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

Phase 4

Not yet recruiting

• Conditions: Acute Heart Failure (AHF)
• Interventions: Drug: Nitroglycerin (NTG)

• Registration Number: NCT06682260
• Lead Sponsor: Copenhagen University Hospital, Hvidovre

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-07
• Study First Submitted QC: 2024-11-08
• Last Update Submitted: 2024-11-08
• Study First Posted: 2024-11-11
• Last Update Posted: 2024-11-11
• Study Start: 2025-01-01
• Primary Completion: 2025-06-30
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nitroglycerin	Nitroglycerin (NTG)	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.

Primary Outcome Measures

Name	Time	Method
Stroke volume	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 Outcome Measures

Name	Time	Method
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 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.	Measured by echocardiography.
Peripheral perfusion index	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.
Systemic vascular resistance	From time zero throughout the study period until termination at time 180 minutes.	\[SVR=(MAP-RAP)×80/CO\]