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NCT02256345 · ClinicalTrials.gov registry record · Phase 2
Pharmacokinetics, Pharmacodynamics, and Impact of Inorganic Nitrate on Exercise in HFpEF
A Phase 2 study of Heart Failure and Diastolic Heart Failure, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT02256345: Completed Phase 2 study of Heart Failure and Diastolic Heart Failure, sponsored by University of Pennsylvania.
NCT02256345 is a Phase 2 study of Heart Failure and Diastolic Heart Failure that has completed, run by University of Pennsylvania. The registered enrollment target is 12 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
NCT02256345, a Phase 2 study of Heart Failure and Diastolic Heart Failure, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will be performed to determine the safety, tolerability, and dose-response to inorganic nitrate on exercise capacity in HFpEF. There are two primary goals for this study: 1. Determine the population-specific pharmacokinetics and dose of KNO3 that can be safely given to subjects with HFpEF. 2. Determine if there is a dose-response effect of nitrate supplementation on exercise capacity, evidenced by peak oxygen consumption (peak VO2), and physiologic adaptations to exercise.
Primary Outcome
Peak oxygen uptake (VO2) defined as the average value obtained during the last 30 seconds of exercise.
Conditions Studied
Interventions
- DRUG KNO3
- DRUG KCl
Study Locations (1)
Pennsylvania
- Hospital of the University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2015-01 |
| Est. Completion | 2016-06 |
| Phase | Phase 2 |
What the finished NCT02256345 record still lists
NCT02256345 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 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 2 conditions, with Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which KNO3 is the first listed.
NCT02256345 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02256345 about?
NCT02256345 is a clinical study titled "Pharmacokinetics, Pharmacodynamics, and Impact of Inorganic Nitrate on Exercise in HFpEF". This study will be performed to determine the safety, tolerability, and dose-response to inorganic nitrate on exercise capacity in HFpEF. There are two primary goals for this study: 1. Determine the population-specific pharmacokinetics and dose of KNO3 that can be safely given to subjects with HFpE...
What is the current status of trial NCT02256345?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2015-01. Estimated completion is 2016-06.
What conditions does trial NCT02256345 study?
This clinical trial studies the following conditions: Heart Failure, Diastolic Heart Failure.
What interventions are being tested in trial NCT02256345?
The interventions under investigation include: KNO3 (DRUG), KCl (DRUG).
Who is sponsoring clinical trial NCT02256345?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02256345 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 NCT02256345's enrollment target sits among peer trials
12 379th of 397 higher than 18 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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