Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05021419
Other study ID # Qehkl
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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 -

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03597646 - The Effect of Kinesio Taping on Pulmonary Function and Functional Capacity in Patients With Chronic Heart Failure N/A
Terminated NCT04065997 - Apogee International
Withdrawn NCT03675113 - Effect of Upper Extremity Aerobic Exercise Training on Exercise Capacity Patients With Chronic Heart Failure N/A
Completed NCT02916160 - Sacubitril-valsartan and Heart Failure Patients : the ENTRESTO-SAS Study Phase 4
Completed NCT03126656 - Effects of Testosterone on Myocardial Repolarization Phase 4
Completed NCT02247245 - The Influence of Heart Rate Limitation on Exercise Tolerance in Pacemaker Patients. N/A
Completed NCT02268500 - VAccination to Improve Clinical outComes in Heart Failure Trial: a Feasibility Study (VACC-HeFT) Phase 4
Completed NCT01919918 - Muscle Afferent Feedback Effects in Patients With Heart Failure Phase 1
Terminated NCT01906957 - Cognition and Exercise Training N/A
Not yet recruiting NCT01669395 - Severe Heart Failure and Homebased Rehabilitation - An Intersectoral Randomized Controlled Trial N/A
Completed NCT00984529 - Evaluation of Clinical Signs and Symptoms of Chronic Heart Failure in Patients Treated With Candesartan Cilexetil in Croatia N/A
Recruiting NCT00863421 - Sleep Disordered Breathing in Patients With Chronic Heart Failure N/A
Completed NCT02840565 - Tolerability, Pharmacokinetics and Pharmacodynamics of Six Multiple Rising Dose Regimens of BIA 5-453 Phase 1
Completed NCT02441218 - Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre Study Phase 3
Completed NCT00149409 - Omega-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Severe Chronic Heart Failure Phase 2/Phase 3
Terminated NCT05532046 - A Study to Learn How Safe Study Drug BAY2413555 is, How it Affects the Body, and How it Moves Into, Through, and Out of the Body Over 4 Weeks of Use in Participants With Heart Failure and Implanted Cardiac Defibrillator or Cardiac Resynchronization Devices (ICD/CRT) Phase 1
Recruiting NCT04984928 - Readmission Risk of Patients With Heart Failure.
Completed NCT02814097 - A Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction Phase 2
Active, not recruiting NCT05560737 - ODYSSEE-vCHAT Mental Health Program for Heart Failure and Kidney Disease Patients
Recruiting NCT03286127 - Palliative Outcome Evaluation Muenster I