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Tadalafil Effects in Left Ventricle Diastolic Dysfunction in Resistant Hypertensive Patients

NCT ID: NCT01743911

Last Updated: 2012-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-08-31

Brief Summary

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Left ventricle diastolic dysfunction (LVDD) is associated with resistant hypertension. In addition, brain natriuretic peptide (BNP) levels are elevated when LVDD is present. It has been shown that phosphodiesterase-5 (PDE5) inhibition improves left ventricle diastolic function in hypertensive rats, despite any difference in blood pressure levels. Also, left ventricle diastolic function enhancement reduces BNP concentration in hypertensive patients. However, it is unknown if these effects exists in humans with resistant hypertension. Therefore, this study was developed to evaluate if the use of a PDE5 inhibitor (tadalafil) for 2 weeks improves LVDD and its effects in BNP levels in resistant hypertensive patients.

Detailed Description

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Resistant hypertensive patients have a high incidence of left ventricle diastolic dysfunction (LVDD). Lowering blood pressure levels improves diastolic function, however, there is no proved effective treatment specifically for this disease. Studies in hypertensive rats have shown presence of phosphodiesterase-5 in cardiac cells and an improvement in left ventricle diastolic function using a phosphodiesterase-5 (PDE5) inhibitor, the sildenafil. PDE5 has also been demonstrated in human heart cells with cardiac disease. In addition, LVDD is associated with high levels of brain natriuretic peptide (BNP), which reduces with diastolic function improvement. Therefore, it is reasonable to suppose that PDE-5 inhibitor use in humans with LVDD and resistant hypertension could improve diastolic function. Objective: Evaluate the chronic effect of a PDE-5 inhibitor on LVDD and BNP levels in resistant hypertensive patients. Casuistic and methods: 20 resistant hypertensive patients with LVDD types I and II will be evaluated with echocardiography study, ambulatory blood pressure monitoring (ABPM), office blood pressure measurements, endothelial function analysis using the brachial artery flow mediation dilation technique (FMD) and BNP plasma levels. Then, the subjects will receive oral placebo for 2 weeks. After this period, the same exams will be repeated. Two weeks later, the protocol will be performed again to the same 20 patients, using tadalafil (the longest half-life PDE-5 inhibitor) 20mg orally instead of the placebo. Hypothesis: investigators hypothesize that the use of tadalafil will improve left ventricle diastolic function with BNP reduced levels and this effect will be independent of blood pressure decrease or endothelial function improvement.

Conditions

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Hypertension

Keywords

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Tadalafil Resistant Hypertension Left Ventricle Diastolic Dysfunction Brain natriuretic peptide

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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sugar pill

Intervention: sugar pill

Group Type PLACEBO_COMPARATOR

sugar pill

Intervention Type OTHER

Sugar pills: 20mg orally, once a day for 2 weeks

tadalafil

Intervention: tadalafil

Group Type ACTIVE_COMPARATOR

Tadalafil

Intervention Type DRUG

Tadalafil pills: 20mg orally, once a day for 2 weeks.

Interventions

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sugar pill

Sugar pills: 20mg orally, once a day for 2 weeks

Intervention Type OTHER

Tadalafil

Tadalafil pills: 20mg orally, once a day for 2 weeks.

Intervention Type DRUG

Other Intervention Names

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No brand name. Cialis, Lilly, USA

Eligibility Criteria

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Inclusion Criteria

* resistant hypertension (according to Resistant Hypertension - American Heart Association Statement - 2008);
* compliance with antihypertensive treatment;
* age \>35 years;
* left ventricle diastolic dysfunction types I and II

Exclusion Criteria

* valvulopathy
* decompensated heart failure
* important cardiac arrhythmias
* nephropathy
* hepatopathy
* autoimmune disease
* tabagism
* decompensated diabetes
* uncontrolled dislipidemia
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Campinas, Brazil

OTHER

Sponsor Role lead

Responsible Party

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Heitor Moreno Junior

MD, PhD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heitor Moreno-Junior, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medical Sciences - Unicamp

Locations

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Laboratory of Cardiovascular Pharmacology - FCM - Unicamp

Campinas, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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[2009/53430-7]

Identifier Type: OTHER

Identifier Source: secondary_id

CAAE 0044.0.146.000-09

Identifier Type: -

Identifier Source: org_study_id