Evaluating pregnancy factors and biomarkers in heart failure prognosis
Official title: Association of Heterogeneous Circulating Biomarkers and Anamnestic Factors of Pregnancy Adverse Course and Outcomes With the Prognosis of Heart Failure With Preserved Ejection Fraction
Run by National Medical Research Center for Therapy and Preventive Medicine · NCT06803849 · Data updated 2026-11-12
This study is trying to see how pregnancy-related factors and certain blood markers affect the heart health of women aged 60-74 who have heart failure with preserved ejection fraction.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 60 Years to 74 Years |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | National Medical Research Center for Therapy and Preventive Medicine Government |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Moscow) |
| Status | Recruiting |
| Started | November 15, 2024 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | January 31, 2025 |
| Trial ID | NCT06803849 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 60-74 with a history of pregnancy lasting at least 20 weeks and diagnosed with heart failure with preserved ejection fraction.
✕Probably not a fit
Patients with a history of ejection fraction less than 50%, cognitive impairment, or severe comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the relationship between various circulating biomarkers and pregnancy-related factors with the prognosis of heart failure with preserved ejection fraction (HFPEF) in women aged 60-74. Participants must have a history of pregnancy lasting at least 20 weeks and a diagnosis of HFPEF based on the HFA-PEFF algorithm. Data will be collected through questionnaires and medical records, focusing on pregnancy complications such as gestational hypertension, preeclampsia, and gestational diabetes. A short physical examination will also be conducted during the initial visit.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how pregnancy-related factors influence heart failure prognosis, potentially leading to better management strategies for affected patients.
How similar studies have gone: While this study explores a novel association, similar studies have shown that understanding pregnancy complications can provide insights into cardiovascular risks.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women aged 60-74 years * Heart failure with preserved ejection fraction (diagnosed by using HFA-PEFF algorithm) * History of pregnancy with duration at least 20 weeks * Willing and legally able to sign informed consent Exclusion Criteria: * History of ejection fraction less than 50% diagnosed by echocardiography * Diagnosed cognitive impairment or dementia * The state of cardiovascular disease decompensation * Exacerbation of comorbidities * The presence of chronic diseases that may affect the results of the study: ischemic heart disease (unstable angina, stable effort angina III-IV grade, previous myocardial infarction), previous Ischemic/hemorrhagic stroke, severe valvular heart diseases, cardiomyopathy, myocarditis, uncontrolled bronchial asthma or chronic obstructive pulmonary disease, terminal chronic kidney disease requiring dialysis, implanted pacemaker (including cardiac resynchronisation device, or defibrillator), active cancer, history of chemotherapy or radiation therapy to the chest area
Where it's running
-
Federal State Budgetary Institution National Medical Research Center for Therapy and Preventive Medicine of the Ministry of Healthсare of the Russian Federation
Moscow, Russia Recruiting
Study contacts
- Study coordinator: Vasilisa Kosulina, MD
- Email: vasilisa.kosulina@mail.ru
- Phone: +7-996-981-40-27
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.