Effect of Bromocriptine on Left Ventricular Function in Women With Peripartum Cardiomyopathy

Phase 2 Completed 64 enrolled Hannover Medical School German Federal Ministry of Education and Research · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, controlled clinical trial to evaluate the efficacy and safety of bromocriptine for improvement of left ventricular function of women with Peripartum cardiomyopathy (PPCM). A Multi center trial in Germany.

Timeline

Start: 2010-06
Primary completion: 2016-03
Completion: 2016-08

Outcome

Missed primary endpoint

paper delta-LVEF: P = 0.381 PMID 28934837 ↗

paper No significant differences were observed between 1W and 8W treatment PMID 28934837 ↗

Publications

Feyen E, Ricke-Hoch M, Van Fraeyenhove J, Vermeulen Z, Scherr M, Dugaucquier L, Viereck J, Bruyns T, Thum T, Segers VFM, Hilfiker-Kleiner D, De Keulenaer GW. ERBB4 and Multiple MicroRNAs That Target ERBB4 Participate in Pregnancy-Related Cardiomyopathy. Circ Heart Fail. 2021 Jul;14(7):e006898. doi: 10.1161/CIRCHEARTFAILURE.120.006898. Epub 2021 Jul 12.
Hilfiker-Kleiner D, Haghikia A, Berliner D, Vogel-Claussen J, Schwab J, Franke A, Schwarzkopf M, Ehlermann P, Pfister R, Michels G, Westenfeld R, Stangl V, Kindermann I, Kuhl U, Angermann CE, Schlitt A, Fischer D, Podewski E, Bohm M, Sliwa K, Bauersachs J. Bromocriptine for the treatment of peripartum cardiomyopathy: a multicentre randomized study. Eur Heart J. 2017 Sep 14;38(35):2671-2679. doi: 10.1093/eurheartj/ehx355.
Haghikia A, Podewski E, Berliner D, Sonnenschein K, Fischer D, Angermann CE, Bohm M, Rontgen P, Bauersachs J, Hilfiker-Kleiner D. Rationale and design of a randomized, controlled multicentre clinical trial to evaluate the effect of bromocriptine on left ventricular function in women with peripartum cardiomyopathy. Clin Res Cardiol. 2015 Nov;104(11):911-7. doi: 10.1007/s00392-015-0869-5. Epub 2015 May 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bromocriptine	Small molecule	2.5 mg	Oral