Pulmonary Hypertension and Anastrozole Trial

Phase 2 Completed 84 enrolled University of Pennsylvania Johns Hopkins University · collab National Heart, Lung, and Blood Institute (NHLBI) · collab Rhode Island Hospital · collab Stanford University · collab University of Colorado, Denver · collab Vanderbilt University · collab Washington University School of Medicine · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objectives of this study are to determine whether the study drug, anastrozole may improve six minute walk distance at six months compared to placebo and to assess safety and side effects up to twelve months in pulmonary arterial hypertension (PAH).

Timeline

Start: 2017-12-07
Primary completion: 2022-07-22
Completion: 2022-07-22

Outcome

Missed primary endpoint

paper There was no significant difference in the change in 6MWD at 6 months PMID 38747680 ↗

paper placebo-corrected treatment effect, -7.9 m; 95% confidence interval, -32.7 to 16.9; P = 0.53 PMID 38747680 ↗

Publications

Kawut SM, Feng R, Ellenberg SS, Zamanian R, Bull T, Chakinala M, Mathai SC, Hemnes A, Lin G, Doyle M, Andrew R, MacLean M, Stasinopoulos I, Austin E, DeMichele A, Shou H, Minhas J, Song N, Moutchia J, Ventetuolo CE. Pulmonary Hypertension and Anastrozole (PHANTOM): A Randomized, Double-Blind, Placebo-Controlled Trial. Am J Respir Crit Care Med. 2024 Nov 1;210(9):1143-1151. doi: 10.1164/rccm.202402-0371OC.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Anastrozole	Other / unclassified	1 mg	Oral