Predictors of outcome in heart failure with preserved ejection fractio

Recruiting

Conditions: I50.19
I27.28

Registration Number: DRKS00004573

Lead Sponsor: Medizinische Universität Wien, Allgemeines Krankenhaus der Stadt Wien, Universitätsklinik II für Innere Medizin , Abteilung für Kardiologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 350

Inclusion Criteria

Inclusion Criteria:

1. Age = 18 years
2. written informed consent
3. symptoms or signs of heart failure (NYHA > I)
4. transthoracic echocardiography:
•LVEF > 50 %
•LVEDVI < 97ml/m2
•E/E' > 15
•15>E/e’>8 and NT-proBNP > 220pg/ml
5. Right heart catheter
•PCWP = 15 mmHg +/- PAPmean = 25 mmHg

Exclusion Criteria

Exclusion Criteria:

1. Inability or unwillingness to perform any of the diagnostic tests and to participate in follow-up visits
2. Left ventricular ejection fraction =50%
3. Significant valvular heart disease
4. Congenital heart disease
5. Significant coronary artery disease requiring percutaneous coronary intervention or aorto-coronary bypass surgery
6. Left ventricular diastolic dysfunction without symptoms or signs of heart failure, such as presence or history of dyspnea at rest, fluid retention, jugular vein distension
7. Severe chronic renal insufficiency (GFR <30 ml/min)
8. Pregnancy
9. Bronchial asthma or COPD with Forced Expiratory Volume in one second (FEV1) <60% predicted
10. Restrictive lung disease with Total Lung Capacity <60% predicted
11. Severe congenital abnormalities of the lungs, thorax, or diaphragm
12. Abnormalities in blood gases (measured capillary or arterial): SaO2 <88% or PaO2 <55 mmHg

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure will be a combined endpoint consisting of clinical worsening or death. Clinical worsening is defined as hospitalization for heart<br>failure, renal failure, hypotension or cardiogenic shock.

Secondary Outcome Measures

Name	Time	Method
The secondary outcome measure will be changes in exercise capacity as measured by the 6-MWT (at baseline of the study and in six-month-intervals), time to clinical worsening and death.