Pulmonary HypertensionNCT07224906
Observational Study of Patients Undergoing Diagnostic Right Heart Catheterization
An observational study of Pulmonary Hypertension and Congestive Heart Failure(CHF), run by HemoCept Inc. at 1 site in United States.
Trial summary
The objective of this observational pilot study is to collect HemoCept device data from subjects undergoing diagnostic right heart catheterization (RHC) procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension, Congestive Heart Failure(CHF), Valve Disease, Heart
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Subjects above the age of 18 who meet all inclusion/exclusion criteria.
Who may be able to join
- Subjects or representatives must have voluntarily signed the informed consent form before any study related procedures.
- Subjects can be any gender but must be age 18 or older.
- Subject is able and willing to provide informed consent and HIPAA authorization.
- Subject is able and willing to meet all study requirements.
- Scheduled for a diagnostic right heart catheterization (RHC-only or combined RHC+LHC; left-heart-only procedures are not eligible)
Who cannot join
- Subject is pregnant, breastfeeding, or intends to become pregnant during this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boulder Heart
Boulder, Colorado, 80303
Katharine Adkins, 303-442-2395, kathari.adkins@bch.org
Scott Blois, MD
About this study
Official title: Observational Study of the HemoCept Device During Right Heart Catheterization at Boulder Heart
The objective of this observational pilot study is to collect HemoCept device data from subjects undergoing diagnostic right heart catheterization (RHC) procedures.
- Medical subject headings
- Hypertension, Pulmonary, Heart Failure, Heart Valve Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between device measurements and Pulmonary Capillary Wedge Pressure
The correlation of HemoCept device measurements to Pulmonary Capillary Wedge Pressure (PCWP) measured during right heart catheterization.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2025
- Study start1 Dec 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HemoCept Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224906
- Sponsor's protocol ID
- PRT-020
- Status last verified
- Apr 2026
- First submitted
- 31 Oct 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the HemoCept Device During Right Heart Catheterization at Boulder Heart
- ClinicalTrials.gov ID
- NCT07224906
- Acronym / sponsor ID
- PRT-020
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- HemoCept Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 5 Nov 2025 (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.
The objective of this observational pilot study is to collect HemoCept device data from subjects undergoing diagnostic right heart catheterization (RHC) procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects above the age of 18 who meet all inclusion/exclusion criteria.
Key inclusion criteria (5 listed)
- Subjects or representatives must have voluntarily signed the informed consent form before any study related procedures.
- Subjects can be any gender but must be age 18 or older.
- Subject is able and willing to provide informed consent and HIPAA authorization.
- Subject is able and willing to meet all study requirements.
- Scheduled for a diagnostic right heart catheterization (RHC-only or combined RHC+LHC; left-heart-only procedures are not eligible)
Key exclusion criteria (1 listed)
- Subject is pregnant, breastfeeding, or intends to become pregnant during this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between device measurements and Pulmonary Capillary Wedge Pressure
Time frame: Day 1
The correlation of HemoCept device measurements to Pulmonary Capillary Wedge Pressure (PCWP) measured during right heart catheterization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension and Congestive Heart Failure(CHF), run by HemoCept 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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 13 Apr 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 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katharine Adkins (303-442-2395, kathari.adkins@bch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between device measurements and Pulmonary Capillary Wedge Pressure (time frame: Day 1). 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 13 Apr 2026.