Status:
COMPLETED
Safety and Efficacy of Bosentan in Patients With Diastolic Heart Failure and Secondary Pulmonary Hypertension
Lead Sponsor:
University Teaching Hospital Hall in Tirol
Conditions:
Heart Failure, Diastolic
Hypertension, Pulmonary
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Heart failure is a major medical and socioeconomic problem in western industrial countries, especially with aging populations. Heart failure with normal left ventricle systolic function (heart failure...
Detailed Description
Heart Failure with preserved ejection fraction is with more than 50% of cases the most common form of heart failure. Typically patients are elderly women with arterial hypertension. Mortality, hospita...
Eligibility Criteria
Inclusion
- Clinically signs or history of congestive heart failure NYHA II-III (Fatigue, dyspnea on exertion, lung crepitations, pulmonary edema, ankle and or lower leg swelling, jugular pressure enhancement, hepatomegaly)
- Echocardiographic signs of diastolic dysfunction (heart failure with normal ejection fraction)
- Right ventricle enlargement with pulmonary hypertension
- 6 minute walking distance \> 150 m \< 400 m
- Right Heart Catheterization: Mean PAP \> 25 mmHg, PCWP \> 15 mmHg
- Echocardiographic requirements for definition of heart failure with normal ejection fraction
- E/E' \> 15, or
- E/E' \> 8 + NTpBNP \> 220 pg/ml, or
- E/E' \> 8 + E:A \< 0.5 + DT \> 280 ms or
- Ard-Ad \> 30 ms or
- atrial enlargement or
- atrial fibrillation
- NTpBNP \> 220 pg/ml + combination
- IVRT - IVRTm \< 0 septal und lateral
- Echocardiographic requirements for pulmonary hypertension and right ventricle dysfunction
- RVEDD \> 30 mm short axis parasternal, and
- one of the following:
- Tricuspid valve regurgitation velocity (TRV) \> 3 m/s;
- RV-annular systolic velocity \< 10 cm/sec (TDI)
- TAPSE \< 18 mm
Exclusion
- Patients who are not on guideline conform treatments for cardiovascular disease.
- Left ventricle systolic dysfunction (EF \< 50 %), aortic stenosis with peak gradient (instantane) \> 40 mm Hg,moderate and severe aortic insufficiency
- moderate and severe mitral regurgitation,
- acute coronary disease, stable coronary artery disease or peripheral vascular disease limiting exercise.
- Other causes of pulmonary - artery - hypertension:
- relevant obstructive ventilatory disease \> grade II (lung functions tests)
- collagen disease (Tests: MSCT and ANA, ANCA),
- chronic thrombo- embolic pulmonary arterial hypertension (MSCT),
- sleep disorder.
- HIV, HCV, HBV infection.
- Drug related PAH.
- Orthopaedic disease, immobility, inability to perform 6MWT and cancer.
- Liver disease Child-Pugh B and C, three fold above normal elevated liver enzymes,
- anaemia Hb \< 10 mg/dl,
- other specific treatment of pulmonary arterial hypertension including other endothelin receptor blockers, phosphodiesterase inhibitors, prostaglandins and L-arginin
- drug therapy with glibenclamide, rifampicin, tacrolimus, sirolimus, cyclosporine A
- known adverse reactions to bosentan and
- pregnancy and lactation
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00820352
Start Date
January 1 2009
End Date
June 1 2014
Last Update
June 30 2014
Active Locations (7)
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1
Hospital Mostviertel Waidhofen/Ybbs
Waidhofen an der Thaya, Lower Austria, Austria, 3340
2
University Teaching Hospital Hall i.T.
Hall I. T., Tyrol, Austria, 6060
3
University Teaching Hospital of the Elisabethinen, Linz
Linz, Upper Austria, Austria, 4010
4
Hospital Wels/Grieskirchen
Wels, Upper Austria, Austria, 4600