Actively Recruiting
Arterial Stiffening as a Predictor for Diastolic Cardiac Dysfunction and HFpEF
Led by University Medical Center Goettingen · Updated on 2024-05-09
150
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating patients at risk for heart failure with preserved ejection fraction (HFpEF) to understand how stiffening of the arteries may be linked to the development of heart problems affecting the heart's ability to relax and fill properly. This observational study aims to explore the connection between arterial stiffness and cardiac diastolic dysfunction over time. The research is sponsored by University Medical Center Goettingen and focuses on cardiovascular health in adults, especially those with risk factors like high blood pressure or diabetes. Participants will undergo structured clinical assessments including transthoracic echocardiography and pulse-wave analysis to measure arterial stiffness and heart function. The study will track changes in heart function scores, the onset of HFpEF, and cardiovascular events over a 24-month period. No investigational treatments or medications are administered, as this is an observational study focused on monitoring and data collection. Throughout the study, participants will have evaluations of heart function and related health measures at regular intervals up to 24 months. These include assessments of heart failure scores, blood markers like NT-proBNP, kidney function, and symptoms of heart failure. Researchers will monitor changes in these measures to understand disease progression and cardiovascular health. The study allows adults 18 years and older with certain risk factors to participate, and safety and health will be closely observed during the study period.
CONDITIONS
Brief Title
Arterial Stiffening as a Predictor for Diastolic Cardiac Dysfunction and HFpEF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 60 years or
- Arterial hypertension defined as systolic blood pressure ≥ 140 mmHg or diastolic ≥ 90 mmHg or use of two or more antihypertensive drugs or
- Diabetes mellitus Type I or II or
- Atrial fibrillation or
- Chronic kidney disease with GFR less than 60 ml/min/1.73 m2 or urine albumin ≥ 30mg/24h or albumin-to-creatinine ratio ≥ 30 mg/g or
- Body mass index of 30 kg/m2 or higher or
- New York Heart Association (NYHA) class II or higher or
- E/e' ratio greater than 8
You will not qualify if you...
- Left ventricular ejection fraction less than 50% or
- Significant valve disease of grade III or higher or
- History of interventional or surgical valve repair or
- Regional wall motion abnormalities or
- Respiratory diseases known to cause breathlessness or
- Atrial flutter or fibrillation present during examination or
- Hypertrophic, restrictive, arrhythmogenic, or dilated cardiomyopathies including cardiac amyloidosis, sarcoidosis, or toxic cardiomyopathy or
- History of heart transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 months
Participants are observed to track changes in heart function and related health parameters over time.
Regular visits during the 24 months for assessments
Trial Site Locations
Total: 1 location
1
Universitätsmedizin Göttingen
Göttingen, Lower Saxony, Germany, 37075
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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