Hypertension,EssentialNCT03841383
Association Between Coronary Flow Reserve and BH4 Levels in High CV Risk
An observational study of Hypertension,Essential, run by IRCCS San Raffaele at 2 sites in Italy.
Trial summary
To determine if there is a relationship between coronary flow reserve (CFR) and platelet/plasma BH2 and BH4 levels in patients with high cardiovascular risk . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension,Essential
- What is being tested?
- Echo stress dipyridamole
- How many people
- 55 participants
- Where
- 2 sitesItaly
- Study dates
- 6 Jun 2017to 10 Jul 2019
- 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 80 years
- All sexes
- Adult, Older adult
Study population: Symptomatic (angina symptoms both typical and atypical ) patients referred to the hospital with hypertension plus risk factors: diabetes, hypercholesterolemia, smoking, chronic renal failure
Who may be able to join
- o men and women (females of childbearing potential must be using highly effective contraceptive precautions such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence or vasectomised partner)
- Females of childbearing potential or within two years from the menopause must have a negative urine pregnancy test
- between 40 and 80 years of age
- documented history of hypertension
- smokers/non smokers R
- type 2 diabetes R
Show all 11Show fewer
- Moderate to severe kidney disease (GFR >30 and <60 ml/min/1.73m2 (estimated MDRD) R
- Hypercholesterolemia R
- Receiving an optimal standard antihypertensive treatment for at least 6 months, stable for at least 15 days
- All other concomitant treatments stabilized at least for the preceding 15 days
- Able to give written informed consent
Who cannot join
- o Females of childbearing potential not using highly effective contraceptive precautions
- Patients with obstructive (>50% diameter reduction) CAD on the LAD (based on invasive angiography or coronary CTA) or with evidence of previous myocardial infarction or history of revascularization in the LAD territory.
- CAD on the RCA or CX with diameter reduction > 50% (based on invasive angiography or coronary CTA) , either native or revascularized (stent)
- Patients with infectious disease and/or chronic inflammatory diseases
- Epicardial coronary arteries spasm
- Patients with severe valve disease and/or significant left ventricular wall motion abnormalities
Show all 12Show fewer
- Patients under treatment with non-selective beta blockers including propranolol, nadolol, pindolol, labetalol, penbutolol, sotalol, carvedilol, and timolol.
- Contraindications to dipyridamole infusion: asthma, bronchospasm, previous < 24 hours ingestion of phylline derivatives (tea, coffee, cola, xanthines and chocolate) sick sinus syndrome, advanced AV block (second and third degree), systolic blood pressure < 90 mmHg, cerebral ischemia, severe sinus bradycardia (heart rate <40/min), use of dipyridamole during the last 24 h, severe atherosclerotic lesions of extracranial artery >75%.
- Acute treatment or treatment for acute diseases
- Patients receiving steroidal anti-inflammatory drugs, dietary supplements of folic acid, or antioxidant vitamins.
- Any condition that may prevent the pt to give informed consent , enter the study or bias the results.
- Participating into other studies
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
ASST Papa Giovanni XXIII
Bergamo, 24127
IRCCS Ospedale San Raffaele
Milan, 20132
About this study
Official title: Study to Investigate the Association Between Coronary Flow Reserve and BH4 Levels in Patients With High Cardiovascular Risk
To determine if there is a relationship between coronary flow reserve (CFR) and platelet/plasma BH2 and BH4 levels in patients with high cardiovascular risk .
Read the detailed description
Primary parameter :
relationship between coronary flow reserve (CFR) and platelet/plasma BH2 and BH4 levels in patients with hypertension and concomitant cardiovascular risk factors.
Secondary parameter:
Levels of cGMP in platelets.
- Study design
Three parallel groups of patients (n=15 per group):
- Group 1 with normal coronary flow reserve (CFR ≥2.5)
- Group 2 with reduced coronary flow reserve (CFR≤2.0)
- Group 3 control subjects (without a high risk profile according to ESC score chart http://www.heartscore.org. ) matched for age (between 40 and 80 years of age)
- and gender. 1/3 enrolled patients must be diabetic (Type2 diabetes)
- Conditions
- Hypertension,Essential
- Being tested
- Echo stress dipyridamole
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echo stress dipyridamoleDiagnostic test
Also called Blood sample
Echo stress dipyridamole
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Not described Receives: Diagnostic Test: Echo stress dipyridamole | |
| Hypertensive patients | Not described Receives: Diagnostic Test: Echo stress dipyridamole |
What is being measured
The primary outcome is the main question the study is designed to answer.
BH2 and BH4 levels (ng/ml) in plasma and platelets
Blood samples will be withdrawn and subsequently analyzed to assess biopterins BH4 and BH2 ng/mL concentration in plasma and platelets Each will be determined separately from the same sample, by high-performance liquid chromatography followed by serial electrochemical and fluorescent detection.
