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The Renin-Aldosterone Axis in Postural Tachycardia Syndrome
Plain-language guide to NCT00962949: phase 1 non-randomized trial of Angiotensin II, 28 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00962949
- Phase
- phase 1
- Status
- completed
- Start
- 2009-04
- Completion (planned or actual)
- 2012-12
- Participants
- 28 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), basic_science
- Conditions studied
- Postural Orthostatic Tachycardia Syndrome (POTS)
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Angiotensin II.
The purpose of this study is to determine the role of the renin-angiotensin-aldosterone in the pathophysiology of postural tachycardia syndrome, and to provide an insight about the disease process in this disorder.
It had two arms (groups): Control (experimental) and Postural Tachycardia Syndrome (experimental).
Healthy controls.
Patients with Postural Tachycardia Syndrome.
The registry classes the interventions as drug.
Who Took Part
The registry lists 28 actual participants took part.
It was open to people of any sex aged from 18 years up to 64 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Age between 18-64 years. Male or females are eligible. Able and willing to provide informed consent.
The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: overt cause of postural tachycardia e.g., dehydration; inability to give or withdraw informed consent; hypertension (bp \> 140/90).
How the Study Was Run
It was run as a non-randomized, parallel-group and open-label study.
The Angiotensin II group and the comparison group ran side by side rather than switching.
Everyone knew when Angiotensin II was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2009-04 with completion listed for 2012-12.
It ran at 1 site in United States.
Its stated primary purpose is basic science.
What Was Measured
Researchers chose this as the main measure: Mean Arterial Blood Pressure Change (time frame: 1 hour).
It also tracked 3 secondary outcomes, for example Plasma Renin Activity, Aldosterone Level and Cortisol Level.
What This Means in Plain Language
Put simply, this is a phase 1, non-randomized trial of Angiotensin II in 28 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Angiotensin II compound page, all human trials.
Our Notes on the Compound
Angiotensin II: An 8-amino-acid hormone that narrows blood vessels; synthetic angiotensin II (Giapreza) is used for low blood pressure in shock.
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.