The Hong Kong Diastolic Heart Failure Study: a Randomized Control Trial of Diuretics, Irbesartan and Ramipril on Quality of Life, Exercise Capacity, Left Ventricular Global and Regional Function in Heart Failure With a Normal Ejection Fraction.

Abstract

Background Although heart failure with a preserved or normal ejection fraction (HFNEF or diastolic heart failure) is common, treatment outcomes on quality of life and cardiac function are lacking. We assessed the effect of renin-angiotensin blockade by irbesartan or rampril in combination with diuretics on quality of life (QoL), regional and global systolic and diastolic function in HFNEF patients.

Methods 150 patients with HFNEF (LVEF >45%) were randomized to (1) diuretics alone, (2) diuretics plus irbesartan, or (3) diuretics plus ramipril. QoL, 6-minute walk test (6MWT) and Doppler echocardiography were performed at baseline, 12, 24 and 52 weeks.

Resutls The QoL score improved similarly in all 3 groups by 52 weeks (-46%, 51%, and 50% respectively, all p<0.01), although 6MWT increased only slightly (average +3-6%). Recurrent hospitalization rates were equal in all groups (10-12% in 1 year). At 1 year, LV dimensions or LVEF were unchanged in any group, though both systolic and diastolic blood pressures were lowered in all three groups from 4 weeks onwards. At baseline both mean peak systolic (Sm) and early diastolic (Em) mitral annulus velocities were reduced and increased slightly in the diuretic plus irbesartan (Sm 4.5±0.17 to 4.9±0.16 cm/sec; Em 3.8±0,25 to 4.2±0.25 cm/sec) and ramipril (Sm 4.5±0.24 to 4.9±0.2 cm/sec; Em 3.3±0.25 to 4.04±0.32 cm/sec) groups (both p<0.05). NT-proBNP levels were raised at baseline (595±905; range 5-4748 pmol/l) and fell in the irbesartan (-124±302 pmol/l, p=0.01) and ramipril (-173±415, p=0.03) groups only.

Conclusions In this typically elderly group of HF patients with normal LVEF,diuretic therapy significantly improved symptoms and neither irbesartan nor ramipril had a significant additional effect. However, diuretics in combination with irbesartan or ramipril marginally improved LV systolic and diastolic longitudinal LV function, and lowered BNP over one year.