Targeted Assessment in High-Risk paTients With dIAbetes to ideNtify Undiagnosed Heart Failure (TARTAN-HF)

Targeted Assessment in High-Risk paTients With dIAbetes to ideNtify Undiagnosed Heart Failure (TARTAN-HF)

This is a prospective, multicentre, unblinded, randomised, controlled trial. The primary aim is to assess a targeted screening strategy to detect undiagnosed heart failure in high-risk patients with diabetes.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Heart Failure; Diabetes Mellitus; Type 1 Diabetes; Type 2 Diabetes
• Intervention / Treatment: Diagnostic test: NT-proBNP

Detailed Description

This is a prospective, multicentre, unblinded, randomised, controlled trial. The primary aim is to assess a targeted screening strategy to detect undiagnosed heart failure in high-risk patients with diabetes.

Participants will be recruited from the diabetes service in two NHS health boards in Scotland; NHS Greater Glasgow and Clyde and NHS Lanarkshire. At the point of recruitment and consent, patients will be randomised to one of two arms:

1. "Routine care arm" - patients in this arm will undergo routine diabetes care. They will be managed and followed up as per routine clinical care. They will be remotely monitored for HF events electronically. Quality of life questionnaires (Kansas City Cardiomyopathy Questionnaire-12 and EQ-5D) will be completed electronically through CASTOR program in this arm (with the option of paper versions for participants who can not use CASTOR).

   OR

2. "Investigational arm" - patients in this arm will have a blood sample taken to measure N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) using a Roche assay. In addition to this, blood samples for haemoglobin, creatinine, HbA1c, cholesterol profile, liver function tests and eGFR will be collected. Quality of life questionnaires (Kansas City Cardiomyopathy Questionnaire-12 and EQ-5D) will be completed electronically through CASTOR program in this arm (with the option of paper versions for participants who can not use CASTOR).

All patients in this arm will also have an ECG and basic body measurements and observations measured. Further venous blood samples will be collected and stored within Glasgow University storage facilities for future measurement of relevant biomarkers and for use in future ethically approved research. Urine samples will also be collected for measurement of urine albumin:creatinine ratio and for future measurement of relevant biomarkers and use in future ethically approved research.

Patients with an elevated Roche NT-proBNP (≥125 pg/mL) will undergo a full cart-based transthoracic echocardiogram along with a clinical examination for signs of HF and a HF symptom assessment. A British Society of Echocardiography minimum dataset will be obtained, and report created.

Patients will then also undergo a handheld echocardiogram with a CE-marked handheld point of care (POC) EchoNous Kosmos echocardiogram device. The handheld echocardiogram images will be acquired by a British Society of Echocardiography accredited operator. The US2.ai algorithm (which is also CE marked) will generate an AI-automated echocardiogram report.

Patients who are classified as having heart failure (HFrEF, HFmrEF, or HFpEF) will be managed according to the latest version of European Society of Cardiology guidelines for the diagnosis and treatment of acute and chronic heart failure. The results of the cart-based echocardiogram will be used during the determination of the presence or absence of HF.

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kieran F Docherty, MbChB; Phone Number: 0141 330 2677; Email: kieran.docherty@glasgow.ac.uk
• Study Contact Backup: Name: Mark C Petrie, MbChB; Phone Number: 0141 330 2677; Email: mark.petrie@glasgow.ac.uk

Study Locations

• United Kingdom
  • Scotland
    • Glasgow, Scotland, United Kingdom, G4 0SF
      • Recruiting
      • Glasgow Royal Infirmary
      • Contact: Kieran F Docherty, MbChB; Phone Number: 0141 330 2677; Email: kieran.docherty@glasgow.ac.uk
      • Contact: Daniel R Taylor-Sweet, MbChB; Phone Number: 141 330 2677; Email: daniel.taylor-sweet@ggc.scot.nhs.uk
      • Principal Investigator: Kieran F Docherty
      • Sub-Investigator: Mark C Petrie
      • Sub-Investigator: Ross Campbell
      • Sub-Investigator: Daniel R Taylor-Sweet
      • Sub-Investigator: John JV McMurray
      • Sub-Investigator: Shona Jenkins
      • Sub-Investigator: Brian Kennon
      • Sub-Investigator: Gerald McKay
      • Sub-Investigator: Robin Weir
      • Sub-Investigator: Colin Petrie
    • Glasgow, Scotland, United Kingdom, G51 4TF
      • Recruiting
      • Queen Elizabeth University Hospital
      • Contact: Kieran F Docherty, MbChB; Phone Number: 0141 330 2677; Email: kieran.docherty@glasgow.ac.uk
      • Principal Investigator: Kieran F Docherty
      • Sub-Investigator: Mark C Petrie
      • Sub-Investigator: Ross Campbell
      • Sub-Investigator: Daniel R Taylor-Sweet
      • Sub-Investigator: John JV McMurray
      • Sub-Investigator: Shona Jenkins
      • Sub-Investigator: Brian Kennon
      • Sub-Investigator: Gerald McKay
      • Sub-Investigator: Robin Weir
      • Sub-Investigator: Colin Petrie
      • Contact: Daniel R Taylor-Sweet, MbChB; Phone Number: 0141 330 2677; Email: daniel.taylor-sweet@glasgow.ac.uk
      • Sub-Investigator: Katriona Brooksbank

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female ≥40 years of age
• Informed consent
• An established diagnosis of diabetes (type 1 or type 2)

• At least one additional risk factor for heart failure:

