A large, long-term study of more than 52,000 women in Israel has found that initiating contemporary hormone replacement therapy (HRT) among women ages 45 to 59 did not increase the risk of heart attack, stroke, blood clots or death. The preliminary findings, presented at the American Heart Association’s Scientific Sessions 2026, offer reassurance to women and clinicians who have long worried about the cardiovascular safety of hormone therapy for menopause symptoms.
“Concerns that hormone replacement therapy may affect the heart is one of the most common reasons women decline hormone therapy to manage menopause symptoms, and why some healthcare professionals may hesitate to offer it,” said lead study researcher Ronen Arbel, Ph.D., a researcher in the community medical services division of Clalit Health Services in Tel Aviv, Israel, and a researcher with Sapir College’s Maximizing Health Outcomes Research Lab in Sderot, Israel.
The study evaluated data for 52,330 women aged 45–59 with no history of heart disease, blood clots or cancer. Half had started HRT, primarily via oral and/or transdermal (patch) methods, while the other half had recently visited a gynecologist but did not begin HRT. Researchers matched the groups by age, BMI, cardiometabolic risk factors, smoking status and socioeconomic status. After an average follow-up of 12 years, health outcomes were similar between the two groups. Specifically, 4.4% of women in the HRT group experienced a heart attack, stroke or related heart disease versus 4.6% in the no-HRT group. Death before age 80 occurred in 1.3% of the HRT group versus 1.2% of the no-HRT group, and blood clots occurred in 0.33% of both groups. Results were consistent across all HRT formulations and administration routes (oral, patch or gel).
The findings matter because previous randomized trials, such as the Women’s Health Initiative, linked older HRT formulations to cardiovascular harm. However, those studies used higher doses and often involved women who started HRT long after menopause. Current guidelines from the American College of Obstetricians and Gynecologists recommend starting HRT within 10 years of menopause onset and before age 60. In November 2025, the FDA removed the “black box” warnings from HRT products after a comprehensive review of current scientific data indicating that HRT is not associated with increased risk of cardiovascular disease, breast cancer or dementia. This new study adds to that evolving evidence base.
“For many women, menopause symptoms can significantly affect their quality of life, yet questions about the cardiovascular safety of hormone therapy have remained,” said Stacey E. Rosen, M.D., FAHA, an expert in women’s heart health and past volunteer president of the American Heart Association (2025-2026). “This large, long-term study adds to growing evidence that today’s hormone therapy options may not increase the risk of heart disease, stroke or blood clots for healthy women who begin treatment around the time of menopause.” Rosen, who was not involved in the study, is also executive director of the Katz Institute for Women’s Health and senior vice president of women’s health at Northwell Health in New York City.
The research has limitations. It is an observational study, so it cannot prove a direct connection between HRT and heart health. The researchers also noted that there may be other differences among the women taking HRT versus those who do not that were not available in the health records, such as differences in exercise, diet, other health conditions and severity of menopause symptoms. Additionally, the study grouped women by the first type of hormone therapy they used and did not include any changes in HRT type or formulation throughout the follow-up period.
For women in their mid-forties to late fifties with no history of heart disease or blood clots, the currently available hormone therapies prescribed to manage menopause symptoms do not appear to raise the risk of heart attack, stroke, clots or early death, even after long-term use, Arbel said. The findings are considered preliminary until published as a full manuscript in a peer-reviewed scientific journal. The abstract and the American Heart Association’s Scientific Sessions 2026 Online Program Planner are available. Additional resources include a release link with multimedia and a Spanish news release. For more information on cardiovascular risk during menopause, see the American Heart Association’s : Menopause and Cardiovascular Risk.
