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Prostacyclin Analogue

Treprostinil Diolamine for Pulmonary Hypertension (RECAPTURE Trial)

Phase 2
Waitlist Available
Led By Raymond Benza, MD
Research Sponsored by Mardi Gomberg -Maitland
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 32 weeks
Awards & highlights

RECAPTURE Trial Summary

This trial is testing a method to reduce high blood pressure in the lungs by using a device to manage fluid levels. If successful, it may help people with pulmonary hypertension caused by left heart problems.

Eligible Conditions
  • Pulmonary Hypertension Due to Left Heart Disease

RECAPTURE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~32 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 32 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants decreasing six-minute walk distance with oral treprostinil at Week 32
Number of participants maintaining normal lung impedance as measured by the ReDS vest at Week 32
Number of participants maintaining total pulmonary resistance as measured by CardioMEMS at Week 32
+4 more
Secondary outcome measures
Change in NT-proBNP
Change in cardiac efficiency
Change in cardiac index
+14 more

Side effects data

From 2018 Phase 3 trial • 690 Patients • NCT01560624
75%
Headache
69%
Diarrhoea
45%
Flushing
40%
Nausea
36%
Vomiting
23%
Dizziness
21%
Upper respiratory tract infection
18%
Pain in jaw
18%
Pain in extremity
16%
Viral upper respiratory tract infection
16%
Dyspnoea
14%
Palpitations
14%
Myalgia
13%
Cough
13%
Oedema peripheral
12%
Abdominal pain upper
12%
Arthralgia
11%
Fatigue
11%
Pulmonary hypertension
9%
Back pain
9%
Decreased appetite
8%
Abdominal pain
8%
Chest discomfort
8%
Abdominal discomfort
8%
Chest pain
8%
Abdominal distension
7%
Pyrexia
7%
Aesthenia
7%
Gastrooesophageal reflux disease
7%
Hypotension
7%
Bronchitis
6%
Syncope
6%
Insomnia
6%
Epistaxis
6%
Nasal congestion
6%
Right ventricular failure
5%
Anaemia
5%
Gastritis
5%
Oedema
5%
Urinary tract infection
5%
Rash
5%
Pneumonia
5%
Dyspepsia
5%
Constipation
4%
Influenza
3%
Oropharyngeal pain
3%
Muscle spasms
1%
Gastrointestinal haemorrhage
1%
Gastroenteritis
1%
Respiratory failure
1%
Septic shock
1%
Atrial fibrillation
1%
Acute kidney injury
1%
Dyspnoea exertional
1%
Hyperthyroidism
1%
Appendicitis
1%
Gastritis erosive
1%
Lower respiratory tract infection
1%
Cardiac failure
1%
Lung infection
1%
Hypoxia
1%
Chronic obstructive pulmonary disease
1%
Circulatory collapse
1%
Sudden death
1%
Systemic lupus erythematosus
100%
80%
60%
40%
20%
0%
Study treatment Arm
UT-15C
Placebo

RECAPTURE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Oral TreprostinilExperimental Treatment1 Intervention
Drug - oral treprostinil
Group II: Fluid ManagementActive Control1 Intervention
Fluid management protocol only
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treprostinil Diolamine
2012
Completed Phase 3
~690

Find a Location

Who is running the clinical trial?

Mardi Gomberg -MaitlandLead Sponsor
Mardi Gomberg -Maitland MD, MScLead Sponsor
Ohio State UniversityOTHER
827 Previous Clinical Trials
502,751 Total Patients Enrolled

Frequently Asked Questions

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

Has Treprostinil Diolamine received the authority's authorization?

"Our experts at Power assigned Treprostinil Diolamine a score of 2, as there is evidence showing it to be safe but not yet any proof that it is effective."

Answered by AI

Is there a criteria for admission to the research trial?

"This research initiative is open to 30 individuals, aged 18-85, suffering from cardiac conditions. To be considered, applicants must also fulfill the following criteria: The subject has a LVEF ≥45% and is on suitable medications (excluding anticoagulants/diuretics changed 14 days prior), possesses an implanted CardioMEMS device for at least one month beforehand, have total lung capacity of 60%, FEV1 of 50%, DLCO > 32%; in addition they should demonstrate reliable communication with study personnel regarding their condition and adherence to protocol requirements. Subjects may not be undergoing long-term treatment with anti-inflammatory or"

Answered by AI

In what situations is Treprostinil Diolamine usually prescribed?

"Treprostinil Diolamine is the usual treatment for NYHA functional class III pulmonary arterial hypertension, as well as WHO functional classes II and III of this condition."

Answered by AI

What is the aggregate of individuals participating in this experiment?

"At this current moment, no further applicants are being sought for this trial. According to the records posted on clinicaltrials.gov, which were last updated on May 10th 2022 and first published April 1st 2023, enrollment has been completed. However, if you are pursuing other studies related to cardiac diseases there are presently 1067 trials actively recruiting patients while 8 trials require participants for Treprostinil Diolamine treatment protocols."

Answered by AI

Are there any existing reports on the efficacy of Treprostinil Diolamine?

"Treprostinil Diolamine was first investigated at Hospital Italiano de Buenos Aires in 2018 and there have been 46 completed studies. 8 trials are presently recruiting participants, with a considerable amount of these located in Washington DC."

Answered by AI

Are there any available positions in this trial for volunteer participants?

"Judging by the details posted on clinicaltrials.gov, this specific medical trial is not currently recruiting participants. The initial announcement was made in April of 2023 and had its last update in May 2022; nevertheless, there are still 1,075 other trials that require volunteers right now."

Answered by AI

Is this trial pioneering a new therapeutic approach?

"Since 2018, the United Therapeutics team has conducted research into Treprostinil Diolamine, culminating in a Phase 3 drug approval after an initial trial involving 76 participants. Currently there are 8 active studies regarding this medication hosted across 93 cities and 6 countries globally."

Answered by AI

What is the primary focus of this experiment?

"This medical trial's primary objective, to be evaluated over a 16 week period, is to calculate the total pulmonary resistance of participants in Woods Units at Week 16. Secondary endpoints include measuring changes in right ventricular power (W), stroke volume index (mL/m2) and cardiac efficiency (mL/mmHg) with CardioMEMS from Baseline to Weeks 16 & 32."

Answered by AI

Are minors within the purview of this research initiative?

"To be enrolled in this trial, individuals must be between the age of 18 and 85."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Telemonitoring to Treat Group 2 Pulmonary Hypertension
Mardi Gomberg -Maitland MD, MSc 2023. "Telemonitoring to Treat Group 2 Pulmonary Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04882774.
~0 spots leftby Apr 2025
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