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

Heart Failure Clinical Trial

— TARTAN-HF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05705869
• Other study ID #: GN22CA228
• Status: Recruiting
• Phase: N/A
• Start date: December 22, 2022
• Est. completion date: December 2032

Study information

• Verified date: January 2023
• Source: NHS Greater Glasgow and Clyde
• Contact: Kieran F Docherty, MbChB
• Phone: 0141 330 2677
• Email: kieran.docherty[@]glasgow.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2032
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Glasgow Royal Infirmary	Glasgow	Scotland
United Kingdom	Queen Elizabeth University Hospital	Glasgow	Scotland

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diagnosis of HFmrEF within 6 months		6 months
Other	Diagnosis of HFpEF within 6 months		6 months
Other	People diagnosed with HFmrEF and HFpEF receiving SGLT2i therapy within 6 months		6 months
Other	Diagnosis of asymptomatic left ventricular dysfunction (LVEF=40%) within 6 months		6 months
Other	Time to first heart failure hospitalisation at 1 year		1 year
Other	Time to first heart failure hospitalisation at 2 years		2 years
Other	Time to first heart failure hospitalisation at 5 years		5 years
Other	All-cause mortality at 1 year		1 year
Other	All-cause mortality at 2 years		2 years
Other	All-cause mortality at 5 years		5 years
Other	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
Other	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
Other	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
Other	The incremental cost-effectiveness ratio (ICER) will be expressed as incremental costs/life-year gained		5 years
Other	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
Other	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
Primary	Diagnosis of heart failure within 6 months		6 months
Secondary	Diagnosis of HFrEF within 6 months		6 months
Secondary	People diagnosed with HFrEF receiving GDMT within 6 months		6 months