Effect of heart rate reduction on the arterial wall - Impact of aging

Phase 1

• Conditions: Healthy subjects between 25 and 65 years old; MedDRA version: 18.0Level: HLTClassification code 10007574Term: Cardiac imaging proceduresSystem Organ Class: 10022891 - Investigations; MedDRA version: 18.0Level: PTClassification code 10052677Term: Vascular imagingSystem Organ Class: 10022891 - Investigations; MedDRA version: 18.0Level: PTClassification code 10006093Term: BradycardiaSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2015-002060-17-FR
• Lead Sponsor: CHU - Hôpitaux de Rouen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-05
• Last Update Posted: 6 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

•Healthy subject
•Aged between 25 and 65 years old
•Caucasian
•Resting heart rate mesured three times after a rest period of 15 min = 70 bpm
•No significant ECG abnormality
•No significant biological abnormality
•Childbearing age women must have effective contraception (estrogen-progestin contraceptives, intrauterin device or tubal ligation). Will be considered postmenopausal women with amenorrhea for more than 2 years
•Able to read and understand information form and to give written informed consent
•Subjects with medical insurance
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Subjects who don’t understand French language

•Subjects deprived of liberty by an administrative or judicial decision or protected adult subject (under guardianship)

•Pregnant women, nursing mother or women without contraception

•Subjects who participate to an other trial / participated to an other interventional research without drugs during the last month or a trial with drugs during the last 3 months

•Hypersensitivity to the active substance or to any of the excipients

•Congenital galactosemia, lactase deficiency (Lapp), malabsorption of glucose and galactose

•Severe hypotension, mesured three times after a rest period of 15 min (< 90/50 mmHg)

•Essential or secondary hypertension, mesured three times after a rest period of 15 min (SBP =140 mmHg and/or DBP =90 mmHg)

•Smoking at the day of inclusion (>5 cigarettes/day)

•Severe hypercholesterolemia (Total cholesterol >2,5 g/L)

•Subjects who practice sports intensively (= 1 hour/day)

•Renal insufficiency (creatinine clearance = 60 ml/min/1,73 m² Cockroft and Gault formula)

•Known liver failure

•Known heart failure or suspected heart failure (congestive episode)

•Atrial fibrillation

•High-grade conduction block (Sick sinus syndrome, sino-atrial block or grade 2 or 3 atrio-ventricular block)

•Abnormal corrected QT with Bazett formula (cQT > 450 ms (men) or > 470 ms (women)).

•Pacemaker

•All cardiac or no cardiac diseases, active or with sequelae, which, in the opinion of the investigator, is accompanied by a risk of cardiac or vascular abnormality

•Known retinal disease

•Subject disagrees with the prohibition of taking grapefruit juice, millepertuis or any medication during the study except oral contraceptive, acetaminophene or decision of the investigator. (annex n°02)

•Administration of any medication listed in anex n°02 (aspirin, NSAID and inhibitors of cytochrome P450 3A4) during the previous week.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified