Heart failure & cardiomyopathies
Hydralazine Combined with Conventional Therapy Improved Outcomes in Severe Systolic Dysfunction and Mitral Regurgitation
Primary resultResult — go to the resultHazard ratio 0.613 95% CI 0.427–0.877Authors' conclusion
When administered without inadequate preload, combining early up-titration of hydralazine with EBMs improves outcome in patients with severe systolic dysfunction and significant MR, and it is safe and well tolerated.
Study context
- Population
- Hospitalised patients with decompensated heart failure (HF), left ventricular ejection fraction (LVEF) < 35% and more than moderate mitral regurgitation (MR)
- Participants
- 408 patients
- Comparison
- Hydralazine + conventional treatment vs conventional treatment
- Hydralazine + conventional treatmentn = 205
- Conventional treatmentn = 203reference
- Primary endpoint
- Cardiovascular (CV) death and HF rehospitalisation
- Follow-up
- Mean 3.5 years
Methodological detailsopen-label, 1:1 randomisation, Mean hydralazine dose 191 mg at index admission and 264 mg at study end, EBM prescription rates and dosages did not differ at study end (all P > 0.05)
- Open-label
- 1:1 randomisation
- Mean hydralazine dose 191 mg at index admission and 264 mg at study end
- EBM prescription rates and dosages did not differ at study end (all P > 0.05)
Primary result
As reported in the abstract
Hazard ratio
0.613
95% CI 0.427–0.877
P < 0.001
Events by treatment group
Hydralazine + conventional treatmentvs Conventional treatment
HR 0.613 (95% CI 0.427–0.877); P < 0.001
Further findings
In-hospital death during index admission
P = 0.001
Safety
- Side effects did not differ between the two groups
Original publication
Hydralazine Combined with Conventional Therapy Improved Outcomes in Severe Systolic Dysfunction and Mitral Regurgitation. ESC Heart Fail. Published 27 October 2023. doi:10.
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