NCT01156636

Brief Summary

Prevalence of heart failure (HF) with left ventricular (LV) diastolic dysfunction and preserved ejection fraction (EF) (HFpEF) is increasing. Prognosis worsens with development of pulmonary vasoconstriction and hypertension (PH) and right ventricular (RV) failure. The investigators aimed at modulating pulmonary vascular tone and RV burden in HFpEF due to high blood pressure (HBP), by using the phosphodiesterase-5 (PDE5) inhibitor sildenafil.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2006

Typical duration for phase_2

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 5, 2010

Completed
Last Updated

June 15, 2012

Status Verified

June 1, 2009

Enrollment Period

3.7 years

First QC Date

July 2, 2010

Last Update Submit

June 14, 2012

Conditions

Pulmonary HypertensionDiastolic Heart Failure

Keywords

Diastolic Heart FailurePulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

  • Pulmonary hemodynamics

    1 year

Study Arms (2)

Sildenafil

ACTIVE COMPARATOR
Drug: Sildenafil

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

SildenafilDRUG

50 mg 3 times/day for 1 year

Sildenafil
PlaceboDRUG
Placebo

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • LVEF \>50%
  • sinus rhythm and stable clinical condition defined as no changes in therapeutic regimen, or hospitalization in the 6 months preceding recruitment.
  • pulmonary artery systolic pressure \> 40 mm Hg,

You may not qualify if:

  • Patients receiving nitrates
  • A history of pulmonary disease
  • Alternative causes of PH other than cardiac-related
  • Renal failure (creatinine \> 2mg/dL)
  • Anemia
  • Pericardial disease
  • Cardiac amyloidosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Guazzi M, Vicenzi M, Arena R, Guazzi MD. Pulmonary hypertension in heart failure with preserved ejection fraction: a target of phosphodiesterase-5 inhibition in a 1-year study. Circulation. 2011 Jul 12;124(2):164-74. doi: 10.1161/CIRCULATIONAHA.110.983866. Epub 2011 Jun 27.

    PMID: 21709061DERIVED

MeSH Terms

Conditions

Hypertension, PulmonaryHeart Failure, Diastolic

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesHeart FailureHeart Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 2, 2010

First Posted

July 5, 2010

Study Start

January 1, 2006

Primary Completion

September 1, 2009

Study Completion

December 1, 2009

Last Updated

June 15, 2012

Record last verified: 2009-06