Innovative drug trial looks to restore heart health in postpartum mothers

LEXINGTON, Ky. (Sept. 20, 2024) – After the birth of her little girl, Bella, Marishia Hamilton of Lexington knew something wasn’t right. 

Marishia was exhausted and constantly out of breath. She didn’t recall feeling that way after the birth of her son Bryson, 12 years prior.  

“I just chalked it up to being a new mom,” Marishia said. “I hadn’t had a baby in 12 years. I just thought I needed to adjust.” 

She followed up with a doctor, who advised her to get more rest. A second doctor said she needed to be more active. 

“I felt defeated,” she said. “I don’t know what to do. Do I get more rest, or do I be more active? How am I supposed to get rest with a newborn?” 

A month after giving birth, Marishia had a terrible coughing spell. She couldn’t stop coughing, couldn’t catch her breath. She handed baby Bella to Bryson, terrified that she was going to drop her. 

At the emergency department at the University of Kentucky Good Samaritan Hospital, doctors there could tell something was very wrong. She was transferred to UK Albert B. Chandler Hospital, where, just a few days into her week-long stay, she was given a potentially devastating diagnosis: peripartum cardiomyopathy (PPCM). 

“I had never even heard of it,” Marishia said. “Even after I Googled, I still didn’t understand. I had no idea I was in heart failure.” 

Peripartum cardiomyopathy is a rare form of heart failure that occurs at either the end of pregnancy or the first few months following delivery. The exact cause of PPCM is unknown.  There may be a genetic component, although most women who develop PPCM have no family history of heart failure. 

“Most often a women will present in the latter stages of their pregnancy, or in the first few months after they give birth,” said Navin Rajagopalan, M.D., heart failure specialist in UK HealthCare’s Gill Heart & Vascular Institute. “These are women that had no previous cardiac history, never had a heart attack in the past and they never had heart failure. Women present with shortness of breath, swelling, fatigue, but all of these symptoms can be felt after childbirth as well. As a result, peripartum cardiomyopathy can be difficult to diagnose.” 

After the diagnosis, Marishia realized her symptoms made sense. She was winded even walking downhill. Her care team was surprised that she was as active as she was given her condition. But the relief she felt at finally having answers was short-lived. As a mother of four, her thoughts immediately turned to her children. 

“I called my dad, my boyfriend and my aunt and told them I had a heart problem,” Marishia said. “I was in a complete panic because I can’t leave my babies.” 

Marishia was referred to Rajagopalan, who ensured her that she was on medications that are known to benefit patients with heart failure.  He also approached Marishia about participating in a drug trial that is investigating whether an additional medication would be beneficial for patients with peripartum cardiomyopathy.  

The Randomized Evaluation of Bromocriptine In Myocardial Recovery Therapy study, or REBIRTH, is a study led by researchers and physicians at the University of Pittsburgh. Research suggests that a hormone known as prolactin may play a role in the development of PPCM. Prolactin levels are elevated around the time of childbirth and stimulate the production of milk (lactation) required for breastfeeding. The stress of childbirth sometimes results in the breakdown of prolactin, creating small proteins in the blood which have a negative impact on both blood vessels and the heart. Laboratory models have shown that preventing the release of this hormone with bromocriptine may prevent the development of peripartum cardiomyopathy.  

Marishia was skeptical. She would either receive the drug or a placebo, so she didn’t see the point. The drug could make her better, but what if it didn’t do anything, or even make her condition worse? 

Rajagopalan listened to Marishia’s concerns and assured her that the medication would not hurt her.  As one of UK HealthCare’s leading experts on heart failure, Rajagopalan carefully monitored Marishia throughout the trial period. After eight weeks on the medication, she followed up with Rajagopalan regularly over the course of a year. Both Marishia and Rajagopalan were thrilled to see that she has improved her cardiac function, and she no longer had symptoms of heart failure.   

“It has been quite gratifying to see Marishia improve and be able to lead a normal life,” he said. “Since REBIRTH is a blinded study, neither me nor Marishia know whether she received the active drug bromocriptine or a placebo.  But thanks to courageous patients such as Marishia, we will hopefully be able to improve our care of women in the future.”  

Hearth health is determined by ejection fraction – the amount of blood that is pumped out of the heart with each heartbeat. A normal ejection fraction is 50% or higher; Marisha reports that her heart function is up to 47% and increasing. She now has the energy keep up with Bella, who just started walking.  

“I can actually walk distances and not be so winded,” Marishia said. “That’s wonderful because I feel great, and I feel like I was getting back to myself. I just feel like this will help my babies and my family to have me with them for a longer time.” 

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There is currently uncertainly in the medical community if all women with peripartum cardiomyopathy should be started on bromocriptine. Bromocriptine prevents women from being able to breast feed so starting the medication requires shared decision making between the patient and their doctor. The REBIRTH trial is hoping to provide the definitive answer as to whether bromocriptine has additional benefits to women in addition to standard medical therapy.  The University of Kentucky is one of 50 centers across the country participating in REBIRTH and the only center in Kentucky. Learn more about the study here.