Chronic Heart FailurePROMETHEUSNCT06393595
Prediction of Outcomes in Patients With Chronic Heart Failure Based on Tissue Raman Spectroscopy
An observational study of Chronic Heart Failure, run by Samara State Medical University at 1 site in Russia.
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% . Read more about this study
- Who is it for?
- Ages 35 to 84 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- surface enhanced Raman Spectroscopy
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 1 Nov 2022to 20 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The researchers included participants from among those hospitalized in the cardiology department of an urban acute care hospital (groups 1,3,4)because of first-diagnosed chronic heart failure or its exacerbation. Group 2 consisted of patients with clinically and instrumentally proven chronic ischemic heart disease without manifestations of CHF also hospitalized. Reasons for hospitalization in this group were related to BP elevation, paroxysms of atrial fibrillation/atrial flutter. Selection into the study was made among consecutively admitted patients, provided that the inclusion criteria were met
Who may be able to join
- Group 1(CHD+CHF): clinically evident CHF II-IV NYHA Classes,confirmed by NT-proBNP diagnostic levels. Any form of Coronary Heart Disease :angina pectoris up to and including 2 functional class, previous myocardial infarction, percutaneous coronary intervention or coronary arteries bypass grafts. possible functional insufficiency of A-V valves, arterial hypertension, possibly with chronic atrial fibrillation/atrial fibrillation of any form, ventricular extrasystoles of any class, Hiss bundle branch block not requiring implantation of devices, ability to self-care.
- Group 2(CHD): Any form of Cronic Heart Disease :angina pectoris up to and including 2 functional class, previous myocardial infarction, percutaneous coronary intervention or coronary arteries bypass grafts, possible functional insufficiency of A-V valves of 1 stage, arterial hypertension, possibly with chronic atrial fibrillation/ flatter of any form, ventricular extrasystoles of any class, Hiss bundle branch block not requiring implantation of devices, ability to self-care.
- Group 3 (NICMPs+CHF): clinically evident CHF II-IV NYHA Classes,confirmed by NT-proBNP diagnostic levels without signs of CHD in the history, without violation of coronary anatomy - stenoses (MSCT and coronary angiography). Possible functional insufficiency of A-B valves of the 1st degree, arterial hypertension, possible chronic forms of atrial fibrillation/ flatter, ventricular extrasystoles of any class, blockade of the Hiss legs not requiring implantation of devices, capable of self-care.
- Group 4 (VCMPs+CHF):Valvular acquared cardiomyopathies with clinically evident CHF II-IV NYHA Classes,confirmed by NT-proBNP diagnostic levels without signs of CHD in the history, without violation of coronary anatomy - stenoses (MSCT and coronary angiography). Possible functional insufficiency of A-B valves of the 1st degree, arterial hypertension, possible chronic forms of atrial fibrillation/ flatter, ventricular extrasystoles of any class, blockade of the Hiss legs not requiring implantation of devices, capable of self-care.
- Exclusion Criteria:Exclusion criteria (for groups 1-4): Acute myocardial infarction or unstable angina within the last 6 months, Dementia, lack of signed consent, CKD 4st or higher, tuberculosis, active cancer, liver cirrhosis of infectious etiology, chronic anemia : Hemoglobin less than 95 g/L, inability to self-care, type 1 diabetes mellitus,or insulin-dependent type 2 DM , anticipated heart valve surgery within one year, uncontrolled endocrine disease or malignancy likely to affect prognosis.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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:
- Group with CHF based on CHD of both sexes aged 35 to 84 years (200 participants);
- Group with CHD without CHF (70 participants);
- Group with CHF with non-ischemic cardiomyopathies (50 participants);
- 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:
- 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 ).
- 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:
- 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.
- Develop prediction models for total mortality, CV mortality, and CV mortality in combination with hospitalizations for CHD participants with CHF .
- 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.
- Conditions
- Chronic Heart Failure
- Being tested
- surface enhanced Raman Spectroscopy
- Keywords
- cumulative death, cardiovascular death (CVD), CVD or hospitalization for heart failure exacerbation, surface enhanced Raman Spectroscopy, skin Raman Spectroscopy
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surface enhanced Raman SpectroscopyDiagnostic test
Also called Skin Raman Spectroscopy
Spectral measurements of blood serum were performed on a silver nanoparticle substrate. Each 1.5 μL serum sample was applied to a substrate with a layer of silver nanoparticles and dried . The spectral characteristics of serum were analyzed using an experimental bench consisting of a spectrometric system and a microscope . The spectra were excited by laser module with a center wavelength of 785 nm. Each of the obtained spectra was a discrete set of 1700 parameters .
