Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06393595 |
| Other study ID # |
CHF-RS001 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2022 |
| Est. completion date |
June 20, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Samara State Medical University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Chronic heart failure (CHF) is a syndrome complicating heart disease, the prevalence of which
has reached epidemic levels. According to global statistics the most common causes of CHF are
coronary heart disease (CHD): 26.5%, arterial hypertension (AH):26.2% . The category of
patients with CHD complicated by CHF prevails in clinical practice, requiring an optimized
approach to determining prognosis in order to improve the effectiveness of therapy. In the
literature, this issue has been studied with the use of general clinical, biochemical,
instrumental criteria. Nevertheless, the problem of optimized prognosis in patients with CHF
remains. Its solution may lie in the study of metabolic parameters of biological media -
skin, blood serum by Raman spectroscopy.
Skin is an accessible tissue for studying the effects of a wide range of age-dependent
noncommunicable diseases, including cardiovascular disease, type 2 diabetes mellitus, and
chronic kidney disease. We were one of the first to use skin RS as a method of determining
renal dysfunction, a necessary component of chronic kidney disease. However, the
applicability of RS/SERS in the diagnosis and prognosis of specific diseases, as well as in
the collection of statistical data for this analytical approach, remains an open question .
Despite the fact that the method is classified as analytical, it can be used to identify not
so much specific chemical molecules as their specific loci, which provide vibrations that
change the wavelengths of the scattered spectrum. The resulting spectrum can be presented as
a metabolic "portrait" of the disease, with the most informative loci, the combination of
which is associated with a negative prognosis.
The innovative analytical methods of optical spectroscopy proposed in this project provide
new level information about hundreds of molecules and their active centers that have
prospects as biomarkers. This study aims to determine the clinical relevance of skin and
serum RS in patients with CHF, realized on state-of-the-art instrumentation in a
comprehensive patient study setting. The research proposed in this project will contribute to
the development of high-tech production of new optical devices for rapid diagnosis and
prognosis of a wide range of diseases.
Description:
This study included participants hospitalized in the cardiology unit of Samara city Clinical
Hospital No.1 n.a. N.I.Pirogov of Emergency Medical Aid.The reason for hospitalization was
newly diagnosed chronic heart failure or its exacerbation.
Objective: 1) to develop a personalized approach to prediction of total mortality,
cardiovascular death in patients with CHD complicated by CHF on the basis of Raman spectra of
skin, plasma, blood serum.
2)To develop a classification of Raman spectra characteristic for CHF, as well as its
phenotypes and relevant comorbid conditions - Chronic kidney disease (CKD) and glycemic
status.
Study Material:
1. Group with CHF based on CHD of both sexes aged 35 to 84 years (200 participants);
2. Group with CHD without CHF (70 participants);
3. Group with CHF with non-ischemic cardiomyopathies (50 participants);
4. group with CHF and valvular cardiomyopathies (40 participants)
The study design is divided into two consecutive parts:
A)cross-sectional cohort . B)prospective
Cross-sectional study (part 1). Material: groups 1-4.
Objectives:
1. To identify Raman spectral characteristics specific to the CHF syndrome, skin RS and
serum SERS would be performed in groups of different CHF etiology: noncomplicated CHD ;
CHD complicated by CHF; non-ischemic Cardiomyopathies (CMP) complicated by CHF(Dilated
CMP, Inflammatory CMP,; valvular CMPs ).
2. To study the influence of CHF phenotypes (divided by Left Ventricular ejection fraction
(LVEF)), as well as comorbidity - chronic kidney disease, type 2 diabetes mellitus(DM2)
on skin and serum Raman spectra, biochemical parameters in the group with CHD.
Prospective study (part 2) Study material: group 1.
Objectives:
3. To establish the possibilities of serum SERS and skin RS parameters in predicting
overall mortality in patients with CHD complicated by CHF in comparison with prediction
models based on parameters of clinical, biochemical and instrumental routine techniques.
4. Develop prediction models for total mortality, CV mortality, and CV mortality in
combination with hospitalizations for CHD participants with CHF .
5. To establish relationships with the most prognostically important spectral components of
RS and known markers of atherosclerosis and cardiovascular diseases (CVD): CKD
parameters; troponin T, glucose; cholesterol spectrum parameters.
Planned period of the cross-sectional phase of the study: November 2022 to May 2023.
Visit 1- Determination of inclusion/exclusion criteria for recruitment. Collection of
clinical, biochemical, instrumental parameters. Determination of serum SERS and skin RS.
Planned period of the prospective study: November 2022-May 2024. Visit -1 is used to include
only participants from group (1) in the prospective part of the study: CHD+CHF.
Visit-2 is planned at 4-6 months after the initial evaluation. The aim of visit-to assess
patient's clinical status and compliance to prescribed medication.
Visit 3 (end of prospective follow-up ).The purpose of the visit - to collect information
about hospitalizations and complications that occurred after visit 2. In case of death
according to relatives' information, to confirm the fact of death in the electronic medical
information analytical system (EMIAS).
Scientific novelty of the research: The technology of surface enhanced Raman spectroscopy
(SERS) of blood serum on nanosilver substrate will be tested. Artificial intelligence
technology is used for discriminative analysis based on SERS parameters.
Spectral features due to the influence of CVD, diabetes mellitus and renal dysfunction will
be specified on RS of skin and serum SERS highlighted for the first time .
For the first time, the RS of skin, serum of non-ischemic CMPs and valvular CMPs is studied.
For the first time, a prognostic model using skin RS, SERS of patients with CHD complicated
by CHF is proposed.
Based on the results of the study, models will be developed to predict mortality and
cardiovascular complications in patients with CHD complicated by CHF.
Expected Results:
Mathematical models will be developed to predict cumulative mortality, CV mortality and
cumulative target, including CV mortality and hospitalizations for exacerbations of CHF,
based on independent predictors of biochemical, clinical, skin and serum Raman spectrometry
parameters.
Spectral regions reflecting the influence of chronic heart failure syndrome as such will be
identified (by comparing serum SERS of patients with different etiologies of CHF).
Spectral characteristics of three phenotypes of CHF will be identified: with preserved LVEF;
moderately reduced LVEF; low LVEF.
Spectral characteristics specific for chronic kidney disease and DM2 will be identified.
