Diastolic Heart FailurePVRNCT02275793
The Regulation of Pulmonary Vascular Resistance in Patients With Heart Failure
An observational study of Diastolic Heart Failure and Pulmonary Hypertension, run by University of Toledo Health Science Campus at 1 site in United States.
Trial summary
Peripheral blood and blood following a pulmonary wedge pressure will be obtained from patients undergoing right heart catheterizations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diastolic Heart Failure, Pulmonary Hypertension
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Sep 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will study a cohort of patients that will be recruited from the cath lab during diagnositic heart catheterization
Who may be able to join
- Age >18 years
- Ability to provide informed consent.
- Presenting for cardiac catheterization for evaluation of heart disease
- Ejection Fraction > 50%
Who cannot join
- Unable to provide informed consent.
- Unable or unwilling to comply with the protocol and follow up.
- Infiltrative cardiomyopathy
- Constrictive pericarditis
- Severe valvular disease
- Comorbid status with life expectancy <3 years
Show all 13Show fewer
- Right ventricular dysplasia
- Congenital heart disease
- On immunosuppressive drugs.
- Patients who has heart transplant.
- Ejection Fraction < 50%
- Mean Pulmonary Artery Pressure <25
- Wedge pressure <15
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Toledo, Health Science Campus
Toledo, Ohio, 43606
About this study
Peripheral blood and blood following a pulmonary wedge pressure will be obtained from patients undergoing right heart catheterizations.
Read the detailed description
It is well known that left sided heart disease can lead to pulmonary hypertension via a number of proposed mechanisms. The purpose in this study is to identify biomarkers in pulmonary hypertension to further understand the pathophysiology of this disease in patients with heart disease.Patients are recruited in the cardiac catheterization lab, which are undergoing right heart catheterization as per their plan of care established by their primary cardiologist. During the procedure, we will ask the performing cardiologist to obtain a blood sample of 40-50 milliliters from the catheter that they are using during the procedure. These blood samples will be sent for analysis of biomarkers. The patient will then have an echocardiogram done 1 year from their heart catheterization.
- Conditions
- Diastolic Heart Failure, Pulmonary Hypertension
- Medical subject headings
- Heart Failure, Diastolic, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| high PH and normal PVR | Group I, diastolic heart failure with high PH and normal PVR | |
| high PH and high PVR | Group II, diastolic heart failure with high PH and High PVR | |
| normal PH and normal PVR | Group III, no heart failure, normal PH and normal PVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Checking vital statistics on each patient at one year
Measured: 1 year
Secondary outcomes (1)
Morbidity
Checking vital statistics on each patient at one year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startSep 2011
- Primary completionJun 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastolic Heart FailureStudies 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toledo Health Science Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samer Khouri, MD, Principal investigator, University of Toledo Health Science Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275793
- Sponsor's protocol ID
- PVR
- Acronym
- PVR
- Status last verified
- Sep 2019
- First submitted
- 11 Dec 2013
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Regulation of Pulmonary Vascular Resistance in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT02275793
- Acronym / sponsor ID
- PVR / PVR
- Conditions
- Diastolic Heart Failure, Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Toledo Health Science CampusUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 27 Oct 2014 (estimated)
- 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.
Peripheral blood and blood following a pulmonary wedge pressure will be obtained from patients undergoing right heart catheterizations.
Detailed description
It is well known that left sided heart disease can lead to pulmonary hypertension via a number of proposed mechanisms. The purpose in this study is to identify biomarkers in pulmonary hypertension to further understand the pathophysiology of this disease in patients with heart disease.Patients are recruited in the cardiac catheterization lab, which are undergoing right heart catheterization as per their plan of care established by their primary cardiologist. During the procedure, we will ask the performing cardiologist to obtain a blood sample of 40-50 milliliters from the catheter that they are using during the procedure. These blood samples will be sent for analysis of biomarkers. The patient will then have an echocardiogram done 1 year from their heart catheterization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| high PH and normal PVR | – | –Group I, diastolic heart failure with high PH and normal PVR |
| high PH and high PVR | – | –Group II, diastolic heart failure with high PH and High PVR |
| normal PH and normal PVR | – | –Group III, no heart failure, normal PH and normal PVR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will study a cohort of patients that will be recruited from the cath lab during diagnositic heart catheterization
Key inclusion criteria (4 listed)
- Age >18 years
- Ability to provide informed consent.
- Presenting for cardiac catheterization for evaluation of heart disease
- Ejection Fraction > 50%
Key exclusion criteria (13 listed)
- Unable to provide informed consent.
- Unable or unwilling to comply with the protocol and follow up.
- Infiltrative cardiomyopathy
- Constrictive pericarditis
- Severe valvular disease
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
Mortality
Time frame: 1 year
Checking vital statistics on each patient at one year
1 secondary outcome
Morbidity
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
Related trials for Diastolic Heart Failure
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
RecruitingPhase 1
A Study of LY3971297 in Participants With Heart Failure
Heart Failure, Heart Failure, Diastolic
Not yet recruiting
Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
Valvular Heart Disease Patients, Aortic Stenosis
Recruiting
PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
Heart Failure and Preserved Ejection Fraction, Heart Failure New York Heart Association Class III
Recruiting
Assessment of CCM in HF With Higher Ejection Fraction
Heart Failure, Heart Failure With Preserved Ejection Fraction
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.
Samer Khouri, MD principal investigator
University of Toledo Health Science Campus
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 Diastolic Heart Failure and Pulmonary Hypertension, run by University of Toledo Health Science Campus 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 13 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: finished, as of the sponsor's last update on 18 Sep 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mortality (time frame: 1 year). 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 18 Sep 2019.