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Sildenafil Versus Placebo in Chronic Heart Failure

NCT01616381 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2018-05-07

No results posted yet for this study

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

Interventions

DRUG

Sildenafil

PDE-5 Inhibitor

DRUG

Placebo

Placebo for sildenafil 40mg x 3 daily

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Helse Stavanger HF

    lead OTHER_GOV

Principal Investigators

  • Kenneth Dickstein, MD, PhD · Helse Stavanger HF

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2018-06-30
Completion
2019-12-31

Countries

  • Israel
  • Italy
  • Norway
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01616381 on ClinicalTrials.gov