Skip to main content
OpenTrials
Completed

NCT Number: NCT05021419

Efficacy of a Streamlined Heart Failure Optimization Protocol

The SHORT trial compares the current standard optimization protocol to a shortened protocol in a randomized control trial.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Elizabeth Hospital King's Lynn

Kings Lynn, Norfolk, PE30 4ET, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Streamlined protocol

Other

A streamlined drug protocol for optimizing heart failure medication

Standard protocol

Other

Current standard optimization protocol as per NICE and ESC

Primary outcomes

  1. Time to point of optimization

    Time frame: 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 outcomes

  1. Degree of optimization reached

    Time frame: Maximum follow-up 6 months

    • 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.

  2. Number of appointments required

    Time frame: Maximum follow-up 6 months

    Do patients on the streamlined protocol require fewer appointments to reach the point of optimization?

  3. Number of Complications

    Time frame: 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.

  4. Change in NT-pro BNP

    Time frame: 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?

  5. Symptomatic change

    Time frame: 6 months

    • 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.

  6. Composite of cardiovascular death and worsening heart failure

    Time frame: 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)?

Sponsors and collaborators

Lead sponsor

The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust

Other

Collaborators

  • Novartis Pharmaceuticals

Registry information

Official study title

Efficacy of a Streamlined Heart Failure Optimisation PRoTocol for Patients with Severely Impaired Left Ventricular Systolic Function, a Randomised Controlled Trial (SHORT Trial)

Acronym: SHORT

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 25, 2021
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.