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

NCT06682260 | Completed Phase 4

• 1 other identifier: Nitro-vers.1.1.
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Heart Failure (AHF)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Cumulated urinary output (mL)

  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

  At baseline and at timepoints 90 minutes and 180 minutes.

• Peripheral perfusion index

  From time zero throughout the study period until termination at time 180 minutes.

Study Arms (1)

Nitroglycerin

EXPERIMENTAL

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)

Interventions

Nitroglycerin (NTG) DRUG

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.

Nitroglycerin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead

Study Sites (1)

Hvidovre Hospital

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Aneurysm

Interventions

Nitroglycerin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 12, 2024
• Study Start: February 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: March 18, 2026

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)