NCT01389206

Brief Summary

Knowledge Translation Program for the guidelines and evidence-based management of PAH patients

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
797

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

Longer than P75 for all trials

Geographic Reach
2 countries

76 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 6, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 8, 2011

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2018

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

6.9 years

First QC Date

July 6, 2011

Last Update Submit

August 14, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patients achieving guideline-recommended treatment

    Proportion of patients achieving guideline-recommended treatment

    3 years

Secondary Outcomes (1)

  • Patients achieving optimal functional class

    3 years

Study Arms (1)

Standard of care

Observational study to improve the management of PAH patients through an evidence-based approach aimed at achieving optimal WHO functional class (FC) treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi.

Drug: observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi

Interventions

observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi

Standard of care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Approximately 800 PAH patients from approximately 80 physician practices will be included in the program.

You may qualify if:

  • Male and female adults (≥ 18 years of age)
  • Documented diagnosis of PAH (all of the following): i. RHC demonstrating mPAP \> 25 mm Hg and PCWP
  • ≤ 15 and PVR \> 3 ii. FEV 1 \> 50% predicted normal iii. V/Q and/or CT scan excluding the thromboembolic etiology
  • Diagnosis of PAH \< 3 years
  • Need for PAH specific treatment
  • Desire to participate and signs an informed consent

You may not qualify if:

  • Any of the criteria below:
  • Poor mental function, drug or substance (e.g.,alcohol) abuse, or unstable psychiatric illness, which, in the opinion of the investigator, may interfere with optimal participation in the study
  • Prior participation in this program
  • Patients with pulmonary hypertension classified as group 2 - 5 Updated Clinical Classification of Pulmonary Hypertension (5th World Symposium on PH Modified Classification of PH)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (76)

Cardiovascular Associates, PC

Birmingham, Alabama, 35216, United States

Location

University of South Alabama Medical Center

Mobile, Alabama, 36617, United States

Location

Pulmonary Associates

Phoenix, Arizona, 85006, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Alliance Medical and Research Center

Fountain Valley, California, 92866, United States

Location

Scripps Clinic, Scripps Green Hospital

La Jolla, California, 92037, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Paloma Medical Group

San Juan Capistrano, California, 92675, United States

Location

Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

South Denver Cardiology Associates PC

Littleton, Colorado, 80120, United States

Location

Robert E. Benkert, M.D.P.C.

Wheat Ridge, Colorado, 80033, United States

Location

Lung Health & Sleep Enhancement Center, LLC

Newark, Delaware, 19713, United States

Location

Bay Area Cardiology Research, P.A.

Brandon, Florida, 33511, United States

Location

Bay Area Chest Physicians

Clearwater, Florida, 33756, United States

Location

Broward Pulmonary and Sleep Specialists

Fort Lauderdale, Florida, 33316, United States

Location

Pulmonary Diseases, Internal Medicine, Critical Care Medicine

Fort Lauderdale, Florida, 33334, United States

Location

Mount Sinai Medical Centre - Columbia University - Division of Cardiology

Miami Beach, Florida, 33140, United States

Location

Central Florida Pulmonary Group, PA

Orlando, Florida, 32803, United States

Location

Lung Associates of Sarasota

Sarasota, Florida, 34239, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Unity Point Health Pulmonary Services

Peoria, Illinois, 61602, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52301, United States

Location

Kentuckiana Pulmonary Associates

Louisville, Kentucky, 40202, United States

Location

University of Louisville School of Medicine

Louisville, Kentucky, 40202, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

University of Maryland Medical Centre

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

University of Michigan Pulmonary Hypertension Program

Ann Arbor, Michigan, 48109, United States

Location

Wayne State University, Detroit Medical Center

Detroit, Michigan, 48324, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49525, United States

Location

William Beaumont Hospital - Troy

Troy, Michigan, 48085, United States

Location

Nebraska Pulmonary Specialties, LLC

Lincoln, Nebraska, 68506, United States

Location

Creighton University Medical Centre - Pulmonary, Critical Care and Sleep Medicine Division

Omaha, Nebraska, 68131, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-5300, United States

Location

The Lung Center of Nevada

Las Vegas, Nevada, 89128, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0001, United States

Location

Michael Schwarz, MDFACC

Bloomfield, New Jersey, 07003, United States

Location

Respiratory Health & Critical Care Associates

Hawthorne, New Jersey, 07506, United States

Location

Pulmonary Hypertension & Lung Transplant Program Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

North Shore - LIJ Health System

New Hyde Park, New York, 11040, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Wake Forest University Phyisicans Clinic/Pulmonary

Winston-Salem, North Carolina, 27157, United States

Location

The Christ Hospital Heart & Vascular Center

Cincinnati, Ohio, 45219, United States

Location

University of Cincinnati Pulmonary Critical Care & Sleep Medicine

Cincinnati, Ohio, 45219, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Dayton Respiratory Center

Dayton, Ohio, 45215, United States

Location

University of Toledo Health Sciences Campus

Toledo, Ohio, 43614, United States

Location

Heart Center Cardiology

Bend, Oregon, 97701, United States

Location

Central Bucks Specialists - The Pavilion at Doylestown Hospital

Doylestown, Pennsylvania, 18901, United States

Location

Institute for Respiratory and Sleep Medicine

Langhorne, Pennsylvania, 19007, United States

Location

Pulmonary Hypertension Program, Cardiology, Children's Hospial of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Pulmonary Vascular Disease Program, Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Respiratory Specialists

Wyomissing, Pennsylvania, 19610, United States

Location

Wellspan Lung, Sleep and Critical Care

York, Pennsylvania, 17402, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Sioux Falls Cardiovascular PC

Sioux Falls, South Dakota, 57103, United States

Location

Statcare Pulmonary Consultants

Knoxville, Tennessee, 37919, United States

Location

El Paso Respiratory and Sleep Consultants

El Paso, Texas, 79902, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

UT Health - University of Texas Houston

Houston, Texas, 77030, United States

Location

Providence Health Center

Waco, Texas, 76712, United States

Location

IHVI, Advanced Lung Disease and Transplant Clinic

Falls Church, Virginia, 22042, United States

Location

Sentara Medical Group

Norfolk, Virginia, 23507, United States

Location

Cardiac Study Center

Puyallup, Washington, 98372, United States

Location

PAH Clinic CPR at Auxilio Mutuo

San Juan, 00918, Puerto Rico

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

ObservationBosentanIloprostEpoprostenol

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative TechniquesBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsProstaglandins I

Study Officials

  • Vallerie McLaughlin, MD

    University of Michigan

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2011

First Posted

July 8, 2011

Study Start

June 1, 2011

Primary Completion

April 10, 2018

Study Completion

April 10, 2018

Last Updated

August 15, 2018

Record last verified: 2018-08

Locations