Clinical trial NCT05021419: Efficacy of a Streamlined Heart Failure Optimization Protocol
Official title: Efficacy of a Streamlined Heart Failure Optimisation PRoTocol for Patients with Severely Impaired Left Ventricular Systolic Function, a Randomised Controlled Trial (SHORT Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure with Reduced Ejection Fraction
Chronic Heart Failure
Keywords: Medication Sequencing
Optimization
Lead sponsor: The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2021-08-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to point of optimization
timeFrame: Maximum follow-up 6 months
Secondary outcomes:
measure: Degree of optimization reached
timeFrame: Maximum follow-up 6 months
measure: Number of appointments required
timeFrame: Maximum follow-up 6 months
measure: Number of Complications
timeFrame: Maximum follow-up 6 months
measure: Change in NT-pro BNP
timeFrame: 6 months
measure: Symptomatic change
timeFrame: 6 months
measure: Composite of cardiovascular death and worsening heart failure
timeFrame: 6 months
Other outcomes:
Locations:
city: King's Lynn
country: United Kingdom
facility: Queen Elizabeth Hospital King's Lynn
state: Norfolk
Study officials:
affiliation: The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust
name: Rudolf M Duehmke, BSc MBBS PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: National Guideline Centre (UK). Chronic Heart Failure in Adults: Diagnosis and Management. London: National Institute for Health and Care Excellence (NICE); 2018 Sep. Available from http://www.ncbi.nlm.nih.gov/books/NBK536075/
citation: Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.
citation: McMurray JJV, Solomon SD, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Belohlavek J, Bohm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukat A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Petrie MC, Vinh PN, Schou M, Tereshchenko S, Verma S, Held C, DeMets DL, Docherty KF, Jhund PS, Bengtsson O, Sjostrand M, Langkilde AM; DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008. doi: 10.1056/NEJMoa1911303. Epub 2019 Sep 19.
citation: McMurray JJV, Packer M. How Should We Sequence the Treatments for Heart Failure and a Reduced Ejection Fraction?: A Redefinition of Evidence-Based Medicine. Circulation. 2021 Mar 2;143(9):875-877. doi: 10.1161/CIRCULATIONAHA.120.052926. Epub 2020 Dec 30. No abstract available.