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A long-term observational study of 52,330 women in Israel found no higher rates of heart attack, stroke, blood clots or death before age 80 among women who started contemporary hormone replacement therapy (HRT) than among women who did not. The findings are preliminary and do not prove that HRT causes no cardiovascular harm; researchers will present them at the American Heart Association Scientific Sessions on Nov. 6-9, 2026.
A study tracking 52,330 women in Israel found similar rates of heart attack, stroke, blood clots and death before age 80 among women who started contemporary hormone replacement therapy (HRT) and women who did not. The preliminary findings, based on an average of 12 years of follow-up, address concerns about cardiovascular risks for women using HRT to manage menopause symptoms, but the observational design cannot establish cause and effect.
The research included women ages 45 to 59 with no recorded history of heart disease, blood clots or cancer. About half had started HRT, primarily through oral medication or skin patches; the comparison group had recently visited a gynecologist but did not start HRT and did not use it during the study period. Researchers used Clalit Health Services records and matched the groups on factors including age, body mass index, blood pressure, cholesterol, diabetes, smoking and socioeconomic status.
During follow-up, 2,311 women in the HRT group (4.4%) had a heart attack, stroke or related heart disease, compared with 2,383 women (4.6%) in the non-HRT group. Blood clots were recorded in 174 HRT users and 175 nonusers, or 0.33% in each group. Death before age 80 occurred in 659 women taking HRT (1.3%) and 653 women not taking it (1.2%). The researchers said results were similar across the HRT formulations and routes examined, including oral, patch and gel.
The study examined health records for up to 23 years, with an average follow-up of 12 years. Researchers assessed cardiovascular outcomes and death from any cause before age 80. The work is described as independent and preliminary, and is due to be presented at the American Heart Association’s Scientific Sessions 2026 in Chicago, Nov. 6-9. The available report does not provide a peer-reviewed journal publication or detailed statistical estimates such as confidence intervals.
What the Findings Mean for HRT Decisions
Menopause symptoms can affect quality of life, while concern about heart and blood-clot risks can influence whether patients and clinicians consider hormone therapy. The study offers long-term observational evidence about contemporary HRT in women who began treatment between ages 45 and 59 and had no prior cardiovascular disease. Its results may inform discussions about treatment, but they do not show that HRT is appropriate for every woman or remove the need to weigh individual health factors.
Cardiovascular events were close in frequency between the matched groups, and clot rates were reported as the same. That is reassuring in the population studied, but the results should not be generalized automatically to women outside the study’s age range, those with prior heart disease or clots, or people using different treatments. As an observational comparison, the study can identify an association, not prove that HRT itself did or did not cause the outcomes.
Stacey E. Rosen, a women’s heart health specialist who was not involved in the research, said the findings can support more informed conversations between women and their healthcare teams. Those conversations still need to account for the patient’s symptoms, medical history and treatment options rather than relying on a population-level result alone.
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How This Study Fits Earlier HRT Evidence
Earlier randomized trials linked HRT with cardiovascular harm, but the report says those findings were mixed and much of the evidence involved older formulations, higher doses or women who began therapy well after menopause. The current study focuses on women in a younger age range and treatments described as contemporary. That difference in populations and formulations is one reason the new findings add information without settling the wider safety question.
Current American College of Obstetricians and Gynecologists guidance recommends starting HRT within 10 years of menopause onset and before age 60. In November 2025, the U.S. Food and Drug Administration removed black-box warnings from HRT products after reviewing current scientific data. The study report says that review found HRT was not associated with increased cardiovascular disease, breast cancer or dementia risk. The FDA action and the new research are separate developments; the study does not itself establish the basis for the agency’s decision.
Researchers drew on records from Clalit Health Services, matching HRT users with women who had seen a gynecologist but did not begin treatment. Matching addressed several recorded risk factors, but it cannot account for every difference between groups. The comparison therefore offers evidence about outcomes in this health-record population, not a randomized test of therapy.
“Our results indicate that, 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.”
— Ronen Arbel, Ph.D., lead study researcher
Limits of the Observational Evidence
The study was observational, so it cannot show that HRT caused the outcomes or that it would have the same effects under randomized conditions. The researchers also said health records may not capture other differences between women who chose HRT and those who did not; the report gives exercise as an example. Such unmeasured factors could affect comparisons between the groups.
The findings concern women ages 45 to 59 without a recorded history of heart disease, blood clots or cancer. They do not directly answer questions about HRT use among older women, people with those medical histories, or other patient groups. The report also does not give detailed results for individual formulations or doses beyond saying the overall pattern was similar across the routes and formulations assessed.
The findings are preliminary and are scheduled for conference presentation. The source material does not state whether a full paper has been submitted to a journal, nor does it provide confidence intervals or other details needed to assess the precision of the estimates. Those details may help readers and clinicians judge how confidently small differences between groups can be interpreted.
Conference Presentation and Further Review
Researchers are scheduled to present the findings at the American Heart Association Scientific Sessions in Chicago from Nov. 6 to 9, 2026. The conference presentation may provide further information about methods, outcome definitions and statistical analysis. The supplied report does not specify whether the researchers plan additional analyses or a journal publication.
For now, the results add to evidence about contemporary HRT but do not replace individualized clinical advice. Women considering treatment can discuss potential benefits and risks with a qualified healthcare professional who knows their medical history. Any later publication or additional study results could clarify how broadly these findings apply.
Key Questions
What did the study find about HRT and cardiovascular risk?
In this study, HRT use was not associated with higher observed rates of heart attack, stroke, blood clots or death before age 80 compared with no HRT. The observational design cannot prove that HRT has no effect on cardiovascular risk.
Who was included in the research?
The study covered 52,330 women ages 45 to 59 in Israel who had no recorded history of heart disease, blood clots or cancer. About half had started HRT, and researchers matched the groups using several recorded health and social factors.
How long were participants followed?
Records covered up to 23 years, and the average follow-up was 12 years. The researchers compared cardiovascular outcomes and death before age 80.
Does the study prove HRT is safe for everyone?
No. It was an observational study of a specific group, so it cannot establish cause and effect or answer questions for every age group and health history. Treatment decisions should be discussed with a qualified healthcare professional.
Source: news-medical.net
