Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-01-12 @ 10:24 AM
Study NCT ID:
NCT03015402
Status:
COMPLETED
Last Update Posted:
2024-06-07
First Post:
2017-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction
Sponsor:
University of Pittsburgh
Organization:
Study Overview
Official Title:
Phase II Clinical Investigation of Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (PH-HFpEF)
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PH-HFpEF
Brief Summary:
The main objective of this study is to determine the clinical efficacy of oral inorganic nitrite verses placebo and the therapeutic response with regards to exercise tolerance in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF).
Detailed Description:
This is a single-center, 22-week double-blind, randomized placebo-controlled cross-over trial of oral nitrite on exercise capacity and hemodynamic measurements in subjects with PH-HFpEF.
Study Oversight
Has Oversight DMC:
True
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?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5P01HL103455 | NIH | None | https://reporter.nih.gov/quic… | View |