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Search / Trial NCT05479669

Value of Intense Phenotyping in Heart Failure With Preserved Ejection Fraction

Launched by UNIVERSITY MEDICAL CENTER GRONINGEN · Jul 26, 2022

Trial Information

Current as of July 25, 2025

Recruiting

Keywords

Heart Failure With Preserved Ejection Fraction H Fp Ef Cardiac Mri 99m Tc Hdp Scan

ClinConnect Summary

This clinical trial is studying a condition called heart failure with preserved ejection fraction (HFpEF), which means that the heart is not pumping properly despite having a normal amount of blood. The goal of the study is to understand better how different factors—like medical history, heart imaging, and blood tests—can help predict the risk of serious outcomes, like death or hospital visits, for patients with this condition. Researchers hope that by identifying these risk factors, they can improve care for patients with HFpEF.

To participate in the trial, individuals need to be over 18 years old and have moderate to severe heart failure symptoms. They should have been hospitalized or visited an emergency room for heart failure treatment recently. Additionally, their heart function must meet certain criteria, including a specific heart size and certain levels of heart-related biomarkers in their blood. Participants will receive careful monitoring and assessments during the study, which could help contribute to better understanding and treatment for others with heart failure in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Clinical criteria:
  • 1. Age \>18 years
  • 2. Written informed consent
  • 3. HF with moderate to severe symptoms NYHA II or III
  • 4. Hospitalization or emergency room visit for HF or symptom relief with diuretics
  • 5. Sinus rhythm or AF
  • Echocardiographic criteria:
  • 1. LVEF \>0.40
  • 2. Left atrial size (volume ≥29 mL/m2 or LA parasternal diameter ≥45), or left ventricular hypertrophy (septal thickness or posterior wall thickness ≥11 mm) or LV diastolic dysfunction (E/e' ≥13 or mean e' septal and lateral wall \<9 cm/s).
  • Biomarker criteria:
  • 1. BNP \>31ng/L or NT-pro-BNP\>125ng/L if sinus rhythm
  • 2. BNP \>75ng/L or NT-pro-BNP\>300ng/L if atrial fibrillation
  • Exclusion Criteria:
  • 1. Patients unwilling or unable to sign informed consent
  • 2. Patients with a pacemaker or ICD
  • 3. Indication for ICD therapy according to the ESC guidelines
  • 4. Life expectancy of less than one year
  • 5. Significant coronary artery disease or myocardial infarction \< 3 months
  • 6. Complex congenital heart disease
  • 7. Pregnancy

About University Medical Center Groningen

University Medical Center Groningen (UMCG) is a leading academic medical center in the Netherlands, renowned for its commitment to innovative research, high-quality patient care, and extensive education in the medical field. As a prominent sponsor of clinical trials, UMCG leverages its multidisciplinary expertise and state-of-the-art facilities to advance medical knowledge and improve therapeutic outcomes. The center fosters collaboration among researchers, healthcare professionals, and industry partners, aiming to translate scientific discoveries into effective treatments that enhance patient health and well-being. With a focus on ethical standards and regulatory compliance, UMCG is dedicated to conducting clinical trials that contribute to the advancement of medicine and the betterment of society.

Locations

Groningen, , Netherlands

Patients applied

0 patients applied

Trial Officials

Michiel Rienstra, MD PhD

Principal Investigator

University Medical Center Groningen

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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