For skin Raman spectroscopy an experimental portable RS system was used, including a 785 nm diode laser , a portable commercially available Raman probe to filter the collected scattered radiation, and a portable spectrometer (QE65Pro, Ocean optics, Florida, USA). The scattered radiation was collected from the upper 1 to 2 mm thick skin layer. The Raman spectral range was 780-1000 nm with resolution of 0.2 nm. Each spectrum was recorded at an exposure time of 20 seconds with three-fold accumulation.
| Study group | Role | What they receive |
|---|---|---|
| CHD + CHF | Coronary Heart Disease with overt Chronic Heart Failure (200 participants) Receives: Diagnostic Test: surface enhanced Raman Spectroscopy | |
| CHD | Coronary Heart Disease without Chronic Heart Failure (70 participants) Receives: Diagnostic Test: surface enhanced Raman Spectroscopy | |
| NICMP +CHF | Non-Ischemic Cardiomyopathies with overt Chronic Heart Failure (50 participants) Receives: Diagnostic Test: surface enhanced Raman Spectroscopy | |
| VCMP+CHF | Valvular Cardiomyopathies with overt Chronic Heart Failure (40 participants) Receives: Diagnostic Test: surface enhanced Raman Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
record in electronic medical information analitical system(EMIAS)
The initial information of participant's death would be verified by official record
Measured: 01.11.2022-01.05.2024
record in electronic medical information analitical system (EMIAS)
The initial information of participant's cardiovascular death would be verified by official record
Measured: 01/11/2022-01/05/2024
Secondary outcomes (1)
record in electronic medical information analitical system (EMIAS) and history of disease
The initial information of participant's cardiovascular death would be verified by official record . The fact of admittance to hospitals was verified by appropriate documents
Measured: 01/11/2022-01/05/2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 Nov 2022
- Primary completion11 Oct 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samara State Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- City Clinical Hospital No.1 named after N.I. Pirogov
- Responsible party
- Sponsor
- Investigators
- Petr A Lebedev, professor, Principal investigator, chief of therapy chair of professional education department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393595
- Sponsor's protocol ID
- CHF-RS001
- Acronym
- PROMETHEUS
- Status last verified
- Dec 2024
- First submitted
- 26 Apr 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Outcomes in Patients With Chronic Heart Failure Based on Tissue Raman Spectroscopy
- ClinicalTrials.gov ID
- NCT06393595
- Acronym / sponsor ID
- PROMETHEUS / CHF-RS001
- Conditions
- Chronic Heart Failure
- Keywords
- cumulative death, cardiovascular death (CVD), CVD or hospitalization for heart failure exacerbation, surface enhanced Raman Spectroscopy, skin Raman Spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Samara State Medical UniversityUniversity, hospital or other
- Collaborators
- City Clinical Hospital No.1 named after N.I. Pirogov
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 11 Oct 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- Group with CHF based on CHD of both sexes aged 35 to 84 years (200 participants);
- Group with CHD without CHF (70 participants);
- Group with CHF with non-ischemic cardiomyopathies (50 participants);
- 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:
- 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 ).
- 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:
- 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.
- Develop prediction models for total mortality, CV mortality, and CV mortality in combination with hospitalizations for CHD participants with CHF .
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CHD + CHF | – | Diagnostic Test: surface enhanced Raman SpectroscopyCoronary Heart Disease with overt Chronic Heart Failure (200 participants) |
| CHD | – | Diagnostic Test: surface enhanced Raman SpectroscopyCoronary Heart Disease without Chronic Heart Failure (70 participants) |
| NICMP +CHF | – | Diagnostic Test: surface enhanced Raman SpectroscopyNon-Ischemic Cardiomyopathies with overt Chronic Heart Failure (50 participants) |
| VCMP+CHF | – | Diagnostic Test: surface enhanced Raman SpectroscopyValvular Cardiomyopathies with overt Chronic Heart Failure (40 participants) |
Who may qualify
- Ages
- 35 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The researchers included participants from among those hospitalized in the cardiology department of an urban acute care hospital (groups 1,3,4)because of first-diagnosed chronic heart failure or its exacerbation. Group 2 consisted of patients with clinically and instrumentally proven chronic ischemic heart disease without manifestations of CHF also hospitalized. Reasons for hospitalization in this group were related to BP elevation, paroxysms of atrial fibrillation/atrial flutter. Selection into the study was made among consecutively admitted patients, provided that the inclusion criteria were met
Key inclusion criteria (5 listed)
- Group 1(CHD+CHF): clinically evident CHF II-IV NYHA Classes,confirmed by NT-proBNP diagnostic levels. Any form of Coronary Heart Disease :angina pectoris up to and including 2 functional class, previous myocardial infarction, percutaneous coronary intervention or coronary arteries bypass grafts. possible functional insufficiency of A-V valves, arterial hypertension, possibly with chronic atrial fibrillation/atrial fibrillation of any form, ventricular extrasystoles of any class, Hiss bundle branch block not requiring implantation of devices, ability to self-care.
