NCT05919342 · NHS Greater Glasgow and Clyde
Screening for earlY Heart Failure Diagnosis and Management in Primary Care or at HOme Using Natriuretic Peptides and echocardiographY "SYMPHONY-HF"
(SYMPHONY-HF)
What this study is about
This is an international forward-looking, multicentre, unblinded, randomised-controlled trial. The primary aim is to assess a targeted screening strategy to detect undiagnosed heart failure in high-risk patients.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or female ≥40 years of age
- Informed consent
- Two or more of the following risk factors 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 \[50% left main stem or \>70% left anterior descending, circumflex or right coronary artery\])
- An established diagnosis of diabetes (type 1 or type 2)
- 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).
Exclusion criteria
- 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
Where
- Cleveland, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 4, 2023 · Source of record for eligibility and locations