Efficacy of a Streamlined Heart Failure Optimization Protocol (NCT05021419) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of a Streamlined Heart Failure Optimization Protocol
United Kingdom60 participantsStarted 2022-07-17
Plain-language summary
The SHORT trial compares the current standard optimization protocol to a shortened protocol in a randomized control trial.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 w…
What they're measuring
1
Time to point of optimization
Timeframe: Maximum follow-up 6 months
Trial details
NCT IDNCT05021419
SponsorThe Queen Elizabeth Hospital King's Lynn NHS Foundation Trust