Key result
Hydralazine-isosorbide dinitrate did not significantly improve 6-minute walk test distance compared with standard of care at 6 months (mean difference 27 m, 95% CI -12 to 66) in patients with cardiorenal syndrome.
Why the study?
Cardiorenal syndrome has high morbidity and mortality, and hydralazine-isosorbide dinitrate may be used in renal failure and improve exercise capacity in heart failure.
Does the addition of hydralazine-isosorbide dinitrate to standard medical therapy improve exercise capacity in patients with cardiorenal syndrome?
RCT (n=44)
Single-blind
Permuted block randomization with stratification by centre
Yes
Does the addition of hydralazine-isosorbide dinitrate to standard medical therapy improve exercise capacity in patients with cardiorenal syndrome?
The addition of hydralazine-isosorbide dinitrate to standard medical therapy in Asian patients with cardiorenal syndrome did not significantly improve exercise capacity and was limited by poor tolerability.
Does not support adding H-ISDN to improve exercise capacity in cardiorenal syndrome; leaves open questions on tolerability and alternative approaches.
Aims Cardiorenal syndrome (CRS) is a common problem of great morbidity and mortality. Hydralazine–isosorbide dinitrate (H-ISDN) may be used in renal failure and may improve exercise capacity in heart failure (HF). Our proof-of-concept study aimed to evaluate early evidence of efficacy, safety, and feasibility of H-ISDN compared with standard of care in CRS. Methods and results This multi-centre, single-blind, randomized trial in Singapore enrolled CRS patients, defined as chronic HF with concomitant renal failure [estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2]. The primary outcome was 6 min walk test (6MWT) distance measured at 6 months. Secondary outcomes included study feasibility; efficacy outcomes which included renal, cardiac, and endothelial functions, health-related quality of life using Short Form-36, clinical outcomes; and adverse events. Forty-four patients [71 ± 10 years; 75% male; median (inter-quartile range) N-terminal prohormone brain natriuretic peptide 1346 (481–2272) pg/mL] with CRS (left ventricular ejection fraction 42 ± 12% and eGFR 46 ± 15 ml/min/1.73 m2) were randomized into two equal groups. Of these, 39 (89%) had hypertension, 27 (61%) had diabetes mellitus, and 17 (39%) had atrial fibrillation. Six (27%) discontinued H-ISDN owing to intolerance and poor compliance. There was a trend towards improved 6MWT distance with H-ISDN compared with standard of care at 6 months (mean difference 27 m; 95% CI, −12 to 66), with little differences in secondary efficacy outcomes. Giddiness and hypotension occurred more frequently with H-ISDN, but HF hospitalizations and mortality were less. Conclusions Our pilot study does not support the addition of H-ISDN on top of standard medical therapy to improve exercise capacity in patients with CRS.
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Lim et al. (2020) conducted an RCT in Cardiorenal syndrome (n=44). Hydralazine-isosorbide dinitrate (H-ISDN) vs. Standard of care was evaluated on Mean change in 6-minute walk test (6MWT) distance at 6 months (MD 27, 95% CI -12 to 66). Hydralazine-isosorbide dinitrate did not significantly improve 6-minute walk test distance compared with standard of care at 6 months (mean difference 27 m, 95% CI -12 to 66) in patients with cardiorenal syndrome.
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