Ignite Creation Date:
2024-05-06 @ 3:19 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02253394
Status:
TERMINATED
Last Update Posted:
2019-11-15
First Post:
2014-09-17
Brief Title:
The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study The CAPS-PAH Study
Status:
TERMINATED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to find out if spironolactone added to ambrisentan for Pulmonary Arterial Hypertension PAH will increase exercise capacity We also want to find out if spironolactone and ambrisentan effect the cardiac output amount of blood the heart pumps every minute right ventricle function and quality of life
Detailed Description:
A prospective double blind placebo-controlled clinical study involving 30 patients with World Health Organization WHO Group 1 pulmonary arterial hypertension being treated with ambrisentan randomized to receive placebo or spironolactone 50 mgd for 90 days using a cross-over trial design
Eligible participants will be randomized to receive placebo or spironolactone 50 mgd for 90 days Phase I At the completion of Phase I participants will undergo repeat end-point assessment followed by a 21-day drug washout period Then the 90 day crossover phase of the trial will occur Phase II in which participants randomized to placebo in Phase I will be treated with spironolactone 50 mgd in Phase II and vice versa At the conclusion of Phase II end-point measures are reassessed
Spironolactone is a diuretic used in treatment of PAH patients Spironolactone is usually added to medical treatment when doses of LasixTorsemide are increased and patients are at risk for hypokalemia
Study procedures being done for this research study are the standard procedures performed on all PAH patients when they are in clinic for follow-up except for the Cardiopulmonary Exercise Test CPET with Innocor
Eligible participants will be randomized to receive placebo or spironolactone 50 mgd for 90 days Phase I At the completion of Phase I participants will undergo repeat end-point assessment followed by a 21-day drug washout period Then the 90 day crossover phase of the trial will occur Phase II in which participants randomized to placebo in Phase I will be treated with spironolactone 50 mgd in Phase II and vice versa At the conclusion of Phase II end-point measures are reassessed
Spironolactone is a diuretic used in treatment of PAH patients Spironolactone is usually added to medical treatment when doses of LasixTorsemide are increased and patients are at risk for hypokalemia
Study procedures being done for this research study are the standard procedures performed on all PAH patients when they are in clinic for follow-up except for the Cardiopulmonary Exercise Test CPET with Innocor
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None