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Investigation on the Association between R loop Level in Heart Tissue and Heart Failure Phenotypes

Investigation on the Association between R loop Level in Heart Tissue and Heart Failure Phenotypes

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600116707
Enrollment
Unknown
Registered
2026-01-14
Start date
2024-03-15
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure with preserved ejection fraction

Interventions

HFpEF subgroup:NA
HFrEF Subgroup:NA
Control group:NA

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion Criteria for HFpEF Group: 1. previous or current clinical symptoms or signs of heart failure; 2. an echocardiogram within 12 months prior to myocardial biopsy or cardiac surgery showing LVEF >= 50%; 3. objective evidence of left ventricular diastolic dysfunction or elevated filling pressure, meeting at least two of the following: echocardiographic structural abnormalities (left ventricular hypertrophy or left atrial enlargement) or diastolic dysfunction (E/e’ > 9), elevated serum natriuretic peptides (BNP >= 35 pg/mL or NT-proBNP >= 125 pg/mL in sinus rhythm; BNP >= 105 pg/mL or NT-proBNP >= 365 pg/mL in atrial fibrillation), or hemodynamic evidence of elevated left ventricular filling pressure (resting PAWP >= 15 mmHg or post-exercise PAWP >= 25 mmHg); 4. at least one of the following: age > 60 years, hypertension, coronary artery disease, atrial fibrillation, pulmonary hypertension (PASP > 35 mmHg), obesity (BMI > 28 kg/m²), diabetes, chronic kidney disease, or chronic obstructive pulmonary disease. Inclusion Criteria for HFrEF Group: 1. previous or current clinical symptoms or signs of heart failure; 2. an echocardiogram within 12 months prior to myocardial biopsy or cardiac surgery demonstrating a documented LVEF 60 years, hypertension, coronary artery disease, atrial fibrillation, pulmonary hypertension (PASP > 35 mmHg), obesity (BMI > 28 kg/m²), diabetes, chronic kidney disease, or chronic obstructive pulmonary disease. Inclusion Criteria for the National Brain Bank Control Group: Control samples were provided by the National Human Brain Bank for Development and Function (Chinese Academy of Medical Sciences & Peking Union Medical College). 1. under 70 years of age (due to the high prevalence of comorbid diastolic dysfunction and HFpEF in advanced age), 2. whose cause of death was non-cardiac (specifically excluding sudden cardiac death, myocardial infarction, heart failure, or cardiac arrest; priority was given to cases of accidental death).

Exclusion criteria

Exclusion criteria: Exclusion Criteria for HFpEF Group: 1. a clinical history of LVEF < 40%; 2. heart failure caused by specific etiologies as confirmed by clinical evaluation or myocardial biopsy pathology, including infiltrative cardiomyopathies (such as cardiac amyloidosis, glycogen storage disease, or hemosiderosis), myocarditis (e.g., infectious, autoimmune, inflammatory myopathy, eosinophilic myocarditis, or immune therapy-related myocarditis), constrictive pericarditis, or other specific cardiomyopathies (such as hypertrophic obstructive cardiomyopathy, arrhythmogenic right ventricular dysplasia/cardiomyopathy, or hereditary cardiomyopathies); 3. a history of heart transplantation. Exclusion Criteria for HFrEF Group: 1. heart failure determined by clinical evaluation to be caused by systemic conditions, including severe systemic infection, highly active autoimmune disease, uncontrolled hyperthyroidism, or severe anemia; 2. heart failure due to specific etiologies confirmed clinically or by myocardial biopsy, such as infiltrative cardiomyopathies (e.g., cardiac amyloidosis, glycogen storage disease, hemosiderosis), myocarditis (including infectious, autoimmune, inflammatory myopathy, eosinophilic, or immune therapy-related myocarditis), constrictive pericarditis, or other specific cardiomyopathies (such as hypertrophic obstructive cardiomyopathy, arrhythmogenic right ventricular dysplasia/cardiomyopathy, or hereditary cardiomyopathies). 3. a history of heart transplantation. Exclusion Criteria for control group: 1. a documented clinical history of heart failure or cardiomyopathy prior to death, 2. severe systemic inflammatory conditions (such as septic shock, sepsis, or active autoimmune diseases), cerebrovascular disease (e.g., atherosclerotic cerebral infarction), or any other condition deemed clinically inappropriate for inclusion as controls upon medical evaluation.

Design outcomes

Primary

MeasureTime frame
R loop level in heart tissue;

Countries

China

Contacts

Public ContactYaqun Teng

Peking Union Medical College Hospital

tengyaqun@126.com+86 186 1815 9631

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026