Efficacy of a Streamlined Heart Failure Optimization Protocol
- Conditions
- Heart Failure with Reduced Ejection FractionChronic Heart Failure
- Interventions
- Other: Standard ProtocolOther: Streamlined protocol
- Registration Number
- NCT05021419
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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.
-
Systolic BP of less than 100 mmHg on 2 consecutive measurements
-
Estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73m2
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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
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Uncorrected primary valvular disease
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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*
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Women who are pregnant or breastfeeding
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History of angioedema, or hereditary or idiopathic angioedema
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Severe hepatic impairment, biliary cirrhosis or cholestasis
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Arm Standard Protocol Active Comparator: Standard Arm Both the current the European society of cardiology guidelines and National Institute of Health and Care Excellence currently advise that chronic stable heart failure patients with severely impaired left ventricular systolic function should initially be optimized as follows: Visit 1: ACEi/ARB and Low Betablocker commenced Visit 2: ACEi/ARB up-titrated; (Beta Blocker up-titrated) Visit 3: ACEi/ARB up-titrated; (Beta Blocker up-titrated) Visit 4: Switch ACEi/ARB to Entresto 100mg Visit 5: Modify Entresto dose to 200mg Visit 6: MRA Added Visit 7: MRA up-titrated Visit 8: SGLT2i started Streamlined protocol arm Streamlined protocol Patients are optimized according to the accelerated protocol adapted from and based on the principles proposed by Prof McMurray and Prof Packer (Circulation 2021;143:875-877) Visit 1: Low Dose Beta Blocker started, SGLT2i started + Entresto 100 mg bd started Visit 2: MRA Added if renal function and potassium levels permit (Betablocker increased if BP and pulse rate permit) Visit 3: MRA up-titrated if BP and renal function and potassium levels permit (Betablocker increased if BP and pulse rate permit) Visit 4+: Betablocker increased if BP and pulse rate permit. Further visits may be required to facilitate a gentle up-titration of betablockers.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.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.
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?
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)?
Trial Locations
- Locations (1)
Queen Elizabeth Hospital King's Lynn
🇬🇧King's Lynn, Norfolk, United Kingdom