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

niversitätslehrkrankenhaus Hall in Tirol0 个研究点开始时间: 2008年9月17日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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

•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.

发起方

niversitätslehrkrankenhaus Hall in Tirol