Evaluation of Sildenafil for the Treatment of Moderate Congestive Heart Failure

NCT00793338 | Withdrawn Phase 4 DMC

• 1 other identifier: HRRC 05-369
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate whether sildenafil helps treat heart failure. Some patients with heart failure have high blood pressure in the lungs (referred to as "pulmonary hypertension"). Sildenafil is a medication that is used to treat high blood pressure in the lungs and may reduce symptoms of heart failure. Studies have looked at the short-term benefit of sildenafil in patients with congestive heart failure, but this study will look at the longer-term benefits of 12 weeks of therapy with sildenafil.

Conditions

Heart Failure

Keywords

Heart failure; Sildenafil; Cardiopulmonary exercise test; quality of life; 6 minute walk test

Outcome Measures

Primary Outcomes (1)

• Change in 6-minute walk distance

  24 hours and 3 months

Secondary Outcomes (3)

• Changes in peak oxygen consumption (measured by cardiopulmonary exercise testing)

  24 hours and 3 months

• Change in the level of neurohormones (b-type natriuretic peptide, catecholamines, ET-1),

  24 hours and 3 months

• Change in quality of life

  3 months

Study Arms (1)

Sildenafil

EXPERIMENTAL

All patients will receive open-label treatment with sildenafil.

Drug: Sildenafil

Interventions

Sildenafil DRUG

Sildenafil 20mg three times a day for 3 months.

Also known as: Heart failure, Cardiopulmonary exercise test

Sildenafil

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18 years
• Diagnosis of chronic heart failure with an ejection fraction less than or equal to 45% per either an echocardiogram, nuclear cardiolyte stress test, or cardiac catheterization performed within the past 6 months.
• New York Heart Association Functional Class III
• Must be on optimal heart failure therapy according to AHA/ACC heart failure guidelines, including treatment with ACEI and beta-blocker therapy, or have documented rationale for variation, including intolerance, contraindication, patient preference, or personal physician's judgment

You may not qualify if:

• Comorbid disease or behavioral or other limitations that: 1) interfere with performing exercise test, or 2) prevent completion of 12 week study
• Currently pregnant or intent to become pregnant in the next 12 weeks or currently breastfeeding.
• Major cardiovascular event or cardiovascular procedure within the prior 6 weeks
• History of Chronic Obstructive Pulmonary Disease or Reactive Airway Disease
• Known hypersensitivity to sildenafil
• Current use of medications known to be a potent inhibitor of CYP3A4 (e.g., ritonavir, ketoconazole, itraconazole)
• Current or recent (within 6 months) use of organic nitrate medications (e.g. isosorbide dinitrate, sublingual nitroglycerin)
• Known diagnosis of pulmonary veno-occlusive disease or non-arteritic anterior ischemic optic neuropathy

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

Clinical Translational Science Center

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Sildenafil Citrate; Exercise Test

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular 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; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Joe R Anderson, PharmD

  University of New Mexico College of Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pharmacy Practice and Administrative Sciences

Study Record Dates

• First Submitted: November 17, 2008
• First Posted: November 19, 2008
• Study Start: November 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: February 1, 2011
• Last Updated: June 26, 2023

Record last verified: 2023-06

Locations

US (1)