Brief Summary

The purpose of this study is to evaluate the clinical efficacy of the mid-term treatment with sildenafil in patients with persistent moderate or severe pulmonary hypertension (PH) after a heart valve intervention.

Trial Health

On Track

Trial Health Score

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

Enrollment

200

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Apr 2009

Longer than P75 for phase_4

Geographic Reach

1 country

18 active sites

Status

completed

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

7.3 years study duration

First Submitted

Initial submission to the registry

March 13, 2009

Completed

3 days until next milestone

First Posted

Study publicly available on registry

March 16, 2009

Completed

16 days until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed

7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed

Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

7.3 years

First QC Date

March 13, 2009

Last Update Submit

September 22, 2016

Conditions

Pulmonary Hypertension Valvular Heart Disease

Keywords

Secondary Pulmonary HypertensionValvular Heart DiseasePhosphodiesterase-InhibitorsSildenafilOutcomes Research

Outcome Measures

Primary Outcomes (1)

Combined Outcome End-Point: all-cause mortality or hospital admission for heart failure, worsening of World Health Organization (WHO) functional class, or of the patient global assessment score
Six months

Secondary Outcomes (10)

Change from baseline to the sixth month in the in the six-minute walk test
6 Months
Change on WHO functional capacity
3 & 6 Months
All cause mortality
6 Months
Cardiovascular mortality
6 months
Number of hospital admissions caused by or related to heart failure in each patient
6 months
+5 more secondary outcomes

Study Arms (2)

Sildenafil Citrate

EXPERIMENTAL

Sildenafil Citrate 40 mg t.i.d. oral

Drug: Sildenafil Citrate

Placebo

PLACEBO COMPARATOR

Sildenafil-matched oral placebo 40 mg t.i.d

Drug: Placebo

Interventions

Sildenafil CitrateDRUG

40 mg t.i.d.

Sildenafil Citrate

PlaceboDRUG

Placebo t.i.d.

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age at the date of selection ≥ 18 years
Mean pulmonary pressure ≥ 30 mmHg, measured by a Swan-Ganz catheter placed in the pulmonary artery
Stable clinical condition for at least one month, without hospital admissions for heart failure, and on appropriate and stable doses of conventional cardiovascular medications

You may not qualify if:

Requiring or likely to require the following medications: organic nitrates, alpha-blocker therapy, potent cytochrome P450 3A4 inhibitors (erythromycin, ketoconazole, cimetidine, HIV protease inhibitors such ritonavir and saquinavir) Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months.
Patients with resting hypotension, with systolic blood pressure \< 90 mmHg
Patients with retinitis pigmentosa
Anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease) or patients who have conditions which may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia)
Severe renal impairment with creatinine clearance \< 30 ml/min
Significant hepatic dysfunction
Prosthesis or valvular dysfunction with hemodynamic repercussion.
Pregnant or breast-feeding women
Patients unlikely to cooperate in the study or with inability or unwillingness to give informed consent
Life expectancy less than 2 years due to non-cardiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Hospital General Universitario Gregorio Marañonlead
Instituto de Salud Carlos IIIcollaborator
Fundación de Investigación en Red en Enfermedades Cardiovascularescollaborator

Study Sites (18)

Hospital Universitario Santiago de Compostela

Santiago de Compostela, A Coruña, Spain

Location

Hospital Universitario Alava

Vitoria-Gasteiz, Alava, Spain

Location

Hospital German Trias y Pujol

Badalona, Barcelona, Spain

Location

Hospital de la Santa Creu y San Pau

Barcelona, Barcelon, Spain

Location

Hospital Reina Sofía

Córdoba, Córdoba, Spain

Location

Hospital Juan Canalejo

A Coruña, La Coruna, Spain

Location

Hospital de Leon

León, Leon, Spain

Location

Hospital Fundación de Alcorcón

Alcorcón, Madrid, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, Madrid, 28007, Spain

Location

Hospital 12 de Octubre

Madrid, Madrid, Spain

Location

Hospital Infanta Leonor

Madrid, Madrid, Spain

Location

Hospital Puerta de Hierro

Majadahonda, Madrid, Spain

Location

Hospital Virgen de la Victoria

Málaga, Malaga, Spain

Location

Hospital Universitario de Salamanca

Salamanca, Salamanca, Spain

Location

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Tenerife, Spain

Location

Hospital Clínico de Valladolid

Valladolid, Valladolid, Spain

Location

Hospital de Galdakao

Galdakao, Vizcaya, Spain

Location

Hospital Virgen de las Nieves

Granada, Spain

Location

Related Publications (2)

Bermejo J, Gonzalez-Mansilla A, Mombiela T, Fernandez AI, Martinez-Legazpi P, Yotti R, Garcia-Orta R, Sanchez-Fernandez PL, Castano M, Segovia-Cubero J, Escribano-Subias P, Alberto San Roman J, Borras X, Alonso-Gomez A, Botas J, Crespo-Leiro MG, Velasco S, Bayes-Genis A, Lopez A, Munoz-Aguilera R, Jimenez-Navarro M, Gonzalez-Juanatey JR, Evangelista A, Elizaga J, Martin-Moreiras J, Gonzalez-Santos JM, Moreno-Escobar E, Fernandez-Aviles F; SIOVAC ("Sildenafil for Improving Outcomes after VAlvular Correction") Investigators. Persistent Pulmonary Hypertension in Corrected Valvular Heart Disease: Hemodynamic Insights and Long-Term Survival. J Am Heart Assoc. 2021 Jan 19;10(2):e019949. doi: 10.1161/JAHA.120.019949. Epub 2021 Jan 5.
PMID: 33399006DERIVED
Bermejo J, Yotti R, Garcia-Orta R, Sanchez-Fernandez PL, Castano M, Segovia-Cubero J, Escribano-Subias P, San Roman JA, Borras X, Alonso-Gomez A, Botas J, Crespo-Leiro MG, Velasco S, Bayes-Genis A, Lopez A, Munoz-Aguilera R, de Teresa E, Gonzalez-Juanatey JR, Evangelista A, Mombiela T, Gonzalez-Mansilla A, Elizaga J, Martin-Moreiras J, Gonzalez-Santos JM, Moreno-Escobar E, Fernandez-Aviles F; Sildenafil for Improving Outcomes after VAlvular Correction (SIOVAC) investigators. Sildenafil for improving outcomes in patients with corrected valvular heart disease and persistent pulmonary hypertension: a multicenter, double-blind, randomized clinical trial. Eur Heart J. 2018 Apr 14;39(15):1255-1264. doi: 10.1093/eurheartj/ehx700.
PMID: 29281101DERIVED

MeSH Terms

Conditions

Hypertension, PulmonaryHeart Valve Diseases

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesHeart Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

Javier Bermejo, MD, PhD
Hospital General Universitario Gregorio Maranon
PRINCIPAL INVESTIGATOR

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

Study Record Dates

First Submitted

March 13, 2009

First Posted

March 16, 2009

Study Start

April 1, 2009

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

September 23, 2016

Record last verified: 2016-09

Locations

ES(18)

Sildenafil for Secondary Pulmonary Hypertension Due to Valvular Disease

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

Sildenafil Citrate

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (18)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

Sildenafil Citrate

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (18)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations