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Evaluating the Effects of Nitroglycerin on Heart Function and Urinary Output in Patients With Acute Heart Failure

Impact of Nitroglycerin-induced Vasodilation on Stroke Volume and Diuretic Response in Acute Heart Failure: A Protocol for a Mechanistic Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06682260
Enrollment
21
Registered
2024-11-12
Start date
2025-02-01
Completion date
2025-11-30
Last updated
2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Heart Failure (AHF)

Keywords

Acute heart failure, Vasodilation, Nitroglycerin, Hemodynamics, Stroke volume, Cardiac function

Brief 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.

Interventions

Infusion of intravenous nitroglycerin beginning at 2 microgram/kg/min (2 ml/hour) and titrated with the aim of a MAP reduction of 20-30%. Infusion rate will not be increased after the first 30 minutes and is limited to 0.1 µg/kg/min to 5 µg/kg/min.

Sponsors

Copenhagen University Hospital, Hvidovre
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Stroke volumeFrom initiation of nitroglycerin infusion at time zero until study termination at 180 minutes.Change in stroke volume (obtained from LiDCO) from baseline through vasodilation period.

Secondary

MeasureTime frameDescription
Cumulated urinary output (mL)From time zero until study termination at 180 minutes.Measurement of cumulated urinary output after placement of a transurethral catheter.
Mean arterial blood pressureFrom time zero throughout the study period until termination at time 180 minutes.
Heart rateFrom time zero throughout the study period until termination at time 180 minutes.
Cardiac outputAt baseline and at timepoints 90 minutes and 180 minutes.Measured by echocardiography.
Peripheral perfusion indexFrom time zero throughout the study period until termination at time 180 minutes.As obtained by photoplethysmography, where a higher numerical value may indicate better peripheral tissue perfusion.
Systemic vascular resistanceFrom time zero throughout the study period until termination at time 180 minutes.\[SVR=(MAP-RAP)×80/CO\]

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026