Baseline Characteristics of the VANISH Cohort.


Journal

Circulation. Heart failure
ISSN: 1941-3297
Titre abrégé: Circ Heart Fail
Pays: United States
ID NLM: 101479941

Informations de publication

Date de publication:
12 2019
Historique:
entrez: 10 12 2019
pubmed: 10 12 2019
medline: 17 6 2020
Statut: ppublish

Résumé

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. 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. In the primary cohort, maximal left ventricular wall thickness was 17±4 mm for adults and 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 URL: https://www.clinicaltrials.gov. Unique identifier: NCT01912534.

Sections du résumé

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

Identifiants

pubmed: 31813281
doi: 10.1161/CIRCHEARTFAILURE.119.006231
pmc: PMC7219518
mid: NIHMS1549522
doi:

Substances chimiques

Angiotensin II Type 1 Receptor Blockers 0
Valsartan 80M03YXJ7I

Banques de données

ClinicalTrials.gov
['NCT01912534']

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial Research Support, N.I.H., Extramural

Langues

eng

Sous-ensembles de citation

IM

Pagination

e006231

Subventions

Organisme : NHLBI NIH HHS
ID : P20 HL101408
Pays : United States
Organisme : NHLBI NIH HHS
ID : P50 HL112349
Pays : United States

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Auteurs

Anna Axelsson Raja (A)

Copenhagen University Hospital Rigshospitalet, Denmark (A.A.R., H.B.).

Ling Shi (L)

New England Research Institutes, Watertown, MA (L.S.).

Sharlene M Day (SM)

University of Michigan, Ann Arbor (S.M.D., M.R.).

Mark Russell (M)

University of Michigan, Ann Arbor (S.M.D., M.R.).

Kenneth Zahka (K)

Cleveland Clinic, OH (K.Z., H.L.).

Harry Lever (H)

Cleveland Clinic, OH (K.Z., H.L.).

Steven D Colan (SD)

Boston Children's Hospital, MA (S.D.C., R.M.).

Renee Margossian (R)

Boston Children's Hospital, MA (S.D.C., R.M.).

E Kevin Hall (EK)

Yale University, New Haven, CT (E.K.H.).

Jason Becker (J)

Vanderbilt University Medical Center, Nashville, TN (J.B.).

John Lynn Jefferies (JL)

Cincinnati Children's Hospital Medical Center, OH (J.L.J.).

Amit R Patel (AR)

University of Chicago, IL (A.R.P.).

Lubna Choudhury (L)

Northwestern University, Chicago, IL (L.C.).

Anne M Murphy (AM)

Johns Hopkins University School of Medicine, Baltimore, MD (A.M.M.).

Charles Canter (C)

Washington University School of Medicine, St. Louis, MO (C.C., R.B.).

Richard Bach (R)

Washington University School of Medicine, St. Louis, MO (C.C., R.B.).

Matthew Taylor (M)

University of Colorado Anschutz Medical Campus, Aurora (M.T., L.M.).

Luisa Mestroni (L)

University of Colorado Anschutz Medical Campus, Aurora (M.T., L.M.).

Matthew T Wheeler (MT)

Stanford University School of Medicine, Palo Alto, CA (M.T.W.).

Lee Benson (L)

Toronto Hospital for Sick Children, ON, Canada (L.B.).

Anjali T Owens (AT)

University of Pennsylvania Perelman School of Medicine, Philadelphia (A.T.O.).

Joseph Rossano (J)

Children's Hospital of Philadelphia, PA (J.R., K.Y.L.).

Kimberly Y Lin (KY)

Children's Hospital of Philadelphia, PA (J.R., K.Y.L.).

Elfriede Pahl (E)

Ann & Robert H. Lurie Children's Hospital of Chicago, IL (E.P.).

Alexandre C Pereira (AC)

Heart Institute, University of São Paulo Medical School (Instituto do Coração), Brazil (A.C.P.).

Henning Bundgaard (H)

Copenhagen University Hospital Rigshospitalet, Denmark (A.A.R., H.B.).

Gregory D Lewis (GD)

Massachusetts General Hospital, Boston (G.D.L.).

Jose D Vargas (JD)

MedStar Georgetown University Hospital, National Institutes of Health, Bethesda, MD (J.D.V.).

Allison L Cirino (AL)

Brigham and Women's Hospital, Boston, MA (A.L.C., C.A.M., S.D.S., E.J.O., E.B., C.Y.H.).

John J V McMurray (JJV)

University of Glasgow, Glasgow, UK (J.J.V.M.).

Calum A MacRae (CA)

Brigham and Women's Hospital, Boston, MA (A.L.C., C.A.M., S.D.S., E.J.O., E.B., C.Y.H.).

Scott D Solomon (SD)

Brigham and Women's Hospital, Boston, MA (A.L.C., C.A.M., S.D.S., E.J.O., E.B., C.Y.H.).

E John Orav (EJ)

Brigham and Women's Hospital, Boston, MA (A.L.C., C.A.M., S.D.S., E.J.O., E.B., C.Y.H.).

Eugene Braunwald (E)

Brigham and Women's Hospital, Boston, MA (A.L.C., C.A.M., S.D.S., E.J.O., E.B., C.Y.H.).

Carolyn Y Ho (CY)

Brigham and Women's Hospital, Boston, MA (A.L.C., C.A.M., S.D.S., E.J.O., E.B., C.Y.H.).

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Classifications MeSH