Short-term Efficacy of Furosemide, Isosorbide Dinitrate and Their Combination in ADHF

• Status: Suspended
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Treatments: Furosemide; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate

Criteria

Inclusion Criteria:

• Patients aged 18 years or older with increased dyspnoea within the previous 24 hours

• Diagnosed as heart failure by physician

Exclusion Criteria:

• Women with known or suspected pregnancy; myocardial infarction or cardiac surgery within the previous three months;

• Oxygen saturation of less than 85% on room air;

• Respiratory rate greater than 30 breaths/min;

• pH<7.35; systolic blood pressure < 110 bpm;

• Current treatment with oral nitrates in excess of 40 mg daily;

• Current treatment with oral furosemide in excess of 80 mg daily;

• Previous adverse reaction to the study drugs;

• Requirement of noninvasive ventilation;

• Severe renal failure (creatinine >200 µmol/L)