NCT04217135

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

Status unknown Phase 4 Last updated 6 January 2022

What this trial tests

Phase 4 trial testing evidence-based medications vs. high-dose hydralazine + evidence-based medications in Systolic Heart Failure Stage D (Disorder) in 400 participants. Status unknown.

Timeline

1 January 2017

Primary endpoint
31 July 2022

31 July 2022

Quick facts

Lead sponsor	Kaohsiung Veterans General Hospital.
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	400
Start date	1 January 2017
Primary completion	31 July 2022
Estimated completion	31 July 2022
Sites	1 location across Taiwan

Drugs / interventions tested

• evidence-based medications vs. high-dose hydralazine + evidence-based medications — full drug profile →

Conditions studied

• Systolic Heart Failure Stage D (Disorder) — all drugs for Systolic Heart Failure Stage D (Disorder) →
• Mitral Regurgitation — all drugs for Mitral Regurgitation →

Sponsor

Kaohsiung Veterans General Hospital.

Who can join

18 and older, any sex, with Systolic Heart Failure Stage D (Disorder) or Mitral Regurgitation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Hydralazine combined with conventional therapy improved outcomes in severe systolic dysfunction and mitral regurgitation.
   Hsiao SH, Hsiao CS, Shiau JW, Chiou KR. · · 2024 · cited 2× · PMID 37897153 · DOI 10.1002/ehf2.14564