Clinical trial NCT02620995: Effects of Sildenafil on Penile Vascular Function in Hypertensive Men With Erectile Dysfunction
Official title: Evaluation of Systemic and Penile Microvascular Endothelial Function and Arterial Pressure After Chronic Administration of Sildenafil in Hypertensive Men With Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arterial Hypertension
Erectile Dysfunction
Keywords: hypertension
endothelial dysfunction
erectile dysfunction
sildenafil
Lead sponsor: National Institute of Cardiology, Laranjeiras, Brazil
Sponsor class: OTHER_GOV
First posted: 2015-12-03
Enrollment: 50
Sex: MALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study will evaluate the effects of a chronic 30-day treatment with sildenafil citrate on penile and systemic microvascular function as well as in blood pressure.

A control group of normotensive age-matched healthy subjects will serve as a comparator group for normal penile and systemic microvascular function.

Detailed description: Vasculogenic erectile dysfunction (ED) is a highly prevalent health problem that is directly related with increased cardiovascular risk. In this context, phosphodiesterase type 5 inhibitors (PDE5 inhibitors) are indicated in the treatment of ED because these drugs increase bioavailability of the endothelial-dependent potent vasodilator nitric oxide. Thus, these drugs could also induce a reduction in arterial pressure and improve microvascular endothelial function in hypertensive patients.

The primary aim of the study is to investigate the acute and chronic effects of sildenafil citrate (®Viagra) on penile and systemic microvascular function of hypertensive patients presenting with ED. The secondary aim is to evaluate the effects of the treatment on arterial pressure.

The study design is a prospective 2 x 2 cross-over, randomized, double blind clinical trial that will include 75 sexually active hypertensive men (age between 50-70 years) under anti-hypertensive treatment (arterial pressure \< 160/100 mmHg) presenting with ED. Erectile function will be evaluated using the International Index of Erectile Function (IIEF-5) questionnaire. Patients with non-vasculogenic ED or diabetes will be excluded from the study. Forty-five age-matched healthy subjects will be included as a comparator group.

The evaluation of systemic microvascular function will be performed in the skin of the forearm and penile microvascular function in the skin of the base of the penis using the non-invasive methodology of laser speckle flowmetry coupled to cutaneous iontophoresis of a vasodilator (acetylcholine).

In the acute protocol, microvascular evaluation will be carried out before and one hour after the oral administration of 100 mg of sildenafil citrate. In the chronic protocol, only hypertensive men will be randomized to receive either or placebo sildenafil 50 mg twice daily for 30 days. After a 30-day washout period the patients will receive the complementary treatment.

The evaluation of penile and systemic microvascular function, as well as ambulatory blood pressure monitoring, will be performed before randomization and in the end of each treatment period.

Eligibility criteria: Inclusion Criteria:

* arterial hypertension stage I or II
* erectile dysfunction (vasculogenic)

Exclusion Criteria:

* diabetes
* kidney, liver, neurologic and psychiatric diseases

Primary outcomes:
measure: Penile microvascular vasodilatory capacity
timeFrame: at the end of a 30-day treatment
Secondary outcomes:
measure: Blood pressure levels evaluated using ambulatory blood pressure monitoring
timeFrame: at the end of a 30-day treatment
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: National Institute of Cardiology, Ministry of Health, Brazil
Study officials:
affiliation: National Institute of Cardiology - Ministry of Health -Brazil
name: Eduardo V Tibirica, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: