AAV1-CMV-Serca2a GENe Therapy Trial in Heart Failure

NCT01966887 ↗

Phase 2 Terminated 10 enrolled Assistance Publique - Hôpitaux de Paris Celladon Corporation · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine the effect of intracoronary SERCA2a Gene transfer on cardiac volumes and function using multimodality cardiac imaging.

Timeline

Start: 2013-12
Primary completion: 2015-09
Completion: 2016-02

Outcome

Missed primary endpoint

paper P = 0.74, with a mean difference between groups of 11.4 mL in favour of placebo. PMID 28393439 ↗

paper AGENT-HF failed to demonstrate any improvement in ventricular remodelling in response to AAV1/SERCA2a at the dose studied. PMID 28393439 ↗

Publications

Results Hulot JS, Salem JE, Redheuil A, Collet JP, Varnous S, Jourdain P, Logeart D, Gandjbakhch E, Bernard C, Hatem SN, Isnard R, Cluzel P, Le Feuvre C, Leprince P, Hammoudi N, Lemoine FM, Klatzmann D, Vicaut E, Komajda M, Montalescot G, Lompre AM, Hajjar RJ; AGENT-HF Investigators. Effect of intracoronary administration of AAV1/SERCA2a on ventricular remodelling in patients with advanced systolic heart failure: results from the AGENT-HF randomized phase 2 trial. Eur J Heart Fail. 2017 Nov;19(11):1534-1541. doi: 10.1002/ejhf.826. Epub 2017 Apr 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MYDICAR	Gene therapy (AAV / viral vector)	1e+13 unknown	Other