Efficacy of a Streamlined Heart Failure Optimization Protocol

Chronic Heart Failure Clinical Trial

— SHORT  

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).

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05021419
• Other study ID #: Qehkl
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2021
• Est. completion date: February 2023

Study information

• Verified date: July 2021
• Source: The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust
• Contact: Rudolf M Duehmke, BSc MBBS PhD
• Phone: +441553613613
• Email: rudolf.duehmke[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 2023
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Ejection fraction of less than 35%

2. Increased NT-pro BNP levels > 600 pg per milliliter or =400 pg per milliliter if they had been hospitalized for heart failure within the previous 12 months. Patients with atrial fibrillation or atrial flutter on baseline electrocardiography were required to have an NT-proBNP level of at least 900 pg per milliliter, regardless of their history of hospitalization for heart failure.

Exclusion Criteria:

1. Systolic BP of less than 100 mmHg on 2 consecutive measurements 2. eGFR less than 30 ml/min/1.73m2 3. Type 1 diabetes mellitus 4. 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 5. Uncorrected primary valvular disease 6. Active malignancy treatment at time of visit 1 7. 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 8. Women who are pregnant or breastfeeding -

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Other:
• Streamlined protocol
A streamlined drug protocol for optimizing heart failure medication
• Standard Protocol
Current standard optimization protocol as per NICE and ESC

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth Hospital King's Lynn	King's Lynn	Norfolk

Sponsors (2)

Lead Sponsor	Collaborator
The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust	Novartis Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to point of optimization	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, blood pressure, or raised serum potassium or serum Creatinine.	Maximum follow-up 6 months
Secondary	Degree of optimization reached	1. Do patients on the streamlined protocol reach a greater "degree of optimization" **?; ** degree of optimization defined as the average percentage of the target doses reached across the four heart failure medication drug groups at the point of optimization	Maximum follow-up 6 months
Secondary	Number of appointments required	Do patients on the streamlined protocol require fewer appointments to reach the point of optimization?	Maximum follow-up 6 months
Secondary	Number of Complications	Is the streamlined protocol as safe as the current best practice protocol? Number of symptomatic hypotension requiring hospitalization and Hyperkalaemia requiring hospitalization.	Maximum follow-up 6 months
Secondary	Change in NT-pro BNP	Do patients on the streamlined protocol have greater decrease in NT-pro BNP levels at 6 months after initial optimization appointment?	6 months
Secondary	Symptomatic change	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.	6 months
Secondary	Composite of cardiovascular death and worsening heart failure	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)?	6 months