drugset / Trial / NCT00512759
Goal-directed Afterload Reduction in Acute Congestive Cardiac Decompensation Study
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine whether an early goal-directed decrement of preload and afterload with a target systolic blood pressure of 90-110 mmHg by aggressive vasodilatation in patients with acute HF in the non-ICU setting is safe, and leads to a better clinical and economical outcome
Timeline
- Start
- 2007-12-10
- Primary completion
- 2018-08-24
- Completion
- 2019-02-21
Outcome
Missed primary endpoint
paper absolute difference for the primary end point, 2.8% [95% CI, -3.7% to 9.3%]; adjusted hazard ratio, 1.07 [95% CI, 0.83-1.39]; P = .59). PMID 31846016 ↗
paper did not significantly improve a composite outcome of all-cause mortality and AHF rehospitalization at 180 days. PMID 31846016 ↗
Publications
- Wussler D, Belkin M, Maeder MT, Walter J, Shrestha S, Kupska K, Stierli M, Flores D, Kozhuharov N, Gualandro DM, de Oliveira Junior MT, Sabti Z, Noveanu M, Socrates T, Bayes-Genis A, Sionis A, Simon P, Michou E, Gujer S, Gori T, Wenzel P, Pfister O, Arenja N, Kobza R, Rickli H, Breidthardt T, Munzel T, Mueller C; GALACTIC Investigators. Comprehensive vasodilatation in women with acute heart failure: Novel insights from the GALACTIC randomized controlled trial. Eur J Heart Fail. 2023 Dec;25(12):2218-2229. doi: 10.1002/ejhf.3065. Epub 2023 Nov 9.
- Kozhuharov N, Goudev A, Flores D, Maeder MT, Walter J, Shrestha S, Gualandro DM, de Oliveira Junior MT, Sabti Z, Muller B, Noveanu M, Socrates T, Ziller R, Bayes-Genis A, Sionis A, Simon P, Michou E, Gujer S, Gori T, Wenzel P, Pfister O, Conen D, Kapos I, Kobza R, Rickli H, Breidthardt T, Munzel T, Erne P, Mueller C; GALACTIC Investigators; Mueller C, Erne P, Muller B, Rickli H, Maeder M, Tavares de Oliveira M Jr, Munzel T, Bayes-Genis A, Sionis A, Goudev A, Dimov B, Hartwiger S, Arenja N, Glatz B, Herr N, Isenrich R, Mosimann T, Twerenbold R, Boeddinghaus J, Nestelberger T, Puelacher C, Freese M, Vogele J, Meissner K, Martin J, Strebel I, Wussler D, Schumacher C, Osswald S, Vogt F, Hilti J, Barata S, Schneider D, Schwarz J, Fitze B, Hartwiger S, Arenja N, Glatz B, Herr N, Isenrich R, Mosimann T, Twerenbold R, Boeddinghaus J, Nestelberger T, Puelacher C, Freese M, Vogele J, Meissner K, Martin J, Strebel I, Wussler D, Schumacher C, Osswald S, Vogt F, Hilti J, Barata S, Schneider D, Schwarz J, Fitze B, Arenja N, Rentsch K, Bossa A, Jallad S, Soeiro A, Georgiev D, Jansen T, Gebel G, Bossard M, Christ M. Effect of a Strategy of Comprehensive Vasodilation vs Usual Care on Mortality and Heart Failure Rehospitalization Among Patients With Acute Heart Failure: The GALACTIC Randomized Clinical Trial. JAMA. 2019 Dec 17;322(23):2292-2302. doi: 10.1001/jama.2019.18598.
- Nyolczas N, Dekany M, Muk B, Szabo B. Combination of Hydralazine and Isosorbide-Dinitrate in the Treatment of Patients with Heart Failure with Reduced Ejection Fraction. Adv Exp Med Biol. 2018;1067:31-45. doi: 10.1007/5584_2017_112.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Candesartan cilexetil | Unknown | — | — |
| Subject | Nitroglycerin | Unknown | — | Other |
| Subject | Ramipril | Small molecule | — | — |