Combination neurohormonal blockade with ACE inhibitors, angiotensin II antagonists and beta-blockers in patients with congestive heart failure: design of the Randomized Evaluation of Strategies for Left Ventricular Dysfunction (RESOLVD) Pilot Study

What Was Tested

This randomized controlled trial paper looks at Angiotensin II.

Secondary objectives are to determine the effect of the above combinations on neurohormones, ventricular function, quality of life and symptoms.

Stage II objectives are similar, evaluating the effect of the addition of metoprolol or placebo to the above medication(s).

Why It Was Studied

The Randomized Evaluation of Strategies for Left Ventricular Dysfunction (RESOLVD) Pilot Study is a trial of combination neurohormonal blockade using an angiotensin II antagonist (candesartan), an angiotensin-converting enzyme inhibitor (enalapril) and a beta-blocker (metoprolol) in patients with congestive heart failure (CHF).

Who Took Part

According to the abstract, 770 patients were involved.

Sixty out-patient clinics in five countries.

In stage I, 770 patients are randomized to receive candesartan alone, enalapril alone, or candesartan plus enalapril.

How the Study Was Run

The researchers set it up as a randomized, placebo-controlled and pilot study.

Random assignment meant chance, not the researchers, decided who got Angiotensin II and who got the comparison, which limits bias.

Some patients received a placebo instead of Angiotensin II, giving a reference point.

It is described as a pilot, a small early test of whether a larger Angiotensin II study would be practical.

Randomized, two-stage trial consisting of a three-way comparison (stage I), followed by a 3 x 2 partial factorial design (stage II).

After five months (end of stage I), patients are assessed for eligibility to be randomized in stage II.

Those who are not candidates for randomization to beta-blocker or placebo are followed on their stage I medications until the end of the study.

In stage II, patients are randomized to receive metoprolol or placebo for a further six months in addition to their stage I medications.

Endpoints are measured at baseline, end of stage I (week 20) and end of stage II (week 46).

What Was Measured

The Randomized Evaluation of Strategies for Left Ventricular Dysfunction (RESOLVD) Pilot Study is a trial of combination neurohormonal blockade using an angiotensin II antagonist (candesartan), an angiotensin-converting enzyme inhibitor (enalapril) and a beta-blocker (metoprolol) in patients with congestive heart failure (CHF).

The subject headings attached to it are Adrenergic beta-Antagonists, Angiotensin II, Angiotensin-Converting Enzyme Inhibitors, Heart Failure, Pilot Projects, Renin-Angiotensin System and Ventricular Dysfunction, Left.

What This Means in Plain Language

The paper is a randomized, placebo-controlled and pilot study of Angiotensin II in 770 patients.

With several hundred people or more, it is a fairly large study for this kind of research.

The publication is from 1997 (The Canadian journal of cardiology), a journal based in England.

More context: the Angiotensin II compound page, all human trials.