Rationale for use of an exercise end point and design for the ADVANCE (A Dose evaluation of a Vasopressin ANtagonist in CHF patients undergoing Exercise) trial.

What Was Tested

This randomized controlled trial looks at Vasopressin.

Exercise testing is therefore widely used to evaluate the degree of functional impairment, prognosis of underlying cardiac disease, and response to treatment.

The purpose of this study was to outline the methodology and rationale of a unique cardiopulmonary exercise trial.

Why It Was Studied

Exercise intolerance is a primary characteristic of chronic congestive heart failure.

Who Took Part

PubMed indexes the participants as adults, middle-aged adults, older adults and people over 80, both men and women.

How the Study Was Run

The researchers set it up as a randomized, double-blind, placebo-controlled and multicenter study.

Because people in this Vasopressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Neither the participants nor the staff measuring them knew who was on Vasopressin, so expectations could not easily colour the readings.

The comparison arm used a placebo, so changes seen with Vasopressin could be set against what happens without it.

More than one site took part, so the participants came from several places.

The design was based on prior experience from evaluation of ACE inhibitors and other interventions.

What Was Measured

Exercise intolerance is a primary characteristic of chronic congestive heart failure.

PubMed files the paper under topics including Antidiuretic Hormone Receptor Antagonists, Benzazepines, Exercise Test, Heart Failure, Oxygen Consumption, Pulmonary Gas Exchange and Randomized Controlled Trials as Topic.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Vasopressin.

Its findings take up roughly 4 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2003 (American heart journal), a journal based in United States.

More context: the Vasopressin compound page, all human trials.