Endothelial Dysfunction Clinical Trial
Official title:
Endothelial, Autonomic and Pressure Effects of Paroxetine in Recent Postmenopause Women With Hot Flashes: a Randomized Placebo Controlled Clinical Trial
Hot flashes, vasomotor symptoms that affect many postmenopausal women, are associated with cardiovascular disease and endothelial dysfunction. Estrogen therapy, associated or not with progestogens, is the standard treatment for vasomotor symptoms and improves the endothelial function of postmenopausal women with hot flushes, even those with cardiovascular risk factors, such as hypertension. It is not known whether hot flushes are a cause for the development of endothelial dysfunction or are markers of this dysfunction, evidenced by estrogen deficiency, thus representing primitive target organ (vessel) lesion. Paroxetine was approved by the FDA as a non hormonal treatment for menopausal hot flashes. In this double-blind randomized clinical trial, the vascular effects of paroxetine at a dose of 7.5 mg / day, compared to placebo, during 12 weeks are evaluated.
Paroxetine and placebo effects at baseline and after 12 weeks in endothelial, autonomic and
pressure components of vascular function are evaluated.
Non invasive venous occlusion plethysmography is used to study endothelial function;
ambulatory blood pressure monitoring is used to study blood pressure variations during
daytime and nocturnal descent; autonomic function is studied following sympathetic and
parasympathetic parameters through heart rate variability.
The effects of paroxetine and placebo are also evaluated on:
- daytime sleepiness (through Epworth Sleepiness Scale ),
- sleep quality (through Pittsburgh Sleep Quality Index),
- perceived stress (through Perceived Scale Stress).
Biochemical and hormonal profiles including complete lipid profile, fasting glucose, insulin,
estradiol, follicle stimulating hormone (FSH), luteinizing hormone (LH); inflammatory and
oxidative stress markers are also studied.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02122198 -
Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women
|
N/A | |
| Completed |
NCT04156711 -
Remote Ischemic Preconditioning in Patients Undergoing Acute Minor Abdominal Surgery
|
N/A | |
| Recruiting |
NCT06133634 -
Fisetin to Improve Vascular Function in Older Adults
|
Phase 1/Phase 2 | |
| Completed |
NCT05872139 -
Role of Mitochondrial-derived Oxidative Stress to Promote Vascular Endothelial Dysfunction in Non-exercisers With Aging
|
N/A | |
| Recruiting |
NCT04558450 -
Covid-19 Effects on Arterial Stiffness and Vascular Aging (CARTESIAN)
|
N/A | |
| Terminated |
NCT03325933 -
Resistance Training and Cardiometabolic Health
|
N/A | |
| Not yet recruiting |
NCT05939934 -
Impact of the Mandibular Advancement Device on Sleep Apnea During CPAP Withdrawal
|
N/A | |
| Completed |
NCT02652975 -
Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium
|
N/A | |
| Recruiting |
NCT02334839 -
The Association Between Severity of Hypertensive Disorder During Pregnancy and Endothelial Dysfunction
|
N/A | |
| Recruiting |
NCT02020044 -
Outcome After Descemet Membrane Endothelial Keratoplasty (DMEK) and Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
|
N/A | |
| Completed |
NCT01775865 -
Targeting Inflammation to Treat Cardiovascular Aging
|
Phase 2 | |
| Completed |
NCT01691404 -
Study on the Effects of Epicatechin and Quercetin Supplementation on Vascular Function and Blood Pressure (FLAVO)
|
N/A | |
| Terminated |
NCT01412216 -
The Effects of Sedentarism on Vascular Function, Inflammation, and Insulin Resistance
|
Phase 2 | |
| Completed |
NCT01319344 -
Effect of Eplerenone on Endothelial Function in Metabolic Syndrome
|
Phase 3 | |
| Completed |
NCT00990730 -
Atherosclerosis in Rheumatoid Arthritis
|
N/A | |
| Completed |
NCT00848302 -
Endothelial Function in Human Arteries
|
Early Phase 1 | |
| Completed |
NCT00987974 -
Short Term Statin Treatment and Endothelial Dysfunction Due to Ischemia and Reperfusion Injury
|
Phase 4 | |
| Completed |
NCT00532844 -
A Phase 2, Pharmacokinetic (PK) Study of 6R-BH4 Alone or 6R-BH4 With Vitamin C in Subjects With Endothelial Dysfunction
|
Phase 2 | |
| Completed |
NCT00376246 -
Effect of Ezetimibe on Flow-mediated Brachial Artery Reactivity in Healthy Subjects
|
Phase 4 | |
| Completed |
NCT00775099 -
Combustion Derived Air Pollution and Vascular Function
|
N/A |