Characteristics of the Valheft (Valsartan in Heart Failure Trial) Population
The Valheft trial primarily enrolled patients with NYHA class II-IV heart failure with reduced ejection fraction (LVEF <40%) who were predominantly male (80%), Caucasian (90%), with a mean age of 63 years. 1
Key Demographics
- Age: Mean age of 62.7 years 1
- Gender: 80% male, 20% female 1
- Race: 90.3% white, 6.9% black, 2.8% Asian 1
- NYHA Classification:
- Class II: 62% of patients
- Class III-IV: 38% of patients (with only 2% being class IV) 2
- Ejection Fraction: All patients had LVEF <40% (mean 25%) 3
Underlying Conditions
- Etiology: 57.2% had coronary heart disease as the underlying cause 1
- Comorbidities: The trial included patients with various comorbidities typical of heart failure populations
Baseline Medications
The trial included patients on standard heart failure therapy:
- ACE inhibitors: 92.7% of patients
- Diuretics: 85.8% of patients
- Digoxin: 67.3% of patients
- Beta-blockers: 35.6% of patients 1
Key Exclusion/Inclusion Criteria
The trial enrolled patients with:
- Symptomatic heart failure (NYHA class II-IV)
- LVEF <40%
- Stable on standard heart failure medications
Study Design Considerations
The Val-HeFT trial was designed to evaluate the effects of adding valsartan to standard heart failure therapy. It's important to note that:
- The study included a significant proportion of patients (92.7%) already on ACE inhibitors 1
- Only 7.3% of patients were not receiving ACE inhibitors at baseline 4
- A post-hoc analysis showed that valsartan had different effects depending on baseline medications:
- Beneficial in patients not receiving ACE inhibitors
- Potentially adverse effects in patients receiving both ACE inhibitors and beta-blockers 2
Clinical Outcomes
While not directly part of the population characteristics, it's worth noting that:
- Overall mortality was similar between valsartan and placebo groups
- The combined endpoint of mortality and morbidity was 13.2% lower with valsartan than placebo
- Hospitalization for heart failure was significantly reduced in the valsartan group (13.8% vs 18.2% in placebo) 2
Practical Implications
Understanding the Val-HeFT population is crucial because:
- The benefits of valsartan were most pronounced in patients not receiving ACE inhibitors
- This has informed current guidelines that recommend ARBs like valsartan as alternatives to ACE inhibitors in patients who are intolerant to ACE inhibitors 5
- The trial provided evidence for the FDA approval of valsartan for heart failure patients who cannot tolerate ACE inhibitors 6