

Study contacts

Mark Rumbak, MD
principal investigator · University of South Florida

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hypertension, Pulmonary→

Other studies from this sponsor

University of South Florida

Start the discussion