NCT01980979

Brief Summary

The purpose of this study is to evaluate the efficacy of Remodulin in the treatment of adult patients with congenital heart disease and pulmonary hypertension. Baseline and post-treatment cardiopulmonary exercise tests will be performed.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
withdrawn

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

First Submitted

Initial submission to the registry

September 24, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 11, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 21, 2017

Status Verified

September 1, 2017

Enrollment Period

2.1 years

First QC Date

September 24, 2013

Last Update Submit

September 19, 2017

Conditions

Congenital Heart Disease

Keywords

congenital heart disease,pulmonary hypertension,prostacyclin

Outcome Measures

Primary Outcomes (1)

  • Improved cardiopulmonary exercise test

    Change in 6 minute walk distance after 6 months of escalating Subcutaneous (SQ) remodulin as compared to baseline.

    6 months

Secondary Outcomes (1)

  • Improved overall cardiopulmonary variables

    1-6 months

Study Arms (1)

Remodulin

EXPERIMENTAL

Subcutaneous (SQ) remodulin will be initiated at 1.25 ng/kg/min, and increased by 2-6 ng/kg/min weekly to a target dose of 40 ng/kg/min. If the initial infusion rate cannot be tolerated it will be reduced to 0.625 ng/kg/min. If subjects cannot tolerate the SQ therapy, we will attempt to switch to IV therapy.

Drug: Remodulin

Interventions

RemodulinDRUG

Subcutaneous (SQ) remodulin will be initiated at 1.25 ng/kg/min, and increased by 2-6 ng/kg/min weekly to a target dose of 40 ng/kg/min. If the initial infusion rate cannot be tolerated it will be reduced to 0.625 ng/kg/min. If subjects cannot tolerate the SQ therapy, we will attempt to switch to IV therapy.

Also known as: treprostinil, tyvaso
Remodulin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Congenital heart disease with Pulmonary Arterial (PA) hypertension (repaired or unrepaired) defined as a mean resting directly measured Pulmonary Artery Pressure (PAP) of ≥35 mm Hg and/or doppler echo estimated PA systolic pressure ≥ 60 mm Hg.
  • Patients already on phosphodiesterase type 5 inhibitor (PDE-5), Endothelin Receptor Antagonist (ERA), or inhaled prostacyclin are not excluded

You may not qualify if:

  • Age \< 18 years
  • Current intravenous or subcutaneous prostacyclin therapy
  • Resting systemic hypotension (Systolic blood pressure \< 80 mm Hg)
  • Women who are pregnant or may become pregnant (unwilling to utilize effective contraception), as well as nursing mothers
  • Inability to ambulate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Ohio State University/Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (4)

  • Gomberg-Maitland M, Tapson VF, Benza RL, McLaughlin VV, Krichman A, Widlitz AC, Barst RJ. Transition from intravenous epoprostenol to intravenous treprostinil in pulmonary hypertension. Am J Respir Crit Care Med. 2005 Dec 15;172(12):1586-9. doi: 10.1164/rccm.200505-766OC. Epub 2005 Sep 8.

    PMID: 16151039BACKGROUND

  • Barst RJ, Galie N, Naeije R, Simonneau G, Jeffs R, Arneson C, Rubin LJ. Long-term outcome in pulmonary arterial hypertension patients treated with subcutaneous treprostinil. Eur Respir J. 2006 Dec;28(6):1195-203. doi: 10.1183/09031936.06.00044406. Epub 2006 Aug 9.

    PMID: 16899485BACKGROUND

  • Tapson VF, Gomberg-Maitland M, McLaughlin VV, Benza RL, Widlitz AC, Krichman A, Barst RJ. Safety and efficacy of IV treprostinil for pulmonary arterial hypertension: a prospective, multicenter, open-label, 12-week trial. Chest. 2006 Mar;129(3):683-8. doi: 10.1378/chest.129.3.683.

    PMID: 16537868BACKGROUND

  • Simonneau G, Barst RJ, Galie N, Naeije R, Rich S, Bourge RC, Keogh A, Oudiz R, Frost A, Blackburn SD, Crow JW, Rubin LJ; Treprostinil Study Group. Continuous subcutaneous infusion of treprostinil, a prostacyclin analogue, in patients with pulmonary arterial hypertension: a double-blind, randomized, placebo-controlled trial. Am J Respir Crit Care Med. 2002 Mar 15;165(6):800-4. doi: 10.1164/ajrccm.165.6.2106079.

    PMID: 11897647BACKGROUND

Related Links

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

treprostinil

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Jamil A Aboulhosn, MD

    UCLA Health System

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

September 24, 2013

First Posted

November 11, 2013

Study Start

November 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

September 21, 2017

Record last verified: 2017-09

Locations

US(2)