Endothelin Receptor Blockade in Heart Failure with Diastolic Dysfunction and Pulmonary Hypertension Randomisierte, placebokontrollierte, multizentrische, doppel- blinde Pilotstudie zur Untersuchung der Wirksamkeit, Sicherheit und Verträglichkeit von Bosentan bei der Behandlung von Pati-enten/innen mit diastolischer Herzinsuffizienz und sekundärer pulmonaler Hypertension (PH) - BADDHY

Active, not recruiting

• Conditions: Heart failure with normal left ventricle systolic function (HFNEF) are common causes of hospitalisation mainly in the elderly population and are frequently associated with pulmonary hypertension. It is commonly seen, that patients with left heart disease and pulmonary hypertension with right ventricle dysfunction have a worse prognosis. The medical condition to be investigated is HFNEF (Ejection fraction > 50%) and secondary pulmonary hypertension.; MedDRA version: 9.1Level: LLTClassification code 10000158Term: Abnormal liver function tests; MedDRA version: 9.1Level: LLTClassification code 10019171Term: Hb decreased; MedDRA version: 9.1Level: LLTClassification code 10005890Term: Body fluid retention; MedDRA version: 9.1Level: LLTClassification code 10019211Term: Headache; MedDRA version: 9.1Level: LLTClassification code 10040850Term: Skin flushed; MedDRA version: 9.1Level: LLTClassification code 10024127Term: Leg edema; MedDRA version: 9.1Level: LLTClassification code 10014264Term: Edematous weight gain; MedDRA version: 9.1Level: LLTClassification code 10017884Term: Gastrooesophageal reflux

• Registration Number: EUCTR2008-005514-40-AT
• Lead Sponsor: niversitätslehrkrankenhaus Hall in Tirol

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) Screening phase
a)Clinically signs or history of congestive heart failure NYHA II-III: (Fatigue, dyspnoea on excertion, lung crepitations, pulmonary oedema, ankle and or lower leg swelling, jugular pressure enhancement, hepatomegaly)
b)Echocardiographic signs of diastolic dysfunction: Echocardiographic requirements for definition of heart failure with normal ejection fraction
?E/E` > 15
?E/E` > 8 + NTpBNP > 220 pg/dl
?E/E` > 8 + E:A < 0.5 + DT > 280 ms or Ard-Ad > 30 ms or atrial enlargement or atrial fibrillation
?NTpBNP > 220 + combination 3.)
?IVRT – IVRTm < 0 septal und lateral
c)Right ventricle enlargement with pulmonary hypertension: 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-anular systolc velocity < 10 cm/sec (TDI)
?TAPSE < 18 mm
d)6 minute walking distance > 150 m < 400 m

2) Randomisation Phase
a)Right Heart Catheterization:
?Mean PAP > 25 mmHg
?PCWP > 15 mmHg

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients who are not on guideline conform treatments for cardio-vascular disease.
Left ventricle systolic dysfunction (EF < 50 %), aortic stenosis with peak gradient (instantane) > 40 mm Hg, 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 > stage II (lung function tests for obstructive ventilation disturbances) 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, drug therapy with cyclosporine A , tacrolimus, Sirolimus, Rifampicin and Glibenclamide; other specific therapies treating pulmonary hypertension, known adverse reactions to bosentan and pregnancy. Patients with child bearing potential need to be tested for pregnancy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified