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Heart Failure With Preserved Ejection FractionPhase 2NCT04318145

Study to Evaluate Sex Differences in the Acute Effects of PL-3994 in Heart Failure Subjects

A Phase 2 study testing PL-3994 Aqueous Intravenous Solution Dose Ascention and PL-3994 Aqueous Intravenous Solution Single Dose in people with Heart Failure With Preserved Ejection Fraction, run by Palatin Technologies, Inc at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

A Multi-Center, Unblinded, Single-Arm Study to Evaluate Sex Differences in the Acute Effects of PL-3994 on Myocardial cGMP Enhancement and Hemodynamics in Heart Failure with Preserved Ejection Fraction Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
PL-3994 Aqueous Intravenous Solution Dose Ascention and PL-3994 Aqueous Intravenous Solution Single Dose
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
12 Nov 2020to 8 Dec 2023
Phase
Phase 2
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject has provided written informed consent.
  • Pre- or post-menopausal female or male age > 21 years
  • LVEF ≥ 45% by echocardiography within prior 6 months
  • Symptoms of HF requiring treatment with diuretics for ≥ 30 days prior to enrollment
  • Current symptoms of HF (NYHA class II-IV) at time of enrollment
  • 6. The subject has clinical indication for right heart catheterization for evaluation of HFpEF
  • Negative pregnancy test in a female of childbearing potential

Who cannot join

  • A subject who meets ANY of the following exclusion criteria must not be enrolled.
  • Orthostatic hypotension, systolic blood pressure <100 mm Hg, diastolic blood pressure < 50 mmHg.
  • Any prior echocardiogram with LVEF < 40%
  • Hemoglobin < 9 g/dl
  • eGFR < 30 mL/min/1.73 m2
  • Hemodynamically significant arrhythmias within prior 4 weeks
Show all 18Show fewer
  • Acute coronary syndrome, cardiac surgery, or percutaneous coronary intervention within prior 3 months
  • Any of the following cardiac diagnoses: active myocarditis, hypertrophic cardiomyopathy, > moderate regurgitant valvular disease, any valvular stenosis, restrictive cardiomyopathy (including amyloid, sarcoid, or hemochromatosis), constrictive pericarditis, complex congenital heart disease, or pulmonary arterial hypertension
  • Current need for IV inotropic medication
  • Currently taking nitrates or having stopped nitrates within 24 hours of visit
  • Currently taking antihistamines, antipsychotics, tri-cyclic antidepressants, catecholamines/related compounds, monoamine oxidase inhibitors, stimulants (including caffeine and nicotine), sympathomimetics, dopamine agonists. Additionally, medications that inhibit PDE activity will be prohibited during the study and for 5 half- lives prior to Day 1 so that cGMP measurements will not be affected
  • Currently hospitalized for HF
  • Any prior need for mechanical circulatory support
  • Previous adverse reaction to the study drug
  • Inability to comply with planned study procedures
  • Pregnant or nursing mothers
  • Participation in another study with an investigational drug or device within 30 days or a biologic study within 90 days prior to signing consent.
  • Study participants must use method of birth control that has been approved by the Study Doctor and males must not donate sperm during the study and for 30 days after the last dose of study drug.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Northwestern University

    Evanston, Illinois, 60208

Other trials in United States

About this study

Official title: A Multi-Center, Unblinded, Single-Arm Study to Evaluate Sex Differences in the Acute Effects of PL-3994 on Myocardial cGMP Enhancement and Hemodynamics in Heart Failure With Preserved Ejection Fraction

A Multi-Center, Unblinded, Single-Arm Study to Evaluate Sex Differences in the Acute Effects of PL-3994 on Myocardial cGMP Enhancement and Hemodynamics in Heart Failure with Preserved Ejection Fraction

Read the detailed description

Multi-center, unblinded, dose ascending, two-part pilot study involving Part A, up to 15 subjects for dose ascension and optimization (N=3 per dose level, up to 5 dose levels) and Part B, 40 patients (n=20 women, n=20 men), with a single dose of PL-3994 after which hemodynamics will be measured by pulmonary artery catheter and pulmonary artery (mixed venous) and coronary sinus blood sampling will be performed to measure cGMP levels during a 15-minute observation period.

