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The Design of the Valsartan for Attenuating Disease Evolution in Early Sarcomeric Hypertrophic Cardiomyopathy

Carolyn Y Ho1, John J V McMurray2, Allison L Cirino1

  • 1Brigham and Women's Hospital, Boston, MA, USA.

American Heart Journal
|April 30, 2017
PubMed

Insights

The VANISH trial investigates valsartan for early-stage hypertrophic cardiomyopathy (HCM) in gene mutation carriers. This study assesses if angiotensin receptor blockers (ARBs) can modify disease progression in young patients, potentially preventing left ventricular hypertrophy (LVH).

Area of Science:

  • Cardiology
  • Genetics
  • Pharmacology

Background:

  • Hypertrophic cardiomyopathy (HCM) is frequently caused by sarcomere gene mutations, leading to left ventricular hypertrophy (LVH), fibrosis, and increased risk of sudden cardiac death.
  • Animal models suggest early intervention with angiotensin receptor blockers (ARBs) can mitigate LVH and fibrosis in sarcomeric HCM.
  • Previous human trials have used ARBs in heterogeneous adult HCM populations with established disease, limiting understanding of early intervention effects.

Purpose of the Study:

  • To evaluate the safety and feasibility of disease-modifying therapy using an ARB in genotyped HCM patients with early-stage disease or at risk.
  • To test valsartan's efficacy in preventing or reducing the progression of left ventricular hypertrophy (LVH) and myocardial fibrosis in young sarcomere mutation carriers.

Main Methods:

  • A randomized, placebo-controlled, double-blind clinical trial (VANISH trial) involving sarcomere mutation carriers aged 8 to 45 years with early or no/minimal HCM symptoms.
  • Participants receive daily valsartan (80-320 mg) or placebo, with dosage adjusted for age and weight.
  • The primary endpoint is a composite of 9 z-scores assessing myocardial injury, hemodynamic stress, cardiac morphology, and function changes from baseline.

Main Results:

  • The VANISH trial is ongoing; results are not yet available.
  • Analysis will compare composite z-score changes between valsartan and placebo groups.
  • Secondary endpoints will examine treatment effects in mutation carriers without LVH and explore influences of age, sex, and genotype.

Conclusions:

  • The VANISH trial represents a novel strategy for disease modification in early-stage and at-risk HCM patients.
  • Findings are expected to provide insights into HCM disease mechanisms, therapeutic responses, and phenotypic evolution.
  • This study aims to establish ARBs as a potential early intervention for sarcomeric HCM.

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