Sildenafil Versus Placebo in Chronic Heart Failure

NCT01616381 | Unknown Phase 3 DMC

• 2 other identifiers: SUS2011DIKE012011-002829-21
• Study Type: interventional
• Target: 75
• Locations: 4 countries
• Sites: 6

Brief Summary

This protocol describes a 2-arm randomised 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 analysed 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.

Conditions

Heart Failure; Pulmonary Hypertension

Outcome Measures

Primary Outcomes (2)

• Patient Global Assessment

  Analysis of change from baseline.

  Baseline, 8 weeks, 24 weeks

• Six minute walk test

  Analysis of change from baseline.

  Baseline, 8 weeks, 24 weeks

Secondary Outcomes (3)

• Quality of Life (QoL) evaluation by EuroQol5D

  Baseline, 8 weeks and 24 weeks

• Kansas City Questionaire

  Baseline, 8 weeks and 24 weeks

• New York Heart Association (NYHA) function class

  Baseline, 8 weeks, 16 weeks and 24 weeks

Study Arms (2)

Sildenafil

ACTIVE COMPARATOR

Sildenafil tablets 40 mg x 3 daily

Drug: Sildenafil

Placebo

PLACEBO COMPARATOR

Placebo tablet x 3 daily

Drug: Placebo

Interventions

Sildenafil DRUG

PDE-5 Inhibitor

Also known as: Revatio

Sildenafil

Placebo DRUG

Placebo for sildenafil 40mg x 3 daily

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women
• 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
• MWTD \< 400 meters
• NT-pro BNP \> 400 pg/ml or BNP \>100 pg/ml, measured during the past 12 months

You may not qualify if:

• 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
• Oral nitrate therapy or frequent use of sublingual nitrate
• Concomitant disease which interfere with assessment of dyspnoea , 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
• Use of
• i) alpha-1 antagonist: doxazosin
• ii) CYP3A4 inhibitors: erytromycin, ritonavir, sakinovir, itraconazole, ketoconazole

Sponsors & Collaborators

• Helse Stavanger HF: lead
• Pfizer: collaborator

Study Sites (6)

Lady Davis Carmel Medical CEnter

Haifa, 34362, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

San Donato Hospital

Milan, 20097, Italy

Location

Stavanger University Hospital

Stavanger, Rogaland, 4011, Norway

Location

Castle Hill Hospital

Hull, HU16 5JQ, United Kingdom

Location

Northern General Hospital

Sheffield, S5 7AU, United Kingdom

Location

Related Publications (1)

• Cooper TJ, Guazzi M, Al-Mohammad A, Amir O, Bengal T, Cleland JG, Dickstein K. Sildenafil in Heart failure (SilHF). An investigator-initiated multinational randomized controlled clinical trial: rationale and design. Eur J Heart Fail. 2013 Jan;15(1):119-22. doi: 10.1093/eurjhf/hfs152. Epub 2012 Oct 24.

  PMID: 23097067 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Hypertension, Pulmonary

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Kenneth Dickstein, MD, PhD

  Helse Stavanger HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2012
• First Posted: June 11, 2012
• Study Start: March 1, 2013
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2019
• Last Updated: May 7, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1); IT (1); IL (2); GB (2)