NCT00240656

Brief Summary

The purpose of this study is to determine whether a larger dose of the aldosterone antagonist spironolactone combined with an ACE inhibitor (captopril) and a beta-blocker (carvedilol) is effective in reverse pulmonary artery remodeling in patients with pulmonary arterial hypertension (PAH)secondary to congenital heart disease

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Oct 2005

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

June 30, 2008

Status Verified

October 1, 2005

First QC Date

October 17, 2005

Last Update Submit

June 27, 2008

Conditions

Hypertension, Pulmonary

Keywords

aldosterone antagonists, spironolactone, captopril carvedilol

Outcome Measures

Primary Outcomes (6)

  • Dyspnoea score

  • Exercise capacity (six-minute walk)

  • NYHA/WHO functional class

  • Change of acropachy

  • Blood gas test

  • Pulmonary artery pressure (measured by echocardiogram or catheter)

Secondary Outcomes (12)

  • Other echocardiographic changes:

  • Systolic pulmonary arterial pressure

  • Change of right to left shunt expressed by time-velocity integral (TVI) from the defect

  • Change of left to right shunt expressed by TVI from the defect

  • Right ventricular (RV) acceleration time (ms)

  • +7 more secondary outcomes

Interventions

spironolactone captopril carvedilolDRUG

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • A mean pulmonary artery pressure higher than 25 mm Hg or, when estimated by echocardiography, pulmonary artery pressure more than half the systemic artery pressure
  • Congenital systemic-to-pulmonary shunts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050031, China

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Kunshen Liu, M.D.

    The First Hospital of Hebei Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 17, 2005

First Posted

October 18, 2005

Study Start

October 1, 2005

Study Completion

May 1, 2006

Last Updated

June 30, 2008

Record last verified: 2005-10

Locations

CN(1)