Short-term Efficacy of Furosemide, Isosorbide Dinitrate and Their Combination in ADHF
Status:
Suspended
Trial end date:
2020-06-01
Target enrollment:
Participant gender:
Summary
Background:
Acute decompensated heart failure (ADHF) is a common and potentially fatal cause of acute
respiratory distress that requires immediate treatment in emergency department. The mortality
rates are as high as 20% after discharge. Currently, furosemide is the most commonly used
medicine in emergency department for ADHF. Although nitrate was proved to generate similar
effect when compared to furosemide, less than 30% of patients received nitrates. This
practice happens not only in Hong Kong, but also all around the world. Moreover, there is
limited evidence to support a difference in ADHF patients receiving intravenous nitrate
vasodilator therapy or alternative interventions.
The aims of the study are:
1. To monitor the changes in concentration of cardiac biomarkers, VAS dyspnoea score and
cardiac output before and after treatment of furosemide, isosorbide dinitrate or both.
2. To investigate whether the changes in concentration of cardiac biomarkers, VAS dyspnoea
score and cardiac output before and after treatment is associated with the change in
length of hospital stay.
3. To investigate whether combination treatment with intravenous furosemide and isosorbide
dinitrate in patients with HF reduces VAS dyspnoea score, in-hospital mortality, length
of hospital stay and number of readmission to a higher extend than do either medication
alone.
4. To evaluate the prognostic values of novel cardiac biomarkers on 7-day, 14-day, 30-day
and 6-month mortality and readmission.
Design:
This single-blinded randomized controlled study will be conducted in the Prince of Wales
Hospital in Hong Kong.
Setting and Subjects:
Patients with dyspnoea will be screened and recruited from adult patients attending the
emergency department at the Prince of Wales Hospital.
Interventions:
Patients with acute decompensated heart failure will be randomly treated with intravenous
furosemide, isosorbide dinitrate or both. Level of dyspnoea, multi-biomarker and haemodynamic
parameters will be measured before and after treatment.
Outcomes:
The primary outcome is the change in VAS dyspnoea score after treatment of furosemide,
isosorbide dinitrate or both. The secondary outcomes are the changes in concentration of
biomarkers and cardiac output, the number of in-hospital mortality, length of hospital stay,
7-day and 30-day and 6-month mortality and readmission.