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Effect of Urocortins in Patients With Heart Failure
Plain-language guide to NCT01599728: not phased non-randomized trial of Urocortin and Substance P, 22 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01599728
- Phase
- not phased
- Status
- completed
- Start
- 2012-05
- Completion (planned or actual)
- 2012-07
- Participants
- 22 (actual)
- Design
- non-randomized, single-blind, basic_science
- Conditions studied
- Heart Failure; Endothelium
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test Urocortin and Substance P.
Despite modern advances in treatment, heart failure continues to carry a poor prognosis with high morbidity and mortality rates.
Hence, there remains a major interest in the development of novel therapeutic agents for this debilitating condition.
Urocortins have recently shot into limelight with their potential role in the pathophysiology and treatment of heart failure.
It had two arms (groups): Patients with heart failure (other) and Healthy controls (other).
Assessing the response to infusion of intra-arterial Urocortin 2, 3 and Substance P in patients with heart failure.
Assessing response to intra-arterial infusions of Urocortin 2, 3 and Substance P in age and sex-matched healthy volunteers as controls.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 22 actual participants took part.
It was open to people of any sex aged from 18 years up to 80 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Age 18-80 years (inclusive) at recruitment. Age and sex-matched healthy volunteers.
The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: lack of informed consent; age \<18 years and \> 80 years; current involvement in a clinical trial.
How the Study Was Run
Design: non-randomized, parallel-group and single-blind.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Only one side, usually the participants, was kept unaware of whether Urocortin was given.
Those kept unaware of assignments: participant.
It started in 2012-05 with completion listed for 2012-07.
It ran at 1 site in United Kingdom.
Its stated primary purpose is basic science.
What Was Measured
The main thing measured (primary outcome): Forearm blood flow (time frame: 3 hours).
It also tracked 1 secondary outcome, for example Absolute forearm blood flow.
What This Means in Plain Language
Put simply, this is a not phased, non-randomized trial of Urocortin and Substance P in 22 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Urocortin compound page and the Substance P compound page, all human trials.
Our Notes on the Compounds
Urocortin: A family of peptides related to CRH that act on the heart and stress-response system; studied in heart failure trials.
Substance P: An 11-amino-acid neuropeptide involved in pain signaling and inflammation; given in research studies.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.