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NCT02457260 · ClinicalTrials.gov registry record · Phase 2
Oral Nitrite for Older Heart Failure Patients
A Phase 2 study of Heart Failure, sponsored by Gladwin, Mark, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT02457260: Completed Phase 2 study of Heart Failure, sponsored by Gladwin, Mark, MD.
NCT02457260 is a Phase 2 study of Heart Failure that has completed, run by Gladwin, Mark, MD. The registered enrollment target is 21 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02457260, a Phase 2 study of Heart Failure, has completed, sponsored by Gladwin, Mark, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
Studies have demonstrated nitrite therapy increases adenosine triphosphate (ATP) synthesis in skeletal muscle mitochondria concomitant with reduced whole-body oxygen cost during steady state exercise. Our own work has demonstrated safety and efficacy of an FDA investigational new drug (IND) approved sodium nitrite (10 milligram \[mg\]) capsule, and its utility to upregulate the sirtuin 3 adenosine monophosphate protein kinase (SIRT3-AMP) pathway of skeletal muscle of younger heart failure (HF) patients. It now seems exceptionally logical and opportune to apply these insights to older HF patients and to delineate mechanisms of disease and aging that respond to nitrite therapy.
Primary Outcome
Obtained via analysis of skeletal muscle biopsy of the vastus lateralis, Polymerase chain reaction (PCR) to assess pertinent gene expression within the pathways of ubiquitin \[muscle ring finger protein 1 (MuRF), Atrogin1, Forkhead Box 03 (FoxO)\], additionally Fibronectin type III domain-containing protein 5, the precursor of irisin (FNDC5), Peroxisome proliferator-activated receptor gamma co activator 1-alpha (PGC1α), and Sirtuin 3 were assessed.
Conditions Studied
Interventions
- DRUG 14 N Sodium Nitrite
Study Locations (1)
Pennsylvania
- UPMC Montefiore Hospital - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2016-01-08 |
| Est. Completion | 2017-03-06 |
| Phase | Phase 2 |
What the finished NCT02457260 record still lists
NCT02457260 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which 14 N Sodium Nitrite is the first listed.
NCT02457260 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02457260 about?
NCT02457260 is a clinical study titled "Oral Nitrite for Older Heart Failure Patients". Studies have demonstrated nitrite therapy increases adenosine triphosphate (ATP) synthesis in skeletal muscle mitochondria concomitant with reduced whole-body oxygen cost during steady state exercise. Our own work has demonstrated safety and efficacy of an FDA investigational new drug (IND) approved...
What is the current status of trial NCT02457260?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2016-01-08. Estimated completion is 2017-03-06.
What conditions does trial NCT02457260 study?
This clinical trial studies the following conditions: Heart Failure.
What interventions are being tested in trial NCT02457260?
The interventions under investigation include: 14 N Sodium Nitrite (DRUG).
Who is sponsoring clinical trial NCT02457260?
This trial is sponsored by Gladwin, Mark, MD, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02457260 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02457260's enrollment target sits among peer trials
21 344th of 397 higher than 49 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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