Sildenafil in US Heart Failure Patients (SilHF-US)

Status unconfirmed · Phase 3 · Has a placebo group

Conditions studied: Heart Failure, Pulmonary Hypertension

In brief

This protocol describes a 2-arm randomized controlled pilot study assessing the tolerance, safety and efficacy of sildenafil compared to control. The hypothesis is that sildenafil will be well tolerated and efficacious in patients with chronic heart failure (NYHA class II and III) with evidence of systolic dysfunction (EF ≤40 %) and secondary pulmonary hypertension (SPAP \>40mmHg). Patients that satisfy the inclusion criteria will be randomized to sildenafil (40mg x 3) or placebo therapy for 6 months in a 2:1 blinded fashion. The placebo group will be compared to the active therapy group and analyzed for differences in the main study end-points Patient Global Assessment and 6-Minute Walk Test. The study will also assess safety, tolerability, symptoms and quality of life.

Key facts

Study ID

NCT03460470

Run by

Hartford Hospital

People needed

25

Starts

2018-02-14

Expected to finish

2018-12-01

Last updated by the study team

2018-03-09

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women
• 18 - 80 years of age.
• Outpatients with chronic HF. NYHA class II-III on optimal treatment in sinus rhythm or atrial fibrillation
• LVEF ≤ 40% measured during the past 12 months
• SPAP ≥ 40mmHg using echocardiography
• 6MWTD < 475 meters
• NT-pro BNP ≥ 400 pg/ml or BNP ≥100 pg/ml, measured during the past 12 months
• Receiving optimal therapy, including diuretic, ACE-inhibitor, ARB, beta-blocker and aldosterone antagonist. Doses of all medication should be unchanged during the last 30 days before inclusion.
• ICDs and CRTs (CRT-P, CRT-D) are permitted. Implantation should have been performed at > 3 months before inclusion to the trial.
• Exclusion Criteria: -
• Acute Coronary Syndrome, including myocardial infarction, or coronary angiography, with or without intervention, within the last 3 months
• Stroke within the last 3 months
• Planned coronary angiography or planned device-implantation
• Moderate to severe obstructive valve disease
• Documented episodes of sustained ventricular tachycardia
• Prior (past 30 days before the baseline visit) or ongoing use of oral nitrate therapy.
• Concomitant disease which interfere with assessment of dyspnea , severe COPD, asthma, restrictive lung disease, severe obesity
• Anemia (hemoglobin < 10g/dL)
• Uncontrolled hypertension ( SBP >160 mmHg and / or DBP > 90 mmHg)
• Symptomatic or orthostatic hypotension or systolic blood pressure < 90 mmHg
• Clinically important renal dysfunction (GFR < 40m ml/min)
• Women with child-bearing potential
• Prior (past 30 days before the baseline visit) or ongoing use of i) alpha-1 antagonist: doxazosin ii) CYP3A4 inhibitors: erytromycin, ritonavir, sakinovir, itrakonazole, ketokonazole iii) CYP3A4-inducers: rifampicin iv) Any calcium channel blockers
• V) Pulmonary vasodilators at the treatment dose level for Pulmonary hypertensionRetinitis pigmentosa, previous diagnosis of NAION (non-arteritic ischemic opticus-neuropathy), unexplained visual disturbance.
• Sickle cell anemia, multiple myeloma, leukemia or penile anatomic deformities (angulation, cavernosal fibrosis, Peyronie's disease) that increases the risk of priapism.

Where it is running

• Hartford Hospital 80 Seymour street — Hartford, Connecticut, United States (enrolling)

Full record on ClinicalTrials.gov

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