Evaluating the Effects of Nitroglycerin on Heart Function and Urinary Output in Patients With Acu… (NCT06682260) | Clinical Trial Compass
CompletedPhase 4
Evaluating the Effects of Nitroglycerin on Heart Function and Urinary Output in Patients With Acute Heart Failure
Denmark21 participantsStarted 2025-02-01
Plain-language summary
This study aims to understand how nitroglycerin affects patients with acute heart failure, a condition where the heart struggles to pump blood effectively, leading to fluid buildup and breathing difficulties. Nitroglycerin relaxes blood vessels to ease the heart's workload and may help reduce fluid buildup. The investigators hypothesize that nitroglycerin can increase blood flow from the heart and promote urine production, which may reduce congestion in AHF patients. By studying heart function, blood volume, and fluid levels during treatment, the goal is to identify which patients may benefit most from nitroglycerin therapy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years
* Clinical diagnosis of AHF requiring hospitalization
* Systolic blood pressure ≥85 mmHg
* Echocardiographic signs of cardiac dysfunction, by at least one of
* Left ventricular ejection fraction ≤45%
* Abnormal left ventricular filling with dilatation of the left atrium
* Elevated filling pressures (systolic pulmonary artery pressure\>30, dilated vena cava inferior or E/é\>10)
* Significant left-sided heart valve disease
Exclusion Criteria:
* Ongoing ventricular taky- or brady-arrythmias or supraventricular arrhythmias with heart rate \> 180 or \< 40 bpm.
* Retinopathy or intraocular lens implantation (contraindication to Valsalva maneuver)
* Recent myocardial infarction or thromboembolic events.
* Intake of sildenafil or vardenafil withing 24 h and tadalafil within 48 h.
* Absolute contraindication for vasodilation using nitroglycerin as assessed by treating physician
* Intravenous administration of furosemide within 2 hours of baseline measurements
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial looked at how nitroglycerin affects stroke volume in acute heart failure — can you explain what stroke volume tells us about how my heart is functioning, and why that matters for my treatment?
2Since this is a Phase 4 trial that has already completed, does that mean the results are available, and if so, what did they find about nitroglycerin's effect on heart function and urine output in patients like me?
3Nitroglycerin is already an approved medication — so how does what this trial was testing differ from how it's currently used, and could its findings change the way you might use it in my care?
4Given that this trial studied both heart function and urinary output together, does that reflect a specific concern about how the kidneys and heart interact during acute heart failure, and is that something I should be monitoring closely?
5Are there standard treatments for acute heart failure that you'd recommend I consider first, and how would the findings from a study like this one factor into your decision about my treatment plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Stroke volume
Timeframe: From initiation of nitroglycerin infusion at time zero until study termination at 180 minutes.