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Completed

NCT Number: NCT06682260

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

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.

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Key information

Conditions

Acute Heart Failure (AHF) Aneurysm Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hvidovre Hospital

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Stroke volume

    Time frame: From 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 outcomes

  1. Cumulated urinary output (mL)

    Time frame: From time zero until study termination at 180 minutes.

    Measurement of cumulated urinary output after placement of a transurethral catheter.

  2. Mean arterial blood pressure

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

  3. Heart rate

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

  4. Cardiac output

    Time frame: At baseline and at timepoints 90 minutes and 180 minutes.

    Measured by echocardiography.

  5. Peripheral perfusion index

    Time frame: From 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.

  6. Systemic vascular resistance

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

    [SVR=(MAP-RAP)×80/CO]

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital, Hvidovre

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 12, 2024
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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