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PL-3994 Aqueous Intravenous Solution Single Dose for Heart Failure

Phase 2
Waitlist Available
Led By Sangiv J. Shah, MD
Research Sponsored by Palatin Technologies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pre- or post-menopausal female or male age > 21 years
The subject has clinical indication for right heart catheterization for evaluation of HFpEF
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights

Study Summary

This trial will look at whether a new drug called PL-3994 can help improve heart function in people with heart failure and preserved ejection fraction. The trial will also look at whether there are any sex differences in how well the drug works.

Eligible Conditions
  • Diastolic Heart Failure

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are a man or a woman who is older than 21, regardless of whether you have gone through menopause or not.
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You need to undergo a procedure called right heart catheterization to evaluate a type of heart disease called HFpEF.
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You have been taking medication to help with heart failure symptoms for at least 30 days before joining the study.
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You are currently experiencing symptoms of heart failure categorized as class II-IV according to the New York Heart Association (NYHA) classification system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: Dose Ascension
Part B: Coronary Sinus Levels
Secondary outcome measures
Part B: Blood pressure measured in mmHg
Part B: Cardiac output measured in L/min.
Part B: Heart rate measured in beats per minute
+3 more

Side effects data

From 2014 Phase 4 trial • 40 Patients • NCT01602692
40%
Nausea
10%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tumescent Solution With Dilute Epinephrine
Tumescent Solution With Dilute Lidocaine and Epinephrine

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part B: PL-3994 Single DoseExperimental Treatment1 Intervention
Up to 40 subjects with HFpEF (20 Females, 20 Males) will receive a single dose of PL-3994.
Group II: Part A: PL-3994 Dose AscensionExperimental Treatment1 Intervention
Dose ascension: up to 15 subjects with HFpEF. N = 3 per dose level, up to 5 dose levels.

Find a Location

Who is running the clinical trial?

Palatin TechnologiesLead Sponsor
6 Previous Clinical Trials
2,070 Total Patients Enrolled
Palatin Technologies, IncLead Sponsor
10 Previous Clinical Trials
2,543 Total Patients Enrolled
Sangiv J. Shah, MDPrincipal InvestigatorNorthwestern University Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has PL-3994 Aqueous Intravenous Solution Single Dose attained the authorization of the FDA?

"Our internal evaluation placed PL-3994 Aqueous Intravenous Solution Single Dose at a 2 on the safety scale due to Phase 2 trial status, which signals some evidence of its security but no proof of efficacy."

Answered by AI

Are there any prior studies conducted involving PL-3994 Aqueous Intravenous Solution Single Dose?

"Presently, there is a single medical trial examining the effects of PL-3994 Aqueous Intravenous Solution Single Dose with none currently in phase 3. The primary research sites for this treatment are found within Baltimore, Maryland and two other locations."

Answered by AI

What outcomes is this trial trying to accomplish?

"Palatin Technologies, the study sponsor, has determined that Part B: Coronary Sinus Levels will be monitored as the main outcome over a 24-hour span. The additional secondary endpoints being assessed include Part B: Heart rate (measured in beats per minute) at baseline and post drug infusion intervals of 3, 6, 9, 12 and 15 minutes; Part B: Cardiac output (measured in L/min.) likewise measured pre-drug administration and after set time points; Lastly, Pulmonary capillary wedge pressure is also recorded for analysis (in mmHg)."

Answered by AI

How many individuals are enrolled in this medical experiment?

"Yes, the information on clinicaltrials.gov shows that this investigation is actively recruiting participants. First posted November 12th 2020, it was last updated December 13th 2021 and seeks to enroll 55 patients across 2 medical centres."

Answered by AI

Are there still opportunities for individuals to partake in this research endeavor?

"According to clinicaltrials.gov, this medical trial is still open for recruitment. It was first made available on November 12th 2020 and its details were last modified December 13rd 2021."

Answered by AI

Is this an innovative clinical trial?

"Research into PL-3994 Aqueous Intravenous Solution Single Dose has been ongoing since 2020, initiated by Palatin Technologies. After the initial clinical trial involving 55 participants in 2020, the drug successfully passed its Phase 2 phase of development. At present there is only one active study concerning this medication which is being sponsored by Palatin Technologies again."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate Sex Differences in the Acute Effects of PL-3994 in Heart Failure Subjects
2020. "Study to Evaluate Sex Differences in the Acute Effects of PL-3994 in Heart Failure Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04318145.
~12 spots leftby Apr 2025
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