Evaluation of the efficacy of sildenafil on the functional capacity of patients with heart failure with preserved ejection fraction. A randomized, double blind, parallel group and placebo-controlled clinical trial.

Phase 1

• Conditions: Heart failure with preserved ejection fraction.; MedDRA version: 14.1Level: LLTClassification code 10069211Term: Diastolic heart failureSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-001674-25-ES
• Lead Sponsor: Francisco J. González Vílchez

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-28
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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

1. Has a non-cardiac condition that prevents the subject from exercise testing or from walking in a hallway.
2. Non-cardiac life expectancy < 1 year.
3. Current or anticipated future need for nitrate therapy.
4. Any valvular, pericardial o cardiomyopathy with specific therapy requirements.
5. Acute coronary syndrome o coronary revascularization in the previous 6 months or expected need of coronary revascularization in the year after study entry.
6. Any non-cardiac condition known to be associated with dyspnea (morbid obesity [Body mass index > 35 Kg/m2] or lung disease requiring oxygen or esteroids or FEV1 < 50% predicted or Epworth Sleepiness Scale > 20).
7. Resting blood pressure < 110 / 40 mmHg or > 180 /100.
8. Resting heart rate > 100 bpm.
9. History of ejection fraction < 50%.
10. Hb < 10 g/dL, severe renal disease (estimated glomerular filtration rate < 20 ml/min/1.73m2 g) or severe hepatic disease (aspartate aminotransferase level > 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified