search
Back to results

Efficacy of a Streamlined Heart Failure Optimization Protocol (SHORT)

Primary Purpose

Heart Failure With Reduced Ejection Fraction, Chronic Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Streamlined protocol
Standard Protocol
Sponsored by
The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Reduced Ejection Fraction focused on measuring Medication Sequencing, Optimization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

-

Sites / Locations

  • Queen Elizabeth Hospital King's Lynn

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Arm

Streamlined protocol arm

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Number of appointments required
Do patients on the streamlined protocol require fewer appointments to reach the point of optimization?
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.
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?
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.
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)?

Full Information

First Posted
August 19, 2021
Last Updated
August 19, 2021
Sponsor
The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust
Collaborators
Novartis Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT05021419
Brief Title
Efficacy of a Streamlined Heart Failure Optimization Protocol
Acronym
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).
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2021 (Anticipated)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust
Collaborators
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Reduced Ejection Fraction, Chronic Heart Failure
Keywords
Medication Sequencing, Optimization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Arm
Arm Type
Active Comparator
Arm Description
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
Arm Title
Streamlined protocol arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Streamlined protocol
Intervention Description
A streamlined drug protocol for optimizing heart failure medication
Intervention Type
Other
Intervention Name(s)
Standard Protocol
Intervention Description
Current standard optimization protocol as per NICE and ESC
Primary Outcome Measure Information:
Title
Time to point of optimization
Description
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.
Time Frame
Maximum follow-up 6 months
Secondary Outcome Measure Information:
Title
Degree of optimization reached
Description
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
Time Frame
Maximum follow-up 6 months
Title
Number of appointments required
Description
Do patients on the streamlined protocol require fewer appointments to reach the point of optimization?
Time Frame
Maximum follow-up 6 months
Title
Number of Complications
Description
Is the streamlined protocol as safe as the current best practice protocol? Number of symptomatic hypotension requiring hospitalization and Hyperkalaemia requiring hospitalization.
Time Frame
Maximum follow-up 6 months
Title
Change in NT-pro BNP
Description
Do patients on the streamlined protocol have greater decrease in NT-pro BNP levels at 6 months after initial optimization appointment?
Time Frame
6 months
Title
Symptomatic change
Description
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.
Time Frame
6 months
Title
Composite of cardiovascular death and worsening heart failure
Description
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)?
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ejection fraction of less than 35% 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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rudolf M Duehmke, BSc MBBS PhD
Phone
+441553613613
Email
rudolf.duehmke@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rudolf M Duehmke, BSc MBBS PhD
Organizational Affiliation
The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth Hospital King's Lynn
City
King's Lynn
State/Province
Norfolk
ZIP/Postal Code
PE30 4ET
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of a Streamlined Heart Failure Optimization Protocol

We'll reach out to this number within 24 hrs