Heart FailureODT-CRSNCT05397392
Research on Optimal Diagnosis and Treatment of Cardiorenal Syndrome
An observational study of Heart Failure and Kidney Diseases, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
To estimate the characteristics, pathogenesis, risk factors and intervention measures for different stages of heart and kidney diseases, and to optimize the curative effects of different treatment schemes Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Kidney Diseases, Kidney Injury
- What is being tested?
- guideline recommended routine treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from a tertiary hospital
Who may be able to join
- Patients meet the diagnosis of various types of cardiorenal syndrome according to the classification standards of various types formulated by KDIGO and ADQI expert consensus. Different syndromes were identified and classified into five subtypes. Acute CRS (type 1): acute worsening of heart function (AHF-ACS) leading to kidney injury and/or dysfunction. Chronic cardio-renal syndrome (type 2): chronic abnormalities in heart function (CHF-CHD) leading to kidney injury and/or dysfunction. Acute reno-cardiac syndrome (type 3): acute worsening of kidney function (AKI) leading to heart injury and/or dysfunction. Chronic reno-cardiac syndrome (type 4): chronic kidney disease leading to heart injury, disease, and/or dysfunction. Secondary CRS (type 5): systemic conditions leading to simultaneous injury and/or dysfunction of heart and kidney.
Who cannot join
- Pregnant or breastfeeding women; Female patients with recent birth plans; Patients who cannot follow up on medications.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
To estimate the characteristics, pathogenesis, risk factors and intervention measures for different stages of heart and kidney diseases, and to optimize the curative effects of different treatment schemes
Read the detailed description
Cardiorenal syndrome is a clinical syndrome caused by acute or chronic injury of one of the heart and kidney resulting to acute or chronic dysfunction of the other organ. In recent years, the morbidity of cardiorenal syndrome has increased rapidly in China. Its condition is complex and difficult to treat. Due to the lack of studies specifically targeting the cardiorenal syndrome population, there is no systematic in-depth understanding of the pathogenesis and risk factors of this kind of disease. In clinic, the course of various types of cardiorenal syndrome is complex and difficult to be summarized into a specific type. Therefore, we intend to conduct a clinical systematic observation and research on such patients so as to optimize a more reasonable treatment scheme.
- Conditions
- Heart Failure, Kidney Diseases, Kidney Injury, Heart Valve Diseases, Dialysis; Complications, Coronary Heart Disease
- Being tested
- guideline recommended routine treatment
- Medical subject headings
- Heart Failure, Kidney Diseases, Heart Valve Diseases, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guideline recommended routine treatmentOther
| Study group | Role | What they receive |
|---|---|---|
| acute kidney injury | Acute kidney injury caused by heart disease or cardiac dysfunction due to acute renal damage Receives: Other: guideline recommended routine treatment | |
| chornic kidney disease | Chornic kidney injury caused by heart disease or cardiac dysfunction due to chronic kidney disease Receives: Other: guideline recommended routine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization due to worsening of renal or cardiac function
eGFR continuously decreased by more than 25% within one year; NYHA cardiac function class III or above requires intravenous pharmacological agents; deterioration of cardiac or kidney function requiring dialysis
Measured: 1 year
All-cause deaths
Deaths due to disease progression
Measured: 1 year
Secondary outcomes (2)
End-stage renal disease requires maintenance dialysis
eGFR<15ml/min, combined with one of the following conditions: 1. Uremia symptoms that cannot be alleviated by limiting protein intake; 2. Hyperkalemia that is difficult to correct; 3. Progressive metabolic acidosis that is difficult to control; 4. Uncontrollable water and sodium retention, combined with congestive heart failure or acute pulmonary edema; 5. Uremic pericarditis; 6. Uremic encephalopathy and progressive neuropathy.
Measured: 1 year
Acute kidney injury
increase in Scr ≥0.3 mg/dL (26.5 μmol/L) within 48 h, or increase in Scr ≥1.5 times baseline in 7 days, or urine volume <0.5 mL/kg/h for 6 h.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study startJan 2016
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397392
- Sponsor's protocol ID
- KY20220425-02
- Acronym
- ODT-CRS
- Status last verified
- Apr 2022
- First submitted
- 26 May 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Optimal Diagnosis and Treatment of Cardiorenal Syndrome
- ClinicalTrials.gov ID
- NCT05397392
- Acronym / sponsor ID
- ODT-CRS / KY20220425-02
- Conditions
- Heart Failure, Kidney Diseases, Kidney Injury, Heart Valve Diseases, Dialysis; Complications, Coronary Heart Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 31 May 2022 (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.
To estimate the characteristics, pathogenesis, risk factors and intervention measures for different stages of heart and kidney diseases, and to optimize the curative effects of different treatment schemes
Detailed description
Cardiorenal syndrome is a clinical syndrome caused by acute or chronic injury of one of the heart and kidney resulting to acute or chronic dysfunction of the other organ. In recent years, the morbidity of cardiorenal syndrome has increased rapidly in China. Its condition is complex and difficult to treat. Due to the lack of studies specifically targeting the cardiorenal syndrome population, there is no systematic in-depth understanding of the pathogenesis and risk factors of this kind of disease. In clinic, the course of various types of cardiorenal syndrome is complex and difficult to be summarized into a specific type. Therefore, we intend to conduct a clinical systematic observation and research on such patients so as to optimize a more reasonable treatment scheme.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acute kidney injury | – | Other: guideline recommended routine treatmentAcute kidney injury caused by heart disease or cardiac dysfunction due to acute renal damage |
| chornic kidney disease | – | Other: guideline recommended routine treatmentChornic kidney injury caused by heart disease or cardiac dysfunction due to chronic kidney disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from a tertiary hospital
Key inclusion criteria (1 listed)
- Patients meet the diagnosis of various types of cardiorenal syndrome according to the classification standards of various types formulated by KDIGO and ADQI expert consensus. Different syndromes were identified and classified into five subtypes. Acute CRS (type 1): acute worsening of heart function (AHF-ACS) leading to kidney injury and/or dysfunction. Chronic cardio-renal syndrome (type 2): chronic abnormalities in heart function (CHF-CHD) leading to kidney injury and/or dysfunction. Acute reno-cardiac syndrome (type 3): acute worsening of kidney function (AKI) leading to heart injury and/or dysfunction. Chronic reno-cardiac syndrome (type 4): chronic kidney disease leading to heart injury, disease, and/or dysfunction. Secondary CRS (type 5): systemic conditions leading to simultaneous injury and/or dysfunction of heart and kidney.
Key exclusion criteria (1 listed)
- Pregnant or breastfeeding women; Female patients with recent birth plans; Patients who cannot follow up on medications.
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 |
|---|---|---|
| guideline recommended routine treatment | Other | acute kidney injury, chornic kidney disease |
Primary outcome
Hospitalization due to worsening of renal or cardiac function
Time frame: 1 year
eGFR continuously decreased by more than 25% within one year; NYHA cardiac function class III or above requires intravenous pharmacological agents; deterioration of cardiac or kidney function requiring dialysis
All-cause deaths
Time frame: 1 year
Deaths due to disease progression
2 secondary outcomes
End-stage renal disease requires maintenance dialysis
Time frame: 1 year
Acute kidney injury
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
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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.
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 Heart Failure and Kidney Diseases, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 2 Jun 2022. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yue Zhou, master of medicine (+8615380998793, 56005460@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization due to worsening of renal or cardiac function (time frame: 1 year). 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 2 Jun 2022.