Identification of new prognostic biomarkers in chronic heart failure: Prospective longitudinal observational cohort study of patients with chronic heart failure and with or without diabetes mellitus

Recruiting

• Conditions: I50; Heart failure; E11; Type 2 diabetes mellitus

• Registration Number: DRKS00025557
• Lead Sponsor: Medizinische Klinik I, Uniklinikum RWTH Aachen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

1. Older than 18 years old
2. Written declaration of consent
3. Persons who are legally competent and mentally able to follow the instructions of the study staff.
4. Chronic heart failure: Symptoms compatible with heart failure with age-dependent and guideline-based elevated NT-proBNP levels and echocardiographic criteria of heart failure and stable clinical course for at least 4 weeks.

Exclusion Criteria

1. Younger than 18 years
2. Pregnant and breastfeeding women (will be asked)
3. Primary valve vitia
4. acute myocarditis
5. Alcohol abuse
6th line after Chemotherapy or radiation therapy (thoracic area)
7. primary cardiomyopathies (except dilated forms)
8. Tachycardia-related and so-called Tako-Tsubo cardiomyopathies
9. with congenital heart defects (GUCH)
10. Type 1 diabetes
11. CDK Stage 5d
12. COPD with chronic home oxygen needs
13. Immobility with dependency

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cardiovascular mortality

Secondary Outcome Measures

Name	Time	Method
• Hospitalization (first and recurring) due to heart failure <br>• Hospitalization (first and recurring) due to any cause <br>• Hospitalization due to fatal and non-fatal pulmonary embolism <br>• Hospitalization due to severe bacterial or viral infection<br>• Time until sepsis occurs<br>• Length of time to non-cardiac death<br>• Time to total mortality<br>• Time to non-fatal heart attack<br>• Time to non-fatal acute coronary syndrome<br>• Time to survived sudden cardiac death<br>• Time to non-fatal end stage renal failure<br>• How long it takes to develop non-steroidal diabetes in patients with prediabetes<br>• Time taken to develop nonsteroidal diabetes in patients with normoglycemia<br>• Time taken to develop non-steroidal prediabetes in patients with normoglycemia<br>• Time taken to develop HFrEF in patients with HFmrEF<br>• Time taken to develop HFrEF in patients with HFpEF<br>• Time taken to develop HFmrEF in patients with HFpEF