Measured: 1 week
Coronary Flow Reserve (CFR) Trans Thoracic Doppler Echocardiography
Measurement of coronary flow reserve of the left anterior descending coronary artery will be carried out with transthoracic Doppler Echocardiography (TDE) and dipyridamole stress. CFR will be calculated as the ratio between stress and resting flow velocity (cm/sec)
Measured: 1 week
Relationship between coronary flow reserve (CFR) and platelet/plasma BH2 and BH4 levels.
Simple regression analysis or logistic regression will be used to test the relationship between CFR and biopterins values in plasma and platelets.
Measured: 1 week
Secondary outcomes (1)
Levels of cGMP in platelets
Comparison of levels of cGMP in platelets among normals, patients with normal CFR and patients with reduced CFR
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start6 Jun 2017
- Primary completion31 May 2019
- Study completion10 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension,EssentialStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Servier
- Responsible party
- Principal investigator, Prof. Paolo G Camici MD FACC, IRCCS San Raffaele
- Investigators
- Paolo G Camici, MD, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841383
- Sponsor's protocol ID
- CFRBH4_IT1
- Status last verified
- Jul 2019
- First submitted
- 25 Jan 2019
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- 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 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Investigate the Association Between Coronary Flow Reserve and BH4 Levels in Patients With High Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT03841383
- Acronym / sponsor ID
- CFRBH4_IT1
- Conditions
- Hypertension,Essential
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Servier
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 15 Feb 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.
To determine if there is a relationship between coronary flow reserve (CFR) and platelet/plasma BH2 and BH4 levels in patients with high cardiovascular risk .
Detailed description
Primary parameter :
relationship between coronary flow reserve (CFR) and platelet/plasma BH2 and BH4 levels in patients with hypertension and concomitant cardiovascular risk factors.
Secondary parameter:
Levels of cGMP in platelets.
- Study design
Three parallel groups of patients (n=15 per group):
- Group 1 with normal coronary flow reserve (CFR ≥2.5)
- Group 2 with reduced coronary flow reserve (CFR≤2.0)
- Group 3 control subjects (without a high risk profile according to ESC score chart http://www.heartscore.org. ) matched for age (between 40 and 80 years of age)
- and gender. 1/3 enrolled patients must be diabetic (Type2 diabetes)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | Diagnostic Test: Echo stress dipyridamole |
| Hypertensive patients | – | Diagnostic Test: Echo stress dipyridamole |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Symptomatic (angina symptoms both typical and atypical ) patients referred to the hospital with hypertension plus risk factors: diabetes, hypercholesterolemia, smoking, chronic renal failure
Key inclusion criteria (11 listed)
- o men and women (females of childbearing potential must be using highly effective contraceptive precautions such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence or vasectomised partner)
Key exclusion criteria (12 listed)
- o Females of childbearing potential not using highly effective contraceptive precautions
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 |
|---|---|---|
| Echo stress dipyridamoleAlso: Blood sampleEcho stress dipyridamole | Diagnostic test | Healthy controls, Hypertensive patients |
Primary outcome
BH2 and BH4 levels (ng/ml) in plasma and platelets
Time frame: 1 week
Blood samples will be withdrawn and subsequently analyzed to assess biopterins BH4 and BH2 ng/mL concentration in plasma and platelets Each will be determined separately from the same sample, by high-performance liquid chromatography followed by serial electrochemical and fluorescent detection.
Coronary Flow Reserve (CFR) Trans Thoracic Doppler Echocardiography
Time frame: 1 week
Measurement of coronary flow reserve of the left anterior descending coronary artery will be carried out with transthoracic Doppler Echocardiography (TDE) and dipyridamole stress. CFR will be calculated as the ratio between stress and resting flow velocity (cm/sec)
Relationship between coronary flow reserve (CFR) and platelet/plasma BH2 and BH4 levels.
Time frame: 1 week
Simple regression analysis or logistic regression will be used to test the relationship between CFR and biopterins values in plasma and platelets.
1 secondary outcome
Levels of cGMP in platelets
Time frame: 1 week
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 12 Jul 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Hypertension,Essential
Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
PRIMARY HYPERTENSION
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
Hypertension (HTN), Hypertension
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
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.
Paolo G Camici, MD principal investigator
IRCCS Ospedale San Raffaele
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension,Essential, run by IRCCS San Raffaele at 2 sites in Italy.
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 11 inclusion and 12 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 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
BH2 and BH4 levels (ng/ml) in plasma and platelets (time frame: 1 week). The study lists 3 primary outcomes in all. 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 12 Jul 2019.