The Prognostic Impact of Using High-dose Hydralazine in Severe Systolic Heart Failure With Hemodynamically Significant Mitral Regurgitation

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Background: Severe systolic heart failure would be complicated with low cardiac output and high left ventricular filling pressure and the clinical presentations would be low blood pressure, poor peripheral perfusion, and pulmonary edema. Severe systolic heart failure with hemodynamically significant mitral regurgitation brings even more challenged since the obvious elevation of left atrial pressure induces more pulmonary congestion and backward flow of regurgitation in cases with already low cardiac output and poor peripheral perfusion complicates more severe of low cardiac output. Surgical interventions in those cases aren't strongly recommended due to very high operation risk. In the era of lack of nitroprusside in Taiwan (more than 7 years), hydralazine, a direct vasodilator, is a potential substitute for treatment of those cases. The advantages of hydralazine include 1) different dosage forms are available (10 mg, 25 mg, and 50 mg); 2) short half-life makes it reaching steady blood concentration in short period and allow to up- titrate rapidly and also recover fast while adverse reaction occurs; 3) it is much cheaper than other evidence-based medications. In this study, the investigators try to use rapid up-titration of hydralazine to maximal tolerable dose, almost up to 300-400 mg per day, combined with other evidence-based medications in cases with left ventricular ejection fraction less than 35% and mitral regurgitation severity more than moderate degree and assess the prognostic impact.

Objective: Four hundred of patients with severe systolic dysfunction and hemodynamically significant mitral regurgitation, who were admitted for intensive care unit for acute decompensated heart failure, will be enrolled and the participants will be divided into two groups according 1 to 1 randomization process. Control group will receive conventional treatment with tolerable maximal dose of evidence-based medications and study group will use hydralazine with rapid up-titration, if no clinical adverse responses were noted, following by or simultaneously using evidence-based medications. The end-points include in- hospital mortality, 3-year all-cause mortality and heart failure rehospitalization.

During follow-up period, any adverse response of high-dose hydralazine including lupus-like syndrome and arthritis will be monitored.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaohsiung Veterans General Hospital.
• Collaborator: E-DA Hospital
• Treatments: Hydralazine

Criteria

Inclusion Criteria:

• aged 18 years or older

• acute decompensated heart failure due to severe left ventricular systolic dysfunction combined with hemodynamically significant mitral regurgitation. Severe systolic dysfunction and hemodynamically significant mitral regurgitation are defined as left ventricular ejection fraction less than 35% and mitral regurgitant volume more than 45 ml (more than moderate degree), respectively

Exclusion Criteria:

• cancer or other significant co-morbid diseases with expected life span less than 3 years

• adverse effects of hydralazine

• surgical interventions of mitral regurgitation will be done in follow-up period which change the course of native condition

• other valvular conditions other than mitral regurgitation with severity more than or equal to moderate degree, particularly mitral stenosis, and aortic regurgitation/stenosis

• lack of written informed consent.