Tadalafil Effects in Left Ventricle Diastolic Dysfunction in Resistant Hypertensive Patients

NCT01743911 | Completed

• 2 other identifiers: CAAE 0044.0.146.000-09[2009/53430-7]
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Keywords

Tadalafil; Resistant Hypertension; Left Ventricle Diastolic Dysfunction; Brain natriuretic peptide

Outcome Measures

Primary Outcomes (1)

• Change in Left Ventricle Diastolic Dysfunction

  Outcome measurement assessed by Echocardiogram before and after a 2-week tadalafil administration period.

  Baseline and 2 weeks

Secondary Outcomes (5)

• Change in endothelial function

  baseline and 2 weeks

• Change in blood pressure levels

  Baseline and 2 weeks

• Change in B-type Natriuretic Peptide (BNP-32) levels

  Baseline and 2 weeks

• Change in cyclic guanosine monophosphate (cGMP) levels

  Baseline and 2 weeks

• Change in nitrite levels

  Baseline and 2 weeks

Study Arms (2)

sugar pill

PLACEBO COMPARATOR

Intervention: sugar pill

Other: sugar pill

tadalafil

ACTIVE COMPARATOR

Intervention: tadalafil

Drug: Tadalafil

Interventions

sugar pill OTHER

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

Also known as: No brand name.

sugar pill

Tadalafil DRUG

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

Also known as: Cialis, Lilly, USA

tadalafil

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• valvulopathy
• decompensated heart failure
• important cardiac arrhythmias
• nephropathy
• hepatopathy
• autoimmune disease
• tabagism
• decompensated diabetes
• uncontrolled dislipidemia

Sponsors & Collaborators

• University of Campinas, Brazil: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Laboratory of Cardiovascular Pharmacology - FCM - Unicamp

Campinas, São Paulo, 13083-970, Brazil

Location

MeSH Terms

Conditions

Hypertension

Interventions

Sugars; Tadalafil

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates; Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Heitor Moreno-Junior, MD, PhD

  Faculty of Medical Sciences - Unicamp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD.

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: December 6, 2012
• Study Start: September 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: August 1, 2012
• Last Updated: December 6, 2012

Record last verified: 2012-12

Locations

BR (1)