Acute Heart Failure (AHF)Phase 4NCT06682260
Evaluating the Effects of Nitroglycerin on Heart Function and Urinary Output in Patients With Acute Heart Failure
A Phase 4 study testing Nitroglycerin (NTG) in people with Acute Heart Failure (AHF), run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure (AHF)
- What is being tested?
- Nitroglycerin (NTG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2025to 30 Nov 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Nitroglycerin-induced Vasodilation on Stroke Volume and Diuretic Response in Acute Heart Failure: A Protocol for a Mechanistic Trial
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)
- Being tested
- Nitroglycerin (NTG)
- Keywords
- Acute heart failure, Vasodilation, Nitroglycerin, Hemodynamics, Stroke volume, Cardiac function
- Medical subject headings
- Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Nitroglycerin (NTG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke volume
Change in stroke volume (obtained from LiDCO) from baseline through vasodilation period.
Measured: From initiation of nitroglycerin infusion at time zero until study termination at 180 minutes.
Secondary outcomes (6)
Cumulated urinary output (mL)
Measurement of cumulated urinary output after placement of a transurethral catheter.
Measured: From time zero until study termination at 180 minutes.
Mean arterial blood pressure
Measured: From time zero throughout the study period until termination at time 180 minutes.
Heart rate
Measured: From time zero throughout the study period until termination at time 180 minutes.
Cardiac output
Measured by echocardiography.
Measured: At baseline and at timepoints 90 minutes and 180 minutes.
Peripheral perfusion index
As obtained by photoplethysmography, where a higher numerical value may indicate better peripheral tissue perfusion.
Measured: From time zero throughout the study period until termination at time 180 minutes.
Systemic vascular resistance
[SVR=(MAP-RAP)×80/CO]
Measured: From time zero throughout the study period until termination at time 180 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Feb 2025
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart Failure (AHF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederik Lau, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682260
- Sponsor's protocol ID
- Nitro-vers.1.1.
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not possible for data to be shared due to legal reasons.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nitroglycerin-induced Vasodilation on Stroke Volume and Diuretic Response in Acute Heart Failure: A Protocol for a Mechanistic Trial
- ClinicalTrials.gov ID
- NCT06682260
- Acronym / sponsor ID
- Nitro-vers.1.1.
- Conditions
- Acute Heart Failure (AHF)
- Keywords
- Acute heart failure, Vasodilation, Nitroglycerin, Hemodynamics, Stroke volume, Cardiac function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nitroglycerin | Experimental | Drug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Clinical diagnosis of AHF requiring hospitalization
- Systolic blood pressure ≥85 mmHg
- Echocardiographic signs of cardiac dysfunction, by at least one of
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Nitroglycerin |
Primary outcome
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.
6 secondary outcomes
Cumulated urinary output (mL)
Time frame: From time zero until study termination at 180 minutes.
Mean arterial blood pressure
Time frame: From time zero throughout the study period until termination at time 180 minutes.
Heart rate
Time frame: From time zero throughout the study period until termination at time 180 minutes.
Cardiac output
Time frame: At baseline and at timepoints 90 minutes and 180 minutes.
Peripheral perfusion index
Time frame: From time zero throughout the study period until termination at time 180 minutes.
Systemic vascular resistance
Time frame: From time zero throughout the study period until termination at time 180 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No. It is not possible for data to be shared due to legal reasons.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nitroglycerin (NTG) in people with Acute Heart Failure (AHF), run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke volume (time frame: From initiation of nitroglycerin infusion at time zero until study termination at 180 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.