Baseline Characteristics of the VANISH Cohort.

MedStar author(s):
Citation: Circulation: Heart Failure. 12(12):e006231, 2019 12.PMID: 31813281Institution: MedStar Health Research InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Angiotensin II Type 1 Receptor Blockers/tu [Therapeutic Use] | *Cardiomyopathy, Hypertrophic/dt [Drug Therapy] | *Mutation | *Sarcomeres/ge [Genetics] | *Valsartan/tu [Therapeutic Use] | Adolescent | Adult | Angiotensin II Type 1 Receptor Blockers/ae [Adverse Effects] | Brazil | Canada | Cardiomyopathy, Hypertrophic/di [Diagnosis] | Cardiomyopathy, Hypertrophic/ge [Genetics] | Cardiomyopathy, Hypertrophic/pp [Physiopathology] | Child | Denmark | Disease Progression | Double-Blind Method | Female | Genetic Predisposition to Disease | Humans | Male | Middle Aged | Phenotype | Recovery of Function | Time Factors | Treatment Outcome | United States | Valsartan/ae [Adverse Effects] | Young AdultYear: 2019Local holdings: Available online from MWHC library: 2008 - presentISSN:
  • 1941-3289
Name of journal: Circulation. Heart failureAbstract: BACKGROUND: The VANISH trial (Valsartan for Attenuating Disease Evolution in Early Sarcomeric Hypertrophic Cardiomyopathy) targeted young sarcomeric gene mutation carriers with early-stage hypertrophic cardiomyopathy (HCM) to test whether valsartan can modify disease progression. We describe the baseline characteristics of the VANISH cohort and compare to previous trials evaluating angiotensin receptor blockers.CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01912534.CONCLUSIONS: The VANISH cohort is much larger, younger, less heterogeneous, and has less advanced disease than prior angiotensin receptor blocker trials in HCM. Participants had relatively normal functional capacity and mild HCM features. New York Heart Association functional class II symptoms were associated with older age, more prominent imaging abnormalities, and MYH7 variants, suggesting both phenotype and genotype contribute to disease manifestations.METHODS: Applying a randomized, double-blinded, placebo-controlled design, 178 participants with nonobstructive HCM (age, 23.3+/-10.1 years; 61% men) were randomized in the primary cohort and 34 (age, 16.5+/-4.9 years; 50% men) in the exploratory cohort of sarcomeric mutation carriers without left ventricular hypertrophy.RESULTS: In the primary cohort, maximal left ventricular wall thickness was 17+/-4 mm for adults and Z score 7.0+/-4.5 for children. Nineteen percent had late gadolinium enhancement on cardiac magnetic resonance. Mean peak oxygen consumption was 33 mL/kg per minute, and 92% of participants were New York Heart Association functional class I. New York Heart Association class II was associated with older age, MYH7 variants, and more prominent imaging abnormalities. Six previous trials of angiotensin receptor blockers in HCM enrolled a median of 24 patients (range, 19-133) with mean age of 51.2 years; 42% of patients were in New York Heart Association class >=II, and sarcomeric mutations were not required.All authors: Axelsson Raja A, Bach R, Becker J, Benson L, Braunwald E, Bundgaard H, Canter C, Choudhury L, Cirino AL, Colan SD, Day SM, Hall EK, Ho CY, Jefferies JL, Lever H, Lewis GD, Lin KY, MacRae CA, Margossian R, McMurray JJV, Mestroni L, Murphy AM, Orav EJ, Owens AT, Pahl E, Patel AR, Pereira AC, Rossano J, Russell M, Shi L, Solomon SD, Taylor M, Vargas JD, Wheeler MT, Zahka KOriginally published: Circulation: Heart Failure. 12(12):e006231, 2019 Dec.Fiscal year: FY2020Digital Object Identifier: Date added to catalog: 2020-01-03
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 31813281 Available 31813281

Available online from MWHC library: 2008 - present

BACKGROUND: The VANISH trial (Valsartan for Attenuating Disease Evolution in Early Sarcomeric Hypertrophic Cardiomyopathy) targeted young sarcomeric gene mutation carriers with early-stage hypertrophic cardiomyopathy (HCM) to test whether valsartan can modify disease progression. We describe the baseline characteristics of the VANISH cohort and compare to previous trials evaluating angiotensin receptor blockers.

CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01912534.

CONCLUSIONS: The VANISH cohort is much larger, younger, less heterogeneous, and has less advanced disease than prior angiotensin receptor blocker trials in HCM. Participants had relatively normal functional capacity and mild HCM features. New York Heart Association functional class II symptoms were associated with older age, more prominent imaging abnormalities, and MYH7 variants, suggesting both phenotype and genotype contribute to disease manifestations.

METHODS: Applying a randomized, double-blinded, placebo-controlled design, 178 participants with nonobstructive HCM (age, 23.3+/-10.1 years; 61% men) were randomized in the primary cohort and 34 (age, 16.5+/-4.9 years; 50% men) in the exploratory cohort of sarcomeric mutation carriers without left ventricular hypertrophy.

RESULTS: In the primary cohort, maximal left ventricular wall thickness was 17+/-4 mm for adults and Z score 7.0+/-4.5 for children. Nineteen percent had late gadolinium enhancement on cardiac magnetic resonance. Mean peak oxygen consumption was 33 mL/kg per minute, and 92% of participants were New York Heart Association functional class I. New York Heart Association class II was associated with older age, MYH7 variants, and more prominent imaging abnormalities. Six previous trials of angiotensin receptor blockers in HCM enrolled a median of 24 patients (range, 19-133) with mean age of 51.2 years; 42% of patients were in New York Heart Association class >=II, and sarcomeric mutations were not required.

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