The SHORT trial compares the current standard optimization protocol to a shortened protocol in a randomized control trial.
The SHORT trial compares the current standard optimization protocol to a shortened protocol in a randomized control trial. It assesses whether an accelerated protocol leads to faster optimization and a greater degree of optimization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
A streamlined drug protocol for optimizing heart failure medication
Current standard optimization protocol as per NICE and ESC
Queen Elizabeth Hospital King's Lynn
Kings Lynn, Norfolk, United Kingdom
Time to point of optimization
Do patients on the streamlined protocol reach the point of optimization\* earlier? \*point of optimization is defined as the point in time at which no medication could be increased further either due to achievement of target doses or limited by symptoms, low heart rate, BP, or raised serum potassium or serum Creatinine.
Time frame: Maximum follow-up 6 months
Degree of optimization reached
1\. Do patients on the streamlined protocol reach a greater "degree of optimization" \*\*? \*\*degree of optimization is defined as the average percentage of the target doses reached across the four heart failure drug groups at the point of optimization.
Time frame: Maximum follow-up 6 months
Number of appointments required
Do patients on the streamlined protocol require fewer appointments to reach the point of optimization?
Time frame: Maximum follow-up 6 months
Number of Complications
Is the streamlined protocol as safe as the current best practice protocol? The number of symptomatic hypotension requiring hospitalization and hyperkalaemia requiring hospitalization.
Time frame: Maximum follow-up 6 months
Change in NT-pro BNP
Do patients on the streamlined protocol have a greater decrease in N-terminal pro-B-type natriuretic peptide (NT-pro BNP) levels 6 months after the initial optimization appointment?
Time frame: 6 months
Symptomatic change
5\. Do patients on the streamlined protocol have a greater reduction in symptoms at 6 months after the initial optimization appointment? Use of the Kansas City Cardiomyopathy Questionaire score\*\*\*. \*\*\*Kansas City Cardiomyopathy Questionaire score assesses health status of patients with heart failure via four domains: Physical Limitation, Symptom Frequency, Quality of Life and Social Limitations. Each domain provides an individual score from 0 to 100, with 0 denoting the worst and 100 the best possible health status.
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Time frame: 6 months
Composite of cardiovascular death and worsening heart failure
Do patients on the streamlined protocol have a lower incidence of the composite endpoint of cardiovascular death and worsening heart failure (defined as hospitalization or an urgent visit resulting in intravenous therapy for heart failure)?
Time frame: 6 months