SOLVD Trial (asymptomatic CHF Class II and III Patients')

BRIEF SUMMARY:

Here is the brief summary:

Name: SOLVD

Specialty: Cardiology, Congestive Heart Failure. 

Problem: Heart failure (Asymptomatic - unlike CONSENSUS which involved only NYHA class IV symptomatic patients)

Population: 4228 patients (2111 took Enalapril and 2117 Placebo)


Inclusion criteria:
Patients with congestive heart failure and ejection fractions of < 35% (0.35 or less) who were already taking drugs other than an angiotensin-converting—enzyme inhibitor as part of conventional therapy for congestive heart failure were eligible for the study. 
At that time only therapy most of these people were on was a diuretic and digoxin.(so less than 1/4th on B-Blockers)
  Exclusion criteria:
Use of an angiotensin-converting—enzyme inhibitor (28 percent)
Cardiovascular problems (12 percent)
Contraindications to the use of an angiotensin-converting—enzyme inhibitor (11 percent)
Lack of consent by the patient (11 percent)
Administrative reasons (21 percent)
Cancer or other life-threatening disease (12 percent)
Other reasons (5 percent).
Intervention: Enalapril
Control: Placebo
Follow-up: Mean 37.4 months

Primary endpoint:
Mortality
Combined end point of death or hospitalizations
Secondary endpoint(s):
None
Details:

Enalapril vs placebo (in addition to diuretics, nitrates & digoxin for specific indications only)


Brief Results:
Reduced deaths by all causes in Enalapril group by 8 percent. (statistically not significant)
Reduced cardiovascular death in Enalapril group by 12 percent. (statistically not significant)
Combined endpoint of TOTAL DEATHS + NEW HEART FAILURE DEVELOPEMENT  was lower in Enalapril group by 29 percent.
Reduced hospitalizations in Enalapril group when compared to placebo group. (by 20 percent)

Original Paper

Effect of enalapril on mortality and the development of heart failure in asymptomatic patients with reduced left ventricular ejection fractions.

3 Sep 1992 N Engl J Med. 1992 Sep 3;327(10):685-91. :
-Significantly reduced Incidence of heart failure
-Hospital admissions for heart failure
Trend towards fewer deaths


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DETAILED ANALYSIS OF THE PAPER 

What does SOLVD stand for?

Studies Of Left Ventricular Dysfunction.

 What is so special about this trial?

This was one of the first trials showing improvement in incidence of heart failure hospitalizations in asymptomatic patients' with heart failure treated with Enalapril. (ACEI)

What is this trial all about?

This trial looked at use of ACEI enalapril at doses between 2.5 mg to 20 mg daily in 2111 asymptomatic heart failure patients. Unlike CONSENSUS trial which looked at NYHA class IV patients only.

What was the trial design?

Trial compared Enalapril (2111) to Placebo (2117) in patients with asymptomatic heart failure. Patients were not supposed to be on other HF therapy. However digoxin, diuretics and nitrates were allowed for specific instances. (very few people were on beta blockers)

What were the main findings?

Follow-up averaged 37.4 months.


Reduced deaths by all causes in Enalapril group by 8 percent. (statistically not significant).

Reduced cardiovascular death in Enalapril group by 12 percent. (statistically not significant).

Combined endpoint of TOTAL DEATHS + NEW HEART FAILURE DEVELOPEMENT  was lower in Enalapril group by 29 percent.

Reduced hospitalizations in Enalapril group when compared to placebo group. (by 20 percent)

Were there any specific advantages observed in using Enalapril?

Yes just like CONSENSUS trial, a significant improvement in NYHA classification was observed in the enalapril group, together with a reduction in heart size and a reduced requirement for other medication for heart failure.

Where and when was this trial published? and how can I obtain a copy of official pdf?

here is the link - 3 Sep 1992 N Engl J Med. 1992 Sep 3;327(10):685-91.

Anything else I need to know?

Well unlike CONSENSUS trial this trial recruited people from 23 countries including significant proportion from USA.

Anything unique to this trial?


Well only around 23.7% (Enalapril) to 24.3% in placebo were on beta blockers.

More thn 70 percent were neither on diuretics or digoxin.

Significant proportion had history of MI and IHD. (assumption would be that there were good number of patients with ischemic cardiomyopathy).


When and where was the trial published?

3rd September 1992 N Engl J Med. 1992 Sep 3;327(10):685-91 
(CLICK THE LINK ABOVE FOR PUBMED ABSTRACT).