Exploring heart failure with preserved ejection fraction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect a comprehensive dataset of patients diagnosed with heart failure with preserved ejection fraction (HFpEF). It focuses on deep phenotyping to categorize the spectrum and subtypes of HFpEF, utilizing advanced biochemical and functional assessments. By understanding the determinants influencing prognosis, the study seeks to enhance individualized treatment planning for patients suffering from this condition. The findings could lead to improved management strategies and better outcomes for those affected by HFpEF.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Hospitalisation for heart failure or debilitating dyspnoea (NYHA II-IV) and a diagnosis of HFpEF.
* Left ventricular ejection fraction (LVEF) \>40% in the preceding 12 months or during a period of hospitalisation as determined by either cardiac ultrasound, MRI, left ventricular echocardiography, or isotope imaging.
* NTproBNP \> 300 pg/ml (or BNP \> 100 pg/ml) during hospitalisation or NTproBNP \> 125 pg/ml in outpatients.
* Impaired myocardial relaxation (diastolic dysfunction) as determined by tissue doppler imaging (TDI: lateral mitral annulus velocity, lat E\' \<9cm/s or septal annulus velocity, sept E\' \<8 cm/s)
* Both previously undiagnosed, de-novo heart failure patients and patients admitted to hospital for acute exacerbation of known heart failure will be included in the study.

Exclusion Criteria:

* Age \>85 years
* Significant aortic valve stenosis (AVA ≤1.0 cm2)
* Primary (structural) mitral valve disease with grade III-IV insufficiency or significant stenosis (MVA\<1.5 cm2)
* Other severe valvular defect (e.g. secondary severe mitral or severe tricuspid insufficiency)
* Previous LVEF \< 40% (HFrEF or HF with improved EF)
* Recent acute coronary syndrome (\< 3 months) or myocardial infarction with ST elevations (STEMI) within 12 months
* Previous open heart surgery (CABG/valvular) or percutaneous valvular interventio
* Previously known specific myocardial disease (hypertrophic cardiomyopathy, non-compaction cardiomyopathy (LVNC), right ventricular arrhythmogenic cardiomyopathy (ARVC), cardiac amyloidosis, cardiac sarcoidosis, haemochromatosis)
* End-stage renal disease (eGFR \<15 ml/min or dialysis treatment, previous kidney transplantation)
* Significant physical disability, mobility limitation, or dependence on another person for assistance (patient is not self-sufficient) limits participation in the study

Where it's running

• Helsinki University Hospital
  Helsinki, Finland Recruiting

Study contacts

• Study coordinator: Johan Lassus, Md.; Ph.D
• Email: johan.lassus@hus.fi
• Phone: +358 50 4284708

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Remote rehabilitation for HFpEF patients using telerehabilitation

  A home-based telerehabilitation program is being tested to see if it is safe and helpful for people with heart failure with preserved ejection fraction.

  Recruiting at 3 sites American Heart of Poland · Chrzanów and 2 other locations · NCT07918209

• EDG-15400 in adults with HFpEF: a phase 2 study

  This phase 2 study tests different doses of EDG-15400 against placebo in adults with HFpEF to see if it is safe and tolerable.

  Recruiting at 4 sites Phase 2 Edgewise Therapeutics, Inc. · Birmingham, Alabama and 27 other locations · NCT07795814

• Incretin therapy with tirzepatide for obesity-related HFpEF

  A 15-month study will test whether tirzepatide helps people with obesity and HFpEF by reducing plasma volume.

  Recruiting Phase 4 Columbia University · New York, New York · NCT07554638

• Boosted exercise with group coaching for HFpEF

  This trial tests a blended, guided exercise program with group coaching and remote monitoring to see if it helps older adults with HFpEF improve activity and health at a lower cost.

  Recruiting Wake Forest University Health Sciences · Winston-Salem, North Carolina · NCT07413198

• Exercise cardiac MRI for heart failure with preserved ejection fraction

  This study will try low-field exercise cardiac MRI to see if it can diagnose, describe, and predict risk in people with HFpEF compared with those who have non-cardiac breathlessness and healthy volunteers.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07401771

• HRS-1893 for heart failure with preserved ejection fraction

  This trial will test whether HRS-1893 is safe and tolerable in adults aged 40 and older who have heart failure with preserved ejection fraction.

  Recruiting Phase 2 Shandong Suncadia Medicine Co., Ltd. · Shanghai, Shanghai Municipality · NCT07269717

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.