Tadalafil Effects in Left Ventricle Diastolic Dysfunction in Resistant Hypertensive Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): sugar pill; Tadalafil
Intervention type(s): Other; Drug
Intervention description(s): Sugar pills: 20mg orally, once a day for 2 weeks; Tadalafil pills: 20mg orally, once a day for 2 weeks.
Other intervention name(s): No brand name.; Cialis, Lilly, USA
Intervention MeSH terms: Tadalafil
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Tadalafil; Resistant Hypertension; Left Ventricle Diastolic Dysfunction; Brain natriuretic peptide