Pilot study for peripartum cardiomyopathy
Peripartum cardiomyopathy (PPCM) is characterized by acute heart failure late in pregnancy or early in the postpartum period. The incidence of PPCM ranges from 1 in 1000 to 2000 pregnant women in the United States to 1 in 1000 in South Africa and 1 in 300 in Haiti. Current therapy has limited effectiveness, and as many as one third to two thirds of patients may fail to recover cardiac function.
Dr. Denise Hilfiker-Kleiner, of the Adaptive and maladaptive signaling in cardiac growth and regeneration network, had previously discovered an abnormal form of the hormone prolactin in women with PPCM. Moreover, she found that bromocriptine, a blocker of prolactin release, might prevent the recurrence of PPCM with subsequent pregnancies.
Most recently, Dr. Hilfiker-Kleiner and collaborators from Beligum, South Aftrica, the United Kingdom, and the United States conducted a proof-of-concept, open-label pilot study to see whether bromocriptine could be an effective treatment for PPCM.
The study was conducted at Chris Hani Baragwanath Hospital, a public hospital in Soweto, South Africa. Twenty women were randomized into two groups, those who received standard heart failure medications, and those who, in addition to standard medications, received bromocriptine during a total of 8 weeks. The outcomes were evaluated at 6 months.
Women in the bromocriptine group had greater improvements in heart failure symptoms and cardiac function. For instance, while at the start of the study the left ventricular ejection fraction, a measure of the pumping capacity of the heart, was similar between the two groups (27% in both the standard treatment and bromocriptine groups), a much more dramatic improvement was observed in the bromocriptine group at 6 months (58%, compared to 36% in the standard treatment group). Four patients in the standard treatment group died, compared to 1 in the bromocriptine group. Bromocriptine appeared to be well tolerated, without any associated complications. Infants of mothers in both groups showed normal growth and survival.
While the study was non-blinded and included only a small number of patients in each treatment arm, it provides initial proof of concept for a role of bromocriptine in PPCM treatment. Larger, blinded studies involving multiple centers are necessary to evaluate the safety and efficacy of bromocriptine.
This study was also funded by the Medical Research Council of South Africa and the University of the Witwatersrand.
Click on the title to access the article in the April 6, 2010 issue of Circulation: Evaluation of bromocriptine in the treatment of acute severe peripartum cardiomyopathy: a proof-of-concept pilot study.