Status:
COMPLETED
Association Between Coronary Flow Reserve and BH4 Levels in High CV Risk
Lead Sponsor:
IRCCS San Raffaele
Collaborating Sponsors:
Servier
Conditions:
Hypertension,Essential
Eligibility:
All Genders
18-80 years
Brief 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 .
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 param...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
June 6 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 10 2019
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03841383
Start Date
June 6 2017
End Date
July 10 2019
Last Update
July 12 2019
Active Locations (2)
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1
ASST Papa Giovanni XXIII
Bergamo, Italy, 24127
2
IRCCS Ospedale San Raffaele
Milan, Italy, 20132