drugset / Trial / NCT01912534
Valsartan for Attenuating Disease Evolution In Early Sarcomeric HCM
Phase 2
Completed
211 enrolled
Carelon Research
National Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this trial is to determine whether treatment with valsartan will have beneficial effect in early hypertrophic cardiomyopathy (HCM) by assessing many domains that reflect myocardial structure, function and biochemistry.
Timeline
- Start
- 2014-03
- Primary completion
- 2019-07
- Completion
- 2019-07
Publications
- Topriceanu CC, Vissing CR, Axelsson Raja A, Day SM, Russell MW, Zahka K, Pereira AC, Colan SD, Murphy AM, Canter C, Bach RG, Wheeler MT, Rossano JW, Owens AT, Mestroni L, Taylor MRG, Moon JC, Captur G, Patel AR, Wilmot I, Soslow JH, Becker JR, Seidman CE, Lakdawala NK, Bundgaard H, Tahir UA, Ho CY. Proteomic Analysis of Valsartan for Attenuating Disease Evolution in Early Sarcomeric Hypertrophic Cardiomyopathy (VANISH) Clinical Trial. Circ Heart Fail. 2025 Jun;18(6):e012393. doi: 10.1161/CIRCHEARTFAILURE.124.012393. Epub 2025 May 9.
- Ostrominski JW, Claggett BL, Jerosch-Herold M, Raja AA, Day SM, Russell MW, Zahka K, Pereira AC, Colan SD, Murphy AM, Canter C, Bach RG, Wheeler MT, Rossano JW, Owens AT, Mestroni L, Taylor MRG, Patel AR, Wilmot I, Soslow JH, Becker JR, Lakdawala NK, Bundgaard H, Vargas JD, Ho CY; Valsartan for Attenuating Disease Evolution in Early Sarcomeric Hypertrophic Cardiomyopathy (VANISH) Investigators. Valsartan and Cardiac Remodeling in Early-Stage Hypertrophic Cardiomyopathy: The VANISH Randomized Clinical Trial Cardiac Magnetic Resonance Substudy. JAMA Cardiol. 2025 Jun 1;10(6):617-623. doi: 10.1001/jamacardio.2024.5677.
- Ireland CG, Burstein DS, Day SM, Axelsson Raja A, Russell MW, Zahka KG, Pereira A, Canter CE, Bach RG, Wheeler MT, Rossano JW, Owens AT, Bundgaard H, Mestroni L, Taylor MRG, Patel AR, Wilmot I, Soslow JH, Becker JR, Giverts I, Orav EJ, Claggett B, Lin KY, Ho CY. Quality of Life and Exercise Capacity in Early Stage and Subclinical Hypertrophic Cardiomyopathy: A Secondary Analysis of the VANISH Trial. Circ Heart Fail. 2024 Aug;17(8):e011663. doi: 10.1161/CIRCHEARTFAILURE.124.011663. Epub 2024 Aug 1.
- Vissing CR, Axelsson Raja A, Day SM, Russell MW, Zahka K, Lever HM, Pereira AC, Colan SD, Margossian R, Murphy AM, Canter C, Bach RG, Wheeler MT, Rossano JW, Owens AT, Benson L, Mestroni L, Taylor MRG, Patel AR, Wilmot I, Thrush P, Soslow JH, Becker JR, Seidman CE, Lakdawala NK, Cirino AL, McMurray JJV, MacRae CA, Solomon SD, Bundgaard H, Orav EJ, Ho CY; Valsartan for Attenuating Disease Evolution in Early Sarcomeric Hypertrophic Cardiomyopathy (VANISH) Investigators. Cardiac Remodeling in Subclinical Hypertrophic Cardiomyopathy: The VANISH Randomized Clinical Trial. JAMA Cardiol. 2023 Nov 1;8(11):1083-1088. doi: 10.1001/jamacardio.2023.2808.
- Ho CY, Day SM, Axelsson A, Russell MW, Zahka K, Lever HM, Pereira AC, Colan SD, Margossian R, Murphy AM, Canter C, Bach RG, Wheeler MT, Rossano JW, Owens AT, Bundgaard H, Benson L, Mestroni L, Taylor MRG, Patel AR, Wilmot I, Thrush P, Vargas JD, Soslow JH, Becker JR, Seidman CE, Lakdawala NK, Cirino AL; VANISH Investigators; Burns KM, McMurray JJV, MacRae CA, Solomon SD, Orav EJ, Braunwald E. Valsartan in early-stage hypertrophic cardiomyopathy: a randomized phase 2 trial. Nat Med. 2021 Oct;27(10):1818-1824. doi: 10.1038/s41591-021-01505-4. Epub 2021 Sep 23.
- Axelsson Raja A, Shi L, Day SM, Russell M, Zahka K, Lever H, Colan SD, Margossian R, Hall EK, Becker J, Jefferies JL, Patel AR, Choudhury L, Murphy AM, Canter C, Bach R, Taylor M, Mestroni L, Wheeler MT, Benson L, Owens AT, Rossano J, Lin KY, Pahl E, Pereira AC, Bundgaard H, Lewis GD, Vargas JD, Cirino AL, McMurray JJV, MacRae CA, Solomon SD, Orav EJ, Braunwald E, Ho CY. Baseline Characteristics of the VANISH Cohort. Circ Heart Fail. 2019 Dec;12(12):e006231. doi: 10.1161/CIRCHEARTFAILURE.119.006231. Epub 2019 Dec 9.
- Lee TM, Hsu DT, Kantor P, Towbin JA, Ware SM, Colan SD, Chung WK, Jefferies JL, Rossano JW, Castleberry CD, Addonizio LJ, Lal AK, Lamour JM, Miller EM, Thrush PT, Czachor JD, Razoky H, Hill A, Lipshultz SE. Pediatric Cardiomyopathies. Circ Res. 2017 Sep 15;121(7):855-873. doi: 10.1161/CIRCRESAHA.116.309386.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Valsartan | Small molecule | 80 mg | — |
| Comparator | Valsartan | Small molecule | 160 mg | — |
| Comparator | Valsartan | Small molecule | 320 mg | — |