Multilevel human HFpEF phenotyping (SFB 1470 - Z02)

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 400

Inclusion Criteria

1) Age = 18 years
2) Written informed consent
3) Presence of signs and symptoms of heart failure corresponding to a NYHA class = 2.
4) Echocardiographically preserved ejection fraction (LVEF = 50%).
5) NTproBNP >125 (SR) or >365 (VHFL) pg/mL or BNP >35 (SR) or >105 (VHL) pg/mL.
6) Existence of structural or functional cardiac changes compatible with LV diastolic dysfunction or elevated left ventricular filling pressures, respectively.
Applicability of at least one of the following echocardiographic or invasive criteria:
- LV mass index = 95 g/m2 (women), >_115 g/m2 (men) and relative wall thickness >0.42
- LA volume index > 34mL/m2 (SR) or > 40 ml/m2 (VHFL).
- E/e' ratio at rest = 13
- PA systolic pressure >35 mmHg (invasive under stress).
- TR velocity at rest > 2.8 m/s (invasive under stress)

Exclusion Criteria

1) Life expectancy < 1 year
2) Lack of consent or ability to give consent.
3) History of heart failure with reduced systolic function (HFmrEF u. HFrEF, LVEF< 50%); exception: acute heart failure, e.g. acute drop in LVEF during episodes of paroxysmal or persistent atrial fibrillation with evidence of preserved LVEF in sinus rhythm
4) Terminal renal failure and/or need for dialysis.
5)
Myocardial infarction (ST-segment elevation myocardial infarction or non-ST-segment elevation myocardial infarction), urgent or elective percutaneous coronary intervention within the past 30 days
6) Cardiac surgery or other major cardiovascular surgery within the past three months
7) Alternative cardiac diagnoses that the investigator believes may be causing the patient's heart failure symptoms (evidence of severe right heart failure in the absence of left ventricular structural changes, specific etiologies such as infiltrative, genetically hypertrophic cardiomyopathy, constrictive pericarditis, sarcoidosis, amyloidosis, other storage diseases, clinically significant congenital heart disease, high-grade valvular vitiation requiring surgical or interventional management).
8) Alternative non-cardiac diagnoses that the investigator believes may be causing the patient's heart failure symptoms such as severe pulmonary disease (e.g., primary pulmonary hypertension, severe COPS GOLD >2) or severe anemia (Hb<10g/dl in men and Hb <9.5g/dl in women).

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiovascular mortality after 10 years

Secondary Outcome Measures

Name	Time	Method
- Cardiovascular hospitalization.<br>- All-cause mortality<br>- Overall rate of cardiovascular hospitalization<br>- Progression of left ventricular ejection fraction (capturing the dynamic process of the disease)<br>- Change in ventilatory efficiency