Heart failure with preserved ejection fraction. MedDRA version: 14.1 Level: LLT Classification code 10069211 Term: Diastolic heart failure System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Revatio 20 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: SILDENAFIL CITRATE
CAS Number: 171599-83-0
Other descriptive name: SILDENAFIL CITRATE
Concentration unit: mg mill
Sponsors
Francisco J. González Vílchez
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age > 18 years. 2. Previous diagnosis of heart failure by any of the following: - Criteria of Framingham. - Hospitalization for decompensated heart failure. - Long-term treatment with a loop diuretic and chronic diastolic dysfunction (left atrial enlargement by echocardiography). 3. Current symptoms with functional class (NYHA) II-IV. 4. Left ventricular ejection fraction > 50% by echocardiography whinthin the previous 3 months before study entry. 5. Receiving stable medical therapy in the 30 days before study entry, as determined by no addition or removal of angiotensin converting enzyme inhibitor (ACE), angiotensin receptor blocker (ARB), beta-blockers, or calcium channel blockers (CCB) and no change in dosage of ACE, ARBs, beta-blockers, or CCBs of more than 100%. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: 1. Has a non-cardiac condition that prevents the subject from exercise testing or from walking in a hallway. 2. Non-cardiac life expectancy 35 Kg/m2] or lung disease requiring oxygen or esteroids or FEV1 20). 7. Resting blood pressure 180 /100. 8. Resting heart rate > 100 bpm. 9. History of ejection fraction 3 times the normal limit, alkaline phosphatase or bilirubin > 2 times the normal limit). 11. Pregnant or not using an effective form of contraception. 12. Taking nitrates, alpha antagonists, cytochrome P450 3A4 inhibitors/inducers, nicorandil, ranolazine or molsidain. 13. Retinitis pigmentosa, previous diagnosis of nonischemic optic neuropathy, untreated proliferative retinopathy, or unexplained visual disturbance. 14. Sickle cell anemia, multiple myeloma, leukemia, or penile deformities that increase the risk for priapism (e.g., angulation, cavernosal fibrosis, Peyronie's disease). 15. Severe cardiac ischemia in scintigraphy or echocardiography. 16. Primary pulmonary arteriopathy. 17. Inability or unwillingness of individual to give written informed consent. 18. Participation in a clinical trial within the 6 months prior to the present study. 19. History of allergy or intolerance to Sildenafil or other 5-Phosphodiesterase inhibitor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate an increase in the total distance walked in the six-minute walk test after 12 weeks of treatment with Sildenafil in patients with HFpEF.;Secondary Objective: 1. To investigate the effect of prolonged oral therapy with Sildenafil on echocardiographic-derived parameters of cardiovascular function at rest and at exercise (cardiovascular reserve): a) Pulmonary artery pressure at rest and at exercise. b) Right ventricle function at rest and at exercise. c) Left ventricle systolic and diastolic function at rest and at exercise. d) Ventricular-vascular coupling at rest and at exercise. 2. To correlate the increase in the total distance walked in the six-minute walk test and the changes in echocardiographic-derived parameters of cardiovascular function. 3. To assess the effect of prolonged oral therapy with Sildenafil on the quality of life in patients with HFpEF, assessed by the score of the Minnesota Living with Heart Failure Questionnaire.;Primary end point(s): To demonstrate an increase in the total distance walked in the six-minute walk test after 12 weeks of treatment with Sildenafil in patients with HFpEF.;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. To investigate the effect of prolonged oral therapy with Sildenafil on echocardiographic-derived parameters of cardiovascular function at rest and at exercise (cardiovascular reserve): a) Pulmonary artery pressure at rest and at exercise. b) Right ventricle function at rest and at exercise. c) Left ventricle systolic and diastolic function at rest and at exercise. d) Ventricular-vascular coupling at rest and at exercise. 2. To correlate the increase in the total distance walked in the six-minute walk test and the changes in echocardiographic-derived parameters of cardiovascular function. 3. To assess the effect of prolonged oral therapy with Sildenafil on the quality of life in patients with HFpEF, assessed by the score of the Minnesota Living with Heart Failure Questionnaire.;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Countries
Spain
Contacts
Public ContactUCICEC H. U. Marqués de Valdecilla
CAIBER (Consorcio de Apoyo a la Investigación Biómédica en Red)
Outcome results
None listed