The objective of this study is to evaluate the acute effects of a single dose of intravenous PL-3994 on hemodynamics and myocardial cGMP expression.

The following endpoints will be assessed:

  • Hemodynamics (including blood pressure, right atrial pressure, pulmonary artery pressure, pulmonary capillary wedge pressure, and cardiac output)
  • Myocardial cGMP expression via coronary sinus sampling
Being tested
PL-3994 Aqueous Intravenous Solution Dose Ascention, PL-3994 Aqueous Intravenous Solution Single Dose
Keywords
Heart Failure, Ejection Fraction
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PL-3994 Aqueous Intravenous Solution Dose AscentionDrug

    Also called PL-3994

    Following appropriate dilution, PL-3994 will be injected intravenously by site personnel as a bolus dose followed by continuous infusion

  • PL-3994 Aqueous Intravenous Solution Single DoseDrug

    Also called PL-3994

    Following appropriate dilution, PL-3994 will be injected intravenously by site personnel as a bolus dose followed by continuous infusion

Study groups in NCT04318145
Study groupRoleWhat they receive
Part A: PL-3994 Dose AscensionExperimentalDose ascension: up to 15 subjects with HFpEF. N = 3 per dose level, up to 5 dose levels.
Receives: Drug: PL-3994 Aqueous Intravenous Solution Dose Ascention
Part B: PL-3994 Single DoseExperimentalUp to 40 subjects with HFpEF (20 Females, 20 Males) will receive a single dose of PL-3994.
Receives: Drug: PL-3994 Aqueous Intravenous Solution Single Dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Dose Ascension

    Reaching the maximum tolderated dose (MTD) as defined by meeting stopping criteria.

    Measured: 1 day

  2. Part B: Coronary Sinus Levels

    Coronary sinus levels of cGMP post PL-3994 infusion as compared to baseline.

    Measured: 1 day

Secondary outcomes (6)

  1. Part B: Blood pressure measured in mmHg

    Measured at baseline (t=0) and at t=3, 6, 9, 12, and 15 minutes after the infusion of study drug.

    Measured: 1 day

  2. Part B: Heart rate measured in beats per minute

    Measured at baseline (t=0) and at t=3, 6, 9, 12, and 15 minutes after the infusion of study drug.

    Measured: 1 day

  3. Part B: Right atrial pressure measured in mmHg

    Measured at baseline (t=0) and at t=3, 6, 9, 12, and 15 minutes after the infusion of study drug.

    Measured: 1 day

  4. Part B: Pulmonary artery pressure measured in mmHg

    Measured at baseline (t=0) and at t=3, 6, 9, 12, and 15 minutes after the infusion of study drug.

    Measured: 1 day

  5. Part B: Pulmonary capillary wedge pressure measured in mmHg

    Measured at baseline (t=0) and at t=3, 6, 9, 12, and 15 minutes after the infusion of study drug.

    Measured: 1 day

  6. Part B: Cardiac output measured in L/min.

    Measured at baseline (t=0) and at t=3, 6, 9, 12, and 15 minutes after the infusion of study drug.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2020
  2. Study start12 Nov 2020
  3. Primary completion8 Dec 2023
  4. Study completion8 Dec 2023

Why it stopped: Study cancelled after Part A. Enrollment taking too long.

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
Part A: Single dose per subject, dose level ascension every 3 subjects. 5 dose levels are planned. An intermediate dose between planned doses may be chosen by the Sponsor/Investigator upon discussion after MTD is reached. Part B: Single dose, dose chosen from Part A.
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04318145
Sponsor's protocol ID
PL-3994-701
Status last verified
Dec 2025
First submitted
16 Mar 2020
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PL-3994 Aqueous Intravenous Solution Dose Ascention and PL-3994 Aqueous Intravenous Solution Single Dose in people with Heart Failure With Preserved Ejection Fraction, run by Palatin Technologies, Inc at 1 site in United States.

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 7 inclusion and 18 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: stopped early, as of the sponsor's last update on 15 Dec 2025. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was stopped early (reason given: Study cancelled after Part A. Enrollment taking too long.). Results are not available in the source record.

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?

Part A: Dose Ascension (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04318145.

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 15 Dec 2025.

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