Heart Failure with Reduced Ejection Fraction, Chronic Heart Failure
Conditions
Keywords
Medication Sequencing, Optimization
Brief summary
The SHORT trial compares the current standard optimization protocol to a shortened protocol in a randomized control trial.
Detailed description
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.
Interventions
OTHERStreamlined protocol
A streamlined drug protocol for optimizing heart failure medication
OTHERStandard Protocol
Current standard optimization protocol as per NICE and ESC
Sponsors
Novartis Pharmaceuticals
The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ejection fraction of less than or equal to 40% * Increased NT-proBNP level: * ≥ 600 pg per milliliter or * ≥400 pg per milliliter if they had been hospitalized for heart failure within the previous 12 months or * patients with atrial fibrillation or atrial flutter on baseline electrocardiography were required to have an NT-pro BNP level of at least 900 pg per milliliter, regardless of their history of hospitalization for heart failure or * recent heart failure admission or clinical diagnosis of heart failure. * Patients who are either naïve to or taking no more than 25% target doses of Beta Blockers or ACEi or ARB before starting the trial.
Exclusion criteria
* Systolic BP of less than 100 mmHg on 2 consecutive measurements * Estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73m2 * Type 1 diabetes mellitus * Cognitive impairment that in the opinion of the investigator may lead the patient to be unable to understand and/or comply with the study medications, procedures and/or follow-up * Uncorrected primary valvular disease * Active malignancy treatment at time of visit 1 * Women of child-bearing potential who are not willing to use a medically accepted method of contraception that is reliable in the judgement of the investigator\* * Women who are pregnant or breastfeeding * History of angioedema, or hereditary or idiopathic angioedema * Severe hepatic impairment, biliary cirrhosis or cholestasis * Patients who are receiving treatment with an aliskiren-containing product who have diabetes mellitus or renal impairment (eGFR \<60 ml/min/1.73 m2) * Highly effective methods of contraception include implants, injectables, combined oral contraceptives (the participant must have been on a stable dose for at least 3 months before entering the trial), intrauterine device, vasectomised partner, or true sexual abstinence (when this is the preferred and usual lifestyle of the patient and does not include periodic abstinence \[e.g. calendar, ovulation, symptothermal or post-ovulation methods\]). Use of such methods must be maintained throughout the trial and for 7 days after the end of the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to point of optimization | Maximum follow-up 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of appointments required | Maximum follow-up 6 months | Do patients on the streamlined protocol require fewer appointments to reach the point of optimization? |
| Number of Complications | Maximum follow-up 6 months | Is the streamlined protocol as safe as the current best practice protocol? The number of symptomatic hypotension requiring hospitalization and hyperkalaemia requiring hospitalization. |
| Degree of optimization reached | Maximum follow-up 6 months | 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. |
| Symptomatic change | 6 months | 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. |
| Composite of cardiovascular death and worsening heart failure | 6 months | 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)? |
| Change in NT-pro BNP | 6 months | 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? |
Countries
United Kingdom
Outcome results
None listed