I50.19 I27.28
Conditions
Interventions
Group 1: Patients will be followed prospectively for at least one year. The baseline evaluation will consist of ECG, a 6-minute-walk-test (6-MWT) with Borg dyspnea score for determination of exercise
Sponsors
Medizinische Universität Wien, Allgemeines Krankenhaus der Stadt Wien, Universitätsklinik II für Innere Medizin , Abteilung für Kardiologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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 15 • 15>E/e’>8 and NT-proBNP > 220pg/ml 5. Right heart catheter • PCWP = 15 mmHg +/- PAPmean = 25 mmHg
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be a combined endpoint consisting of clinical worsening or death. Clinical worsening is defined as hospitalization for heart failure, renal failure, hypotension or cardiogenic shock. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Austria
Contacts
Public ContactDiana Bonderman
Medizinische Universität Wien, Allgemeines Krankenhaus der Stadt Wien, Universitätsklinik II für Innere Medizin , Abteilung für Kardiologie
Outcome results
None listed