Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-03-01 @ 8:54 PM
Study NCT ID:
NCT02304705
Status:
TERMINATED
Last Update Posted:
2019-11-07
First Post:
2014-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sildenafil in Heart Failure With Reactive Pulmonary Hypertension
Sponsor:
Maya Guglin
Organization:
Study Overview
Official Title:
Sildenafil in Heart Failure With Reactive Pulmonary Hypertension
Status:
TERMINATED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty meeting enrollment goal
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Sildenafil-HF
Brief Summary:
The purpose of this study is to determine whether Sildenafil 20mg taken three times a day is effective in the treatment of Heart Failure with Reactive Pulmonary Hypertension. This is a double-blind, placebo controlled trial.
Detailed Description:
Patients will be screened at the time of a diagnositic Right Heart Catheterization. Patients will be selected based on pressures measured during this procedure, current medications, and current symptoms. At baseline a 6 minute walk test and quality of life questionnaire will be administered. Medical records will be reviewed and results of recent testing will be recorded. Qualifying participants will be randomized to receive 90 days of either placebo or sildenafil 20 mg three times a day. Randomized patients will be followed for safety and efficacy by phone and as otherwise clinically indicated.
At the end of the 90 day treatment period, patients will be evaluated via 6 minute walk, quality of life questionnaire, and other diagnostic tests as clinically indicated. Primary outcome will be change in the 6 minute walk distance. Secondary outcomes will be based on clinically available results such as change in heart pressures measured by right heart catheterization and echocardiogram.
At the end of the treatment period, providers and patients will be unblinded in order to optimize further treatment.
To achieve statistical significance, 64 patients will be enrolled and randomized.
At the end of the 90 day treatment period, patients will be evaluated via 6 minute walk, quality of life questionnaire, and other diagnostic tests as clinically indicated. Primary outcome will be change in the 6 minute walk distance. Secondary outcomes will be based on clinically available results such as change in heart pressures measured by right heart catheterization and echocardiogram.
At the end of the treatment period, providers and patients will be unblinded in order to optimize further treatment.
To achieve statistical significance, 64 patients will be enrolled and randomized.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: