RECRUITING

Screening for earlY Heart Failure Diagnosis and Management in Primary Care or at HOme Using Natriuretic Peptides and echocardiographY "SYMPHONY-HF"

Conditions

Heart Failure Cardiovascular Diseases Screening Biomarker NT-proBNP Echocardiography Community Registry

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is an international 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.

Official Title

Screening for earlY Heart Failure Diagnosis and Management in Primary Care or at HOme Using Natriuretic Peptides and echocardiographY

Quick Facts

Study Start:2022-12-22

Study Completion:2032-12-21

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05919342

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Male or female ≥40 years of age * Informed consent * Two or more of the following risk factors 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 \[50% left main stem or \>70% left anterior descending, circumflex or right coronary artery\]) 2. An established diagnosis of diabetes (type 1 or type 2) 3. Persistent or permanent atrial fibrillation (not paroxysmal atrial fibrillation) 4. Previous ischemic or embolic stroke 5. Peripheral arterial disease (previous surgical or percutaneous revascularisation or a documented stenosis greater than 50% of a major peripheral arterial vessel). 6. 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). 7. Regular loop diuretic use (any dose at any dosing interval) for \>30 days. 8. 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).	* Inability to give informed consent e.g., due to significant cognitive impairment * Previous documented diagnosis of heart failure * Current 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

Inclusion Criteria

Exclusion Criteria

* Male or female ≥40 years of age
* Informed consent
* Two or more of the following risk factors 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 \[50% left main stem or \>70% left anterior descending, circumflex or right coronary artery\])
2. An established diagnosis of diabetes (type 1 or type 2)
3. Persistent or permanent atrial fibrillation (not paroxysmal atrial fibrillation)
4. Previous ischemic or embolic stroke
5. Peripheral arterial disease (previous surgical or percutaneous revascularisation or a documented stenosis greater than 50% of a major peripheral arterial vessel).
6. 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).
7. Regular loop diuretic use (any dose at any dosing interval) for \>30 days.
8. 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).

* Inability to give informed consent e.g., due to significant cognitive impairment
* Previous documented diagnosis of heart failure
* Current 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

Contacts and Locations

Study Contact

Mark C Petrie, MbChB

CONTACT

+44(0) 141 330 2677

mark.petrie@glasgow.ac.uk

Kieran F Docherty, MbChB

CONTACT

+44(0) 141 330 2677

kieran.docherty@glasgow.ac.uk

Principal Investigator

Mark C Petrie, MbChB

PRINCIPAL_INVESTIGATOR

University of Glasgow

Carolyn SP Lam

PRINCIPAL_INVESTIGATOR

Duke-NUS Graduate Medical School

Study Locations (Sites)

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: NHS Greater Glasgow and Clyde

Mark C Petrie, MbChB, PRINCIPAL_INVESTIGATOR, University of Glasgow
Carolyn SP Lam, PRINCIPAL_INVESTIGATOR, Duke-NUS Graduate Medical School

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-22

Study Completion Date2032-12-21

Study Record Updates

Study Start Date2022-12-22

Study Completion Date2032-12-21

Terms related to this study

Keywords Provided by Researchers

Screening
Biomarker
NT-proBNP
Echocardiography
Community
Registry

Additional Relevant MeSH Terms

Heart Failure
Cardiovascular Diseases