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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age60-74
SponsorNational Medical Research Center for Therapy and Preventive Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

History of ejection fraction less than 50% diagnosed by echocardiography

Diagnosed cognitive impairment or dementia

The state of cardiovascular disease decompensation

Exacerbation of comorbidities

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: Patients with anamnestic factors of pregnancy adverse course and outcomes
Group B: Patients without anamnestic factors of pregnancy adverse course and outcomes

Trial outcomes

Primary outcomes

1

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

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

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

Secondary outcomes

1

Newly diagnosed chronic non-communicable disease

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

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

Other outcomes

Sponsors and contacts

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