US researchers awarded NIH funding for global maternal heart failure trial

A global trial will test whether bromocriptine can reduce deaths and complications in women with pregnancy-related heart failure.

The study focuses on peripartum cardiomyopathy (PPCM), a rare but life-threatening form of heart failure that develops towards the end of pregnancy or within five months of childbirth.

The placebo-controlled trial will enrol approximately 650 women to assess whether adding bromocriptine to standard heart failure treatment improves outcomes for mothers and infants.

The University of Alabama at Birmingham (UAB) will coordinate the GLOBal PPCM trial, which has received funding over seven years from the US National Heart, Lung, and Blood Institute.

The trial has been approved to launch in 15 countries, including 13 low- and middle-income countries, across more than 15 research sites.

Professor Alan Tita and Dr Rachel Sinkey are leading the research at UAB.

Sinkey said: “Bromocriptine has shown encouraging signals in smaller studies; but the field has lacked the large-scale evidence needed to determine whether it improves the outcomes that matter most, including survival and serious maternal morbidity.

“GLOBal PPCM was specifically designed to address that gap while also rigorously evaluating maternal and infant safety.”

Researchers will assess whether bromocriptine reduces maternal deaths, persistent heart failure and other complications associated with the condition.

PPCM is a leading contributor to maternal deaths in the later postpartum period in the US and globally. In some low- and middle-income countries, it leads to severe heart failure or death in at least 20 per cent of cases.

Its precise cause remains unclear, but emerging evidence suggests prolactin, a hormone involved in breast milk production, may contribute to the disease’s progression.

Bromocriptine activates dopamine receptors and suppresses prolactin production.

Smaller preclinical and clinical studies have suggested the medication could improve heart muscle recovery and reduce maternal deaths and complications.

However, its effectiveness and safety for mothers and infants have yet to be established in a sufficiently large global study.

The trial will also monitor the potential effects of bromocriptine-induced suppression of breast milk production, particularly in populations where breastfeeding is common.

Participating countries include Bangladesh, Cameroon, the Democratic Republic of the Congo, Dominican Republic, Ethiopia, Ghana, Jamaica, Kenya, Mozambique, Rwanda, Uganda and Zambia.

Research teams across Africa, Asia, the Caribbean, Europe and North America will take part, with further countries and sites potentially joining as the study progresses.

RTI International, the University of Pittsburgh and McMaster University will contribute expertise in trial implementation, regulatory oversight and cardiovascular clinical trials methodology.

UAB’s Mary Heersink Institute for Global Health and Center for Research in Women’s Health will coordinate the trial, while the university’s DATA Coordinating and Collaborative Research Unit will oversee data coordination.

Tita said: “Peripartum cardiomyopathy remains one of the most devastating complications of pregnancy, particularly in the US and other settings where maternal mortality remains high.

“This trial represents years of planning and collaborative partnership across continents to answer a question that has enormous implications for mothers and families around the world.”

Researchers hope to establish whether adding bromocriptine to standard treatment improves survival and reduces serious complications.

If the medication proves safe and effective, the findings could inform future clinical practice for women with peripartum cardiomyopathy.