Dataset Information

Nitrates in combination with hydralazine in cardiorenal syndrome: a randomized controlled proof-of-concept study.

ABSTRACT:

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.

SUBMITTER: Lim SL

PROVIDER: S-EPMC7754984 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Publications

Nitrates in combination with hydralazine in cardiorenal syndrome: a randomized controlled proof-of-concept study.

Lim Shir Lynn SL Gandhi Mihir M Woo Kai Lee KL Chua Horng Ruey HR Lim Yoke Ching YC Sim David K L DKL Lee Sheldon S G SSG Teoh Yee Leong YL Richards Arthur Mark AM Lam Carolyn S P CSP

ESC heart failure 20201104 6

<h4>Aims</h4>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.<h4>Methods and results</h4>This multi-centre, single-blind, randomized trial in Singapore enrolled CRS patients, defined as chronic ...[more]

PMID: 33150715

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Dataset Information

Nitrates in combination with hydralazine in cardiorenal syndrome: a randomized controlled proof-of-concept study.

Aims

Methods and results

Conclusions

Publications

Nitrates in combination with hydralazine in cardiorenal syndrome: a randomized controlled proof-of-concept study.

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