Overview

Inhaled Iloprost and Exercise Hemodynamics and Ventricular Performance in Heart Failure With Preserved Ejection Fraction

Status:
Unknown status
Trial end date:
2020-01-01
Target enrollment:
0
Participant gender:
All
Summary
BACKGROUND There is no effective medical treatment for heart failure with preserved ejection fraction (HFpEF). Increases in pulmonary capillary wedge pressure (PCWP) develop in patients with HFpEF. Prostacyclin analogo can possible reduced PA pressure along with PWCP pressure, as with exercise. OBJECTIVES This study try to determine whether inhlalation of iloprost improves exercise hemodynamics and cardiac reserve in HFpEF. METHODS In a double-blind, randomized, placebo-controlled, parallel-group trial, subjects with HFpEF underwent invasive cardiac catheterization with simultaneous expired gas analysis at rest and during exercise, before and 15 min after treatment with either inhaled iloprost or matching placebo.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Taiwan University Hospital
Treatments:
Iloprost
Criteria
Inclusion Criteria:

1. presence of typical HF symptoms and signs

2. LV ejection fraction ≥ 50

3. elevated levels of NT-proBNP (at least >125 pg/ml)

4. echocardiographic structural (a left atrial volume index > 34 mL/m2 or a left
ventricular mass index ≥115 g/m2 for males and ≥95 g/m2 for females) or functional
alterations (E/e'≥13 and a mean e' septal and lateral wall < 9 cm/s).

Exclusion Criteria:

1. chronic renal failure (creatinine > 250 μmol/L)

2. significant hepatic disease, significant coronary artery disease (CAD) (coronary
artery stenosis >70% without intervention or positive stress test),

3. secondary hypertension,

4. pericardial disease

5. significant valvular heart disease (>mild stenosis, >moderate regurgitation),

6. active cancer,

7. cor pulmonale

8. congenital heart disease

9. high-output heart failure

10. subjects receiving long-term treatment with phosphodiesterase 5 in-hibitors

11. chronic atrial fibrillation.