NCT02304705

Brief Summary

The purpose of this study is to determine whether Sildenafil 20mg taken three times a day is effective in the treatment of Heart Failure with Reactive Pulmonary Hypertension. This is a double-blind, placebo controlled trial.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 2, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

March 13, 2019

Completed
Last Updated

November 7, 2019

Status Verified

October 1, 2019

Enrollment Period

2.4 years

First QC Date

November 26, 2014

Results QC Date

November 20, 2018

Last Update Submit

October 23, 2019

Conditions

Heart Failure With Reactive Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change in Exercise Tolerance

    In a controlled laboratory environment, participants will be asked to walk on a treadmill as fast as they can for 6 minutes. The test will be conducted at baseline and after 90 days of treatment. Data will be presented as the change in distance (in feet) walked in 6 minutes between baseline and treatment.

    Baseline and 90 days

Other Outcomes (4)

  • Change in Right Ventricular Function

    Baseline and 90 day

  • Change in Cardiac Output Relative to Body Surface Area (Cardiac Index)

    Baseline and 90 days

  • Change in Pulmonary Vascular Resistance

    Baseline and 90 days

  • +1 more other outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo three times per day, orally

Drug: Placebo

Sildenafil

ACTIVE COMPARATOR

Sildenafil 20 mg three times per day, orally

Drug: Sildenafil

Interventions

SildenafilDRUG

20 mg three times daily by mouth for 90 days

Also known as: Viagra
Sildenafil
PlaceboDRUG

One capsule three times daily by mouth for 90 days

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Known chronic heart failure appropriately treated with Angiotensin converting enzyme (ACE) inhibitors and beta blockers, unless contraindicated or poorly tolerated
  • indication for right heart catheterization
  • pulmonary artery mean pressure \>25 mmHg
  • pulmonary capillary wedge pressure \> 15 mmHg
  • pulmonary vascular resistance \> 3 Wood units

You may not qualify if:

  • hypersensitivity, allergy, or intolerable side effect to sildenafil
  • history of primary pulmonary hypertension, connective tissue disorder, severe chronic obstructive pulmonary disorder (COPD), pulmonary embolism, or left to right shunt
  • co-morbidities, limited exercise intolerance:
  • morbid obesity (BMI \>40)
  • COPD with oxygen dependence
  • severe peripheral vascular disease with intermittent claudication
  • status post amputation of lower extremity at any level
  • severe degenerative joint disease preventing normal walking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

Related Publications (1)

  • Guglin M, Rajagopalan N, Anaya P, Charnigo R. Sildenafil in heart failure with reactive pulmonary hypertension (Sildenafil HF) clinical trial (rationale and design). Pulm Circ. 2016 Jun;6(2):161-7. doi: 10.1086/685548.

    PMID: 27252841DERIVED

MeSH Terms

Interventions

Sildenafil Citrate

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Limitations and Caveats

There is a real risk that individuals presenting to the cardiology clinics will choose not to participate based on the physical exertion requirement.

Results Point of Contact

Title
Dr. Maya Guglin
Organization
University of Kentucky
maya.guglin@uky.edu
859-323-4738

Study Officials

  • Maya E Guglin, MD, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Clinical Faculty

Study Record Dates

First Submitted

November 26, 2014

First Posted

December 2, 2014

Study Start

January 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

November 7, 2019

Results First Posted

March 13, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)