Pulmonary Arterial HypertensionNCT04090866
Cardiac Metabolic Remodeling After Pulmonary Vasodilator Therapy in Pulmonary Arterial Hypertension: A Pilot Study
An observational study of Pulmonary Arterial Hypertension and Right-Sided Heart Failure, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Pulmonary arterial hypertension(PAH) is associated with the development of right heart failure. In the setting of heart failure, the heart shifts to increasing dependence on glucose metabolism. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Arterial Hypertension, Right-Sided Heart Failure
- What is being tested?
- PET/MRI
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2019to 21 Jul 2020
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with IPAH or CTD-PAH
Who may be able to join
- World Health Organization(WHO) group PAH secondary into idiopathic pulmonary arterial hypertension(IPAH) or connective tissue disease associated pulmonary arterial hypertension (CTDPAH)
- New York Heart Association (NYHA) classification I - III heart failure
- Vasodilator therapy naive
- Able to provide informed consent
Who cannot join
- Metabolic disorders such as uncontrolled diabetes (A1c > 8%) that may interfere with FDG uptake
- Baseline 6-minute walk distance (6MWD) < 400 feet or NYHA class IV heart failure
- Musculoskeletal abnormalities that would prevent exercise
- Contraindications to MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison
Madison, Wisconsin, 53792
About this study
Pulmonary arterial hypertension(PAH) is associated with the development of right heart failure. In the setting of heart failure, the heart shifts to increasing dependence on glucose metabolism. In this study, the investigators will perform cardiac positron emission tomography/magnetic resonance imaging (PET/MRI) scans to measure glucose metabolism in the heart before and after initiation of pulmonary vasodilator therapy for pulmonary arterial hypertension.
Read the detailed description
Pulmonary arterial hypertension is associated with the development of right heart failure. In the setting of heart failure, the heart shifts to increasing dependence on glucose metabolism. In this study, the investigators will perform cardiac positron emission tomography/magnetic resonance imaging (PET/MRI) scans to measure glucose metabolism in the heart before and after initiation of pulmonary vasodilator therapy for pulmonary arterial hypertension. By utilizing a rest-exercise protocol and continuous PET imaging acquisition, we can capture real-time changes in glucose uptake in the heart in response to acute exercise. By coupling these measures of dynamic glucose utilization with MRI-based cardiac function, we will determine cardiac metabolic efficiency.
- Being tested
- PET/MRI
- Keywords
- pulmonary arterial hypertension, right-sided heart failure, metabolism, PET/MRI
- Medical subject headings
- Pulmonary Arterial Hypertension, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MRIOther
Positron Emission Tomograph/Magnetic Resonance Imaging - participants will undergo PET/MRI prior to initiation of pulmonary vasodilator therapy and again 4-6 months after initiation of therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to augment glucose uptake ("substrate flexibility"), defined as change in rate of glucose uptake from rest to exercise
Substrate flexibility is defined as the change in myocardial to blood pool glucose uptake rate from rest to exercise.
Measured: 6 months
Secondary outcomes (1)
Change in substrate flexibility after initiation of pulmonary vasodilator therapy
Substrate flexibility is defined as the change in myocardial to blood pool glucose uptake rate from rest to exercise. Substrate flexibility before and after pulmonary vasodilator therapy will be compared.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start14 Nov 2019
- Primary completion21 Jul 2020
- Study completion21 Jul 2020
Why it stopped: PI and sponsor will re-open study at new institution, will not transfer data due to COVID-19 situation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- United Therapeutics
- Responsible party
- Sponsor
- Investigators
- Kara Goss, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090866
- Sponsor's protocol ID
- 2019-0286
- Other IDs
- A534285, SMPH/MEDICINE/MEDICINE*P, Protocol Version 8/2/2019
- Status last verified
- Jul 2020
- First submitted
- 12 Sep 2019
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Metabolic Remodeling After Pulmonary Vasodilator Therapy in Pulmonary Arterial Hypertension: A Pilot Study
- ClinicalTrials.gov ID
- NCT04090866
- Acronym / sponsor ID
- 2019-0286
- Keywords
- pulmonary arterial hypertension, right-sided heart failure, metabolism, PET/MRI
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI and sponsor will re-open study at new institution, will not transfer data due to COVID-19 situation
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- United Therapeutics
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- 21 Jul 2020 (actual)
- Study completion
- 21 Jul 2020 (actual)
- First posted
- 16 Sep 2019 (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.
Pulmonary arterial hypertension(PAH) is associated with the development of right heart failure. In the setting of heart failure, the heart shifts to increasing dependence on glucose metabolism. In this study, the investigators will perform cardiac positron emission tomography/magnetic resonance imaging (PET/MRI) scans to measure glucose metabolism in the heart before and after initiation of pulmonary vasodilator therapy for pulmonary arterial hypertension.
Detailed description
Pulmonary arterial hypertension is associated with the development of right heart failure. In the setting of heart failure, the heart shifts to increasing dependence on glucose metabolism. In this study, the investigators will perform cardiac positron emission tomography/magnetic resonance imaging (PET/MRI) scans to measure glucose metabolism in the heart before and after initiation of pulmonary vasodilator therapy for pulmonary arterial hypertension. By utilizing a rest-exercise protocol and continuous PET imaging acquisition, we can capture real-time changes in glucose uptake in the heart in response to acute exercise. By coupling these measures of dynamic glucose utilization with MRI-based cardiac function, we will determine cardiac metabolic efficiency.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with IPAH or CTD-PAH
Key inclusion criteria (4 listed)
- World Health Organization(WHO) group PAH secondary into idiopathic pulmonary arterial hypertension(IPAH) or connective tissue disease associated pulmonary arterial hypertension (CTDPAH)
- New York Heart Association (NYHA) classification I - III heart failure
- Vasodilator therapy naive
- Able to provide informed consent
Key exclusion criteria (4 listed)
- Metabolic disorders such as uncontrolled diabetes (A1c > 8%) that may interfere with FDG uptake
- Baseline 6-minute walk distance (6MWD) < 400 feet or NYHA class IV heart failure
- Musculoskeletal abnormalities that would prevent exercise
- Contraindications to MRI
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 |
|---|---|---|
| PET/MRIPositron Emission Tomograph/Magnetic Resonance Imaging - participants will undergo PET/MRI prior to initiation of pulmonary vasodilator therapy and again 4-6 months after initiation of therapy | Other | – |
Primary outcome
Ability to augment glucose uptake ("substrate flexibility"), defined as change in rate of glucose uptake from rest to exercise
Time frame: 6 months
Substrate flexibility is defined as the change in myocardial to blood pool glucose uptake rate from rest to exercise.
1 secondary outcome
Change in substrate flexibility after initiation of pulmonary vasodilator therapy
Time frame: 6 months
Results and safety
The study was stopped early (reason given: PI and sponsor will re-open study at new institution, will not transfer data due to COVID-19 situation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Kara Goss, MD principal investigator
University of Wisconsin, Madison
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 Arterial Hypertension and Right-Sided Heart Failure, run by University of Wisconsin, Madison 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 4 inclusion and 4 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 27 Jul 2020. 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?
The study was stopped early (reason given: PI and sponsor will re-open study at new institution, will not transfer data due to COVID-19 situation). 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?
Ability to augment glucose uptake ("substrate flexibility"), defined as change in rate of glucose uptake from rest to exercise (time frame: 6 months). 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 27 Jul 2020.