Targeted Assessment in High-Risk paTients With dIAbetes to ideNtify Undiagnosed Heart Failure

NCT05705869 | Active Not Recruiting

• 1 other identifier: GN22CA228
• Study Type: interventional
• Target: 706
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Heart Failure; Diabetes Mellitus; Type 1 Diabetes; Type 2 Diabetes; Cardiovascular Diseases

Keywords

Screening; Primary Care; Secondary Care; NT-proBNP; Echocardiogram; Diagnostic Pathway

Outcome Measures

Primary Outcomes (1)

• Diagnosis of heart failure within 6 months

  6 months

Secondary Outcomes (2)

• Diagnosis of HFrEF within 6 months

  6 months

• People diagnosed with HFrEF receiving GDMT within 6 months

  6 months

Other Outcomes (16)

• 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

Study Arms (2)

Routine care arm

NO INTERVENTION

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.

Investigational arm

EXPERIMENTAL

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

Interventions

NT-proBNP DIAGNOSTIC_TEST

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.

Investigational arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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 \[\>50% left main or \>70% left anterior descending, circumflex or right coronary artery\])
• Persistent or permanent atrial fibrillation (not paroxysmal atrial fibrillation)
• Previous ischemic or embolic stroke
• Peripheral arterial disease (previous surgical or percutaneous revascularisation or a documented stenosis greater than 50% of a major peripheral arterial vessel).
• 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).
• Regular loop diuretic use (any dose at any dosing interval) for \>30 days.
• 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).

You may not qualify if:

• Inability to give informed consent e.g., due to significant cognitive impairment.
• Previous documented diagnosis of heart failure.
• Echocardiogram or NT-proBNP interpreted as excluding heart failure within 12 months.
• 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

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• AstraZeneca: collaborator

Study Sites (2)

Glasgow Royal Infirmary

Glasgow, Scotland, G4 0SF, United Kingdom

Location

Queen Elizabeth University Hospital

Glasgow, Scotland, G51 4TF, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure; Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Mark C Petrie, MbChB

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 31, 2023
• Study Start: December 22, 2022
• Primary Completion: November 30, 2025
• Study Completion (Estimated): December 1, 2032
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)