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NCT Number: NCT06803849

Association of Heterogeneous Circulating Biomarkers and Anamnestic Factors of Pregnancy Adverse Course and Outcomes With the Prognosis of Heart Failure With Preserved Ejection Fraction

The primary purpose of this study is to evaluate possible association of some heterogeneous circulating biomarkers and anamnestic factors of pregnancy adverse course and outcomes with the prognosis of heart failure with preserved ejection fraction. The study population includes women aged 60-74 years with history of pregnancy with duration at least 20 weeks and diagnosed heart failure with preserved ejection fraction based on algorithm HFA-PEFF.

The following pregnancy complications are assessed on the initial visit: gestational hypertension, preeclampsia, gestation diabetes mellitus and recently introduced as cardiovascular disease risk factors preterm delivery, stillbirth, miscarriage. This information is collected through a questionnaire which additionally includes questions about menopause and the circumstances of its onset. The data about comorbidities, results of laboratory and instrumental tests is collected from medical records. After the interview short physical examination is performed to measure anthropometric data and objective signs of congestion. In addition, medical Research Council Scale survey is conducted to assess the subjective severity of shortness of breath and a six-minute walking test to objectively evaluate the heart failure functional class.

After inclusion in the study blood sampling is performed to measure the concentration of a number of biomarkers which are recognized as prognostically significant in context of heart failure: high-sensitivity troponin I, soluble suppression of tumorigenicity 2 protein, heat shock protein 27, cystatin C. As part of the study echocardiography is also performed with evaluation of left ventricular global longitudinal strain and left atrial strain to assess systolic and diastolic myocardium function.

12 months after the initial visit, participants are contacted by telephone. The data about newly diagnosed chronic non-communicable diseases, emergency hospitalization for any cause and major adverse cardiovascular events is collected. If there is no response from the research participant, the cause, including possible hospitalization or death, is determined by telephone contact with the participant's trusted person.

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Key information

Age range

60 year–74 year

Sex eligibility

Female

Study type

Observational

Primary location

Federal State Budgetary Institution National Medical Research Center for Therapy and Preventive Medicine of the Ministry of Healthсare of the Russian Federation

Moscow, 101990, Russia

Location status: Recruiting

Location contact

Olga Dzhioeva, MD, PhD

CONTACT

[email protected]

+7-916-614-18-21

Vasilisa Kosulina, MD

CONTACT

[email protected]

+7-996-981-49-27

Vasilisa Kosulina, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Combined endpoint made up of emergency hospitalization for any cause, major adverse cardiovascular events and all-cause mortality

    Time frame: From the date of enrollment until the date of the first emergency hospitalization for any cause or date of any major adverse cardiovascular event or all-cause death, whichever came first, assessed up to 1 years

    Major adverse cardiovascular events include myocardial infarction, stroke, cardiovascular death

Secondary outcomes

  1. Newly diagnosed chronic non-communicable disease

    Time frame: From the date of enrollment until the date of diagnosis of any chronic non-communicable disease, whichever came first, assessed up to 1 years

    Chronic non-communicable diseases include cardiovascular diseases, respiratory system diseases, diabetes mellitus, cancer

Study contacts

Contact information is provided by the study sponsor or research team.

Olga Dzhioeva, MD, PhD

CONTACT

[email protected]

+7-916-614-18-21

Vasilisa Kosulina, MD

CONTACT

[email protected]

+7-996-981-40-27

Sponsors and collaborators

Lead sponsor

National Medical Research Center for Therapy and Preventive Medicine

Other Gov

Registry information

Acronym: CARPO-HF

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 31, 2025
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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