  1. Coronary artery disease (either a previous documented type 1 myocardial infarction or coronary artery bypass grafting or percutaneous coronary intervention or documented stenosis of an epicardial coronary artery [50% left main or >70% left anterior descending, circumflex or right coronary artery])
  2. Persistent or permanent atrial fibrillation (not paroxysmal atrial fibrillation)
  3. Previous ischemic or embolic stroke
  4. Peripheral arterial disease (previous surgical or percutaneous revascularisation or a documented stenosis greater than 50% of a major peripheral arterial vessel).
  5. Chronic kidney disease (defined as an estimated glomerular filtration rate <60mL/min/1.73m2 or eGFR 60-90mL/min/1.73m2 and UACR >300mg/g).
  6. Regular loop diuretic use (any dose at any dosing interval) for >30 days.
  7. COPD (evidenced by one of the following; PFTs showing airway obstruction, diagnosis by respiratory physician, CT scan reporting presence of emphysema or treatment with national guideline-advocated COPD therapy).

Exclusion criteria:

• Inability to give informed consent e.g., due to significant cognitive impairment.
• Previous documented diagnosis of heart failure.
• Currently receiving scheduled renal replacement therapy.
• Anyone who, in the investigators' opinion, is not suitable to participate in the trial for other reasons e.g., a diagnosis which may compromise survival over the study period

Exclusion Criteria:

• Inability to give informed consent e.g., due to significant cognitive impairment.
• Previous documented diagnosis of heart failure.
• Currently receiving scheduled renal replacement therapy.
• Anyone who, in the investigators' opinion, is not suitable to participate in the trial for other reasons e.g., a diagnosis which may compromise survival over the study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Routine care arm; Patients in this arm will undergo routine diabetes care. They will be managed and followed up as per routine clinical care. They will be remotely monitored for heart failure events electronically. Quality of life questionnaires (Kansas City Cardiomyopathy Questionnaire-12 and EQ-5D) will be collected.
EXPERIMENTAL: Investigational arm; Patients in this arm will have a blood sample taken to measure N-terminal prohormone of B-type natriuretic peptide (NT-proBNP). In addition to this, routine blood samples, an ECG, body measurements, patient reported outcomes and observations will be recorded. Further blood and urine samples will be collected and stored within Glasgow University storage facilities for future measurement of relevant biomarkers and for use in future ethically approved research. Patients with an elevated NT-proBNP (≥125 pg/mL) will undergo a full cart-based transthoracic echocardiogram along with a clinical examination for signs of HF and a HF symptom assessment. Patients will then also undergo a handheld echocardiogram with a CE-marked handheld point of care EchoNous Kosmos echocardiogram device. Patients who are classified as having heart failure (HFrEF, HFmrEF, or HFpEF) will be managed according to the latest version of European Society of Cardiology guidelines.	Diagnostic test: NT-proBNP; NT-proBNP will be measured in all participants in the Investigational arm. If the level of the NT-proBNP is elevated (≥125pg/mL) participants will undergo a full cart-based transthoracic echocardiogram along with a clinical examination for signs of HF and a HF symptom assessment. Participants with HF identified will be referred to their local HF clinic for ongoing management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diagnosis of heart failure within 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Diagnosis of HFrEF within 6 months	6 months
People diagnosed with HFrEF receiving GDMT within 6 months	6 months

Other Outcome Measures

Outcome Measure	Time Frame
All-cause mortality at 1 year	1 year
Diagnosis of HFmrEF within 6 months	6 months
Diagnosis of HFpEF within 6 months	6 months
People diagnosed with HFmrEF and HFpEF receiving SGLT2i therapy within 6 months	6 months
Diagnosis of asymptomatic left ventricular dysfunction (LVEF≤40%) within 6 months	6 months
Time to first heart failure hospitalisation at 1 year	1 year
Time to first heart failure hospitalisation at 2 years	2 years
Time to first heart failure hospitalisation at 5 years	5 years
All-cause mortality at 2 years	2 years
All-cause mortality at 5 years	5 years
Time to first occurence of any components of the following clinical composite 1) heart failure hospitalisation 2) all-cause mortality at 1 year	1 year
Time to first occurence of any components of the following clinical composite 1) heart failure hospitalisation 2) all-cause mortality at 2 years	2 years
Time to first occurence of any components of the following clinical composite 1) heart failure hospitalisation 2) all-cause mortality at 5 years	5 years
The incremental cost-effectiveness ratio (ICER) will be expressed as incremental costs/life-year gained	5 years
he accuracy of handheld echocardiography with AI-automated reporting compared to full cart-based echocardiogram and manual reporting for the measurement of LVEF (%)	6 months
The number of patients in the NT-proBNP/echocardiography group with echocardiographic features of potential amyloid as assessed by the US2.ai algorithm report conclusion of "amyloid to be considered"	6 months

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Mark C Petrie, MbChB, University of Glasgow

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 22, 2022
• Primary Completion (ANTICIPATED): June 1, 2024
• Study Completion (ANTICIPATED): December 1, 2032

Study Registration Dates

• First Submitted: December 21, 2022
• First Submitted That Met QC Criteria: January 27, 2023
• First Posted (ACTUAL): January 31, 2023

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2023
• Last Update Submitted That Met QC Criteria: January 27, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Primary Care; Screening; Echocardiogram; NT-proBNP; Secondary Care; Diagnostic Pathway
• Additional Relevant MeSH Terms: Heart Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Heart Failure; Cardiovascular Diseases; Diabetes Mellitus
• Other Study ID Numbers: GN22CA228

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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