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

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.

Study Overview

• Status: Completed
• Conditions: Acute Heart Failure (AHF)
• Intervention / Treatment: Drug: Nitroglycerin (NTG)

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Hvidovre Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nitroglycerin; Infusion of intravenous nitroglycerin titrated towards a vasodilatory state which we predefined as a 20-30% decrease in mean arterial pressure (MAP) for 1.5 hours followed by a phase of 1.5 hours with no vasodilation.	Drug: Nitroglycerin (NTG); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke volume	Change in stroke volume (obtained from LiDCO) from baseline through vasodilation period.	From initiation of nitroglycerin infusion at time zero until study termination at 180 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulated urinary output (mL)	Measurement of cumulated urinary output after placement of a transurethral catheter.	From time zero until study termination at 180 minutes.
Mean arterial blood pressure		From time zero throughout the study period until termination at time 180 minutes.
Heart rate		From time zero throughout the study period until termination at time 180 minutes.
Cardiac output	Measured by echocardiography.	At baseline and at timepoints 90 minutes and 180 minutes.
Peripheral perfusion index	As obtained by photoplethysmography, where a higher numerical value may indicate better peripheral tissue perfusion.	From time zero throughout the study period until termination at time 180 minutes.
Systemic vascular resistance	[SVR=(MAP-RAP)×80/CO]	From time zero throughout the study period until termination at time 180 minutes.

Collaborators and Investigators

• Sponsor: Copenhagen University Hospital, Hvidovre

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Actual): November 30, 2025
• Study Completion (Actual): November 30, 2025

Study Registration Dates

• First Submitted: November 7, 2024
• First Submitted That Met QC Criteria: November 8, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Vasodilation; Cardiac function; Hemodynamics; Acute heart failure; Nitroglycerin; Stroke volume
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aneurysm; Organic Chemicals; Nitro Compounds; Nitroglycerin
• Other Study ID Numbers: Nitro-vers.1.1.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It is not possible for data to be shared due to legal reasons.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No