RecruitingNot Applicable

Arterial Stiffening as a Predictor for Diastolic Cardiac Dysfunction and HFpEF

Germany150 participantsStarted 2024-02-23

Plain-language summary

Patients at risk for developing heart failure with preserved ejection fraction (HFpEF) will undergo a structured clinical assessment, transthoracic echocardiography and pulse-wave analysis to investigate the association of arterial stiffening and the development of cardiac diastolic dysfuntion and HFpEF.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: One or more of the following criteria: * Age \> 60 years * Arterial hypertension (RR systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg or ≥ 2 antihypertensive drugs) * Diabetes mellitus Type I or II * Atrial fibrillation * Chronic kidney disease (GFR \< 60 ml/min/1,73 m2 or urine albumin ≥ 30mg/24h or ACR ≥ 30 mg/g) * BMI ≥ 30 kg/m2 * NYHA ≥ II * E/e' \> 8 Exclusion Criteria: * Left ventricular ejection fraction \< 50 % * Significant valve disease (Grade III or higher) * History of interventional or surgical valve repair * Regional wall motion abnormalities * Respiratory diseases as a known cause for dyspnea * Atrial flutter or fibrillation during examination * Hypertrophic/restrictive/arrhythmogenic/dilatative cardiomyopathies including cardiac amyloidosis or sarcoidosis and toxic cardiomyopathy * History of heart transplantation

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in HFA-PEFF-Score

Timeframe: 24 months

Development of HFpEF

Timeframe: 24 months

Composite endpoint cardiovascular events

Timeframe: 24 months

Trial details

NCT IDNCT06208007

SponsorUniversity Medical Center Goettingen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-01

View on ClinicalTrials.gov More Heart Failure With Preserved Ejection Fraction trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.