Association Between Coronary Flow Reserve and BH4 Levels in High CV Risk

NCT03841383 | Completed

• 1 other identifier: CFRBH4_IT1
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 2

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 .

Conditions

Hypertension,Essential

Outcome Measures

Primary Outcomes (3)

• 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  Blood samples will be withdrawn and subsequently analyzed to assess biopterins BH4 and BH2 ng/mL concentration in plasma and platelets Each will be determined separately from the same sample,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.

  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)

  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.

  1 week

Secondary Outcomes (1)

• Levels of cGMP in platelets

  1 week

Study Arms (2)

Healthy controls

Diagnostic Test: Echo stress dipyridamole

Hypertensive patients

Diagnostic Test: Echo stress dipyridamole

Interventions

Echo stress dipyridamole DIAGNOSTIC_TEST

Echo stress dipyridamole

Also known as: Blood sample

Healthy controls; Hypertensive patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Servier: collaborator

Study Sites (2)

ASST Papa Giovanni XXIII

Bergamo, 24127, Italy

Location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Paolo G Camici, MD

  IRCCS Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: February 15, 2019
• Study Start: June 6, 2017
• Primary Completion: May 31, 2019
• Study Completion: July 10, 2019
• Last Updated: July 12, 2019

Record last verified: 2019-07

Locations

IT (2)