- Group 2(CHD): Any form of Cronic Heart Disease :angina pectoris up to and including 2 functional class, previous myocardial infarction, percutaneous coronary intervention or coronary arteries bypass grafts, possible functional insufficiency of A-V valves of 1 stage, arterial hypertension, possibly with chronic atrial fibrillation/ flatter of any form, ventricular extrasystoles of any class, Hiss bundle branch block not requiring implantation of devices, ability to self-care.
- Group 3 (NICMPs+CHF): clinically evident CHF II-IV NYHA Classes,confirmed by NT-proBNP diagnostic levels without signs of CHD in the history, without violation of coronary anatomy - stenoses (MSCT and coronary angiography). Possible functional insufficiency of A-B valves of the 1st degree, arterial hypertension, possible chronic forms of atrial fibrillation/ flatter, ventricular extrasystoles of any class, blockade of the Hiss legs not requiring implantation of devices, capable of self-care.
- Group 4 (VCMPs+CHF):Valvular acquared cardiomyopathies with clinically evident CHF II-IV NYHA Classes,confirmed by NT-proBNP diagnostic levels without signs of CHD in the history, without violation of coronary anatomy - stenoses (MSCT and coronary angiography). Possible functional insufficiency of A-B valves of the 1st degree, arterial hypertension, possible chronic forms of atrial fibrillation/ flatter, ventricular extrasystoles of any class, blockade of the Hiss legs not requiring implantation of devices, capable of self-care.
- Exclusion Criteria:Exclusion criteria (for groups 1-4): Acute myocardial infarction or unstable angina within the last 6 months, Dementia, lack of signed consent, CKD 4st or higher, tuberculosis, active cancer, liver cirrhosis of infectious etiology, chronic anemia : Hemoglobin less than 95 g/L, inability to self-care, type 1 diabetes mellitus,or insulin-dependent type 2 DM , anticipated heart valve surgery within one year, uncontrolled endocrine disease or malignancy likely to affect prognosis.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surface enhanced Raman SpectroscopyAlso: Skin Raman SpectroscopySpectral measurements of blood serum were performed on a silver nanoparticle substrate. Each 1.5 μL serum sample was applied to a substrate with a layer of silver nanoparticles and dried . The spectral characteristics of serum were analyzed using an experimental bench consisting of a spectrometric system and a microscope . The spectra were excited by laser module with a center wavelength of 785 nm. Each of the obtained spectra was a discrete set of 1700 parameters . For skin Raman spectroscopy an experimental portable RS system was used, including a 785 nm diode laser , a portable commercially available Raman probe to filter the collected scattered radiation, and a portable spectrometer (QE65Pro, Ocean optics, Florida, USA). The scattered radiation was collected from the upper 1 to 2 mm thick skin layer. The Raman spectral range was 780-1000 nm with resolution of 0.2 nm. Each spectrum was recorded at an exposure time of 20 seconds with three-fold accumulation. | Diagnostic test | CHD, CHD + CHF, NICMP +CHF, VCMP+CHF |
Primary outcome
record in electronic medical information analitical system(EMIAS)
Time frame: 01.11.2022-01.05.2024
The initial information of participant's death would be verified by official record
record in electronic medical information analitical system (EMIAS)
Time frame: 01/11/2022-01/05/2024
The initial information of participant's cardiovascular death would be verified by official record
1 secondary outcome
record in electronic medical information analitical system (EMIAS) and history of disease
Time frame: 01/11/2022-01/05/2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Khristoforova YA, Bratchenko LA, Skuratova MA, Lebedeva EA, Lebedev PA, Bratchenko IA. Raman spectroscopy in chronic heart failure diagnosis based on human skin analysis. J Biophotonics. 2023 Jul;16(7):e202300016. doi: 10.1002/jbio.202300016.Link provided by the sponsor.
- Konovalova DY, Lebedev PA, Zakharov VP. Raman spectroscopy of human skin for kidney failure detection. J Biophotonics. 2021 Feb;14(2):e202000360. doi: 10.1002/jbio.202000360.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Chronic Heart Failure
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petr A Lebedev, professor principal investigator
chief of therapy chair of professional education department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure, run by Samara State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
record in electronic medical information analitical system(EMIAS) (time frame: 01.11.2022-01.05.2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.