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Evaluation of the Effects of Carperitide in Patients With Congestive Heart Failure
Plain-language guide to NCT00259038: phase 2 randomized trial of ANP (Atrial Natriuretic Peptide), 162 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00259038
- Phase
- phase 2
- Status
- completed
- Start
- 2004-01
- Completion (planned or actual)
- 2006-02
- Participants
- 162 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Heart Failure, Congestive; Heart Decompensation; Left Ventricular Failure; Myocardiopathies; Systolic or Diastolic Left Ventricular Dysfunction
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around ANP (Atrial Natriuretic Peptide).
It had two arms (groups): Experimental Drug (experimental) and Placebo (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 162 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Is hospitalized with congestive heart failure (CHF). Has a Swan-Ganz catheter inserted for CHF management and has pulmonary capillary wedge pressure 18 mmHg or higher.
The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: has had a heart transplant; requires mechanical ventilation or mechanical circulatory support.
How the Study Was Run
Design: randomized, parallel-group and double-blind.
The participants were allocated by chance, so the ANP (Atrial Natriuretic Peptide) group and the comparison group should start out alike.
The ANP (Atrial Natriuretic Peptide) group and the comparison group ran side by side rather than switching.
As a double-blind ANP (Atrial Natriuretic Peptide) study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant and investigator.
It started in 2004-01 with completion listed for 2006-02.
It ran at 34 sites in United States (30) and Canada (4).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Change from baseline in pulmonary capillary wedge pressure (PCWP) (time frame: at 3 hours following initiation of study drug infusion).
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of ANP (Atrial Natriuretic Peptide) in 162 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the ANP (Atrial Natriuretic Peptide) compound page, all human trials.
Our Notes on the Compound
ANP (Atrial Natriuretic Peptide): A 28-amino-acid heart hormone that relaxes blood vessels and increases salt excretion; carperitide is a recombinant form.
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.