Clinical trial NCT06682260: Evaluating the Effects of Nitroglycerin on Heart Function and Urinary Output in Patients with Acute Heart Failure
Official title: Impact of Nitroglycerin-induced Vasodilation on Stroke Volume and Diuretic Response in Acute Heart Failure: a Protocol for a Mechanistic Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Acute Heart Failure (AHF)
Keywords: Acute heart failure
Vasodilation
Nitroglycerin
Hemodynamics
Stroke volume
Cardiac function
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Stroke volume
timeFrame: From initiation of nitroglycerin infusion at time zero until study termination at 180 minutes.
Secondary outcomes:
measure: Cumulated urinary output (mL)
timeFrame: From time zero until study termination at 180 minutes.
measure: Mean arterial blood pressure
timeFrame: From time zero throughout the study period until termination at time 180 minutes.
measure: Heart rate
timeFrame: From time zero throughout the study period until termination at time 180 minutes.
measure: Cardiac output
timeFrame: At baseline and at timepoints 90 minutes and 180 minutes.
measure: Peripheral perfusion index
timeFrame: From time zero throughout the study period until termination at time 180 minutes.
measure: Systemic vascular resistance
timeFrame: From time zero throughout the study period until termination at time 180 minutes.
Other outcomes:
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