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

NCT ID: NCT06682260

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-10-31

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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Nitroglycerin (NTG)

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Copenhagen University Hospital, Hvidovre

OTHER

Sponsor Role: lead

Responsible Party

Frederik Lau

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Frederik F. Lau, Medical doctor

Role: CONTACT

frederik.faergemann.lau.02@regionh.dk

+45 42241636

Other Identifiers

Nitro-vers.1.1.

Identifier Type: -

Identifier Source: org_study_id