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Pulmonary HypertensionPhase 4SIOVACNCT00862043

Sildenafil for Secondary Pulmonary Hypertension Due to Valvular Disease

A Phase 4 study testing Sildenafil Citrate in people with Pulmonary Hypertension and Valvular Heart Disease, run by Hospital General Universitario Gregorio Marañon at 18 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sildenafil Citrate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
18 sitesSpain
Study dates
Apr 2009to Jul 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age at the date of selection ≥ 18 years
  • Mean pulmonary pressure ≥ 30 mmHg, measured by a Swan-Ganz catheter placed in the pulmonary artery
  • Heart valve intervention: surgical or percutaneous replacement, repair or dilatation performed at least one year before inclusion
  • Stable clinical condition for at least one month, without hospital admissions for heart failure, and on appropriate and stable doses of conventional cardiovascular medications

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Spain18 sites

  • Hospital Juan Canalejo

    A Coruña, La Coruna

  • Hospital Fundación de Alcorcón

    Alcorcón, Madrid

  • Hospital German Trias y Pujol

    Badalona, Barcelona

  • Hospital de la Santa Creu y San Pau

    Barcelona, Barcelon

  • Hospital Reina Sofía

    Córdoba, Córdoba

  • Hospital de Galdakao

    Galdakao, Vizcaya

  • Hospital Virgen de las Nieves

    Granada

  • Hospital de Leon

    León, Leon

  • Hospital General Universitario Gregorio Maranon

    Madrid, Madrid, 28007

  • Hospital 12 de Octubre

    Madrid, Madrid

  • Hospital Infanta Leonor

    Madrid, Madrid

  • Hospital Puerta de Hierro

    Majadahonda, Madrid

  • Hospital Virgen de la Victoria

    Málaga, Malaga

  • Hospital Universitario de Salamanca

    Salamanca, Salamanca

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife, Tenerife

  • Hospital Universitario Santiago de Compostela

    Santiago de Compostela, A Coruña

  • Hospital Clínico de Valladolid

    Valladolid, Valladolid

  • Hospital Universitario Alava

    Vitoria-Gasteiz, Alava

Other trials in Spain

About this study

Official title: Sildenafil for Improving Outcomes After Valvular Correction

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.

Read the detailed description

Phase IV, prospective, multicenter, randomized, double-blind, placebo-controlled, academically funded clinical trial, with 6 months follow-up. A total of 354 patients will be recruited. Inclusion criteria are: 1) successful surgical or percutaneous repair of a cardiac valve at least one year before screening and 2) persistent moderate or severe PH, and 3) absence of any residual significant valvular lesion. Patients will be randomized 1:1 to received sildenafil 40 mg t.i.d. or placebo. The primary endpoint is a clinical composite score combining: all-cause mortality, hospital admission for heart failure, World Health Organization (WHO) functional class, and the patient global assessment score. Additional clinical and mechanistic secondary end-points are defined.

Being tested
Sildenafil Citrate, Placebo
Keywords
Secondary Pulmonary Hypertension, Valvular Heart Disease, Phosphodiesterase-Inhibitors, Sildenafil, Outcomes Research
Medical subject headings
Hypertension, Pulmonary, Heart Valve Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sildenafil CitrateDrug

    40 mg t.i.d.

  • PlaceboDrug

    Placebo t.i.d.

Study groups in NCT00862043
Study groupRoleWhat they receive
Sildenafil CitrateExperimentalSildenafil Citrate 40 mg t.i.d. oral
Receives: Drug: Sildenafil Citrate
PlaceboPlacebo comparatorSildenafil-matched oral placebo 40 mg t.i.d
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Six months

Secondary outcomes (10)

  1. Change from baseline to the sixth month in the in the six-minute walk test

    Measured: 6 Months

  2. Change on WHO functional capacity

    Measured: 3 & 6 Months

  3. All cause mortality

    Measured: 6 Months

  4. Cardiovascular mortality

    Measured: 6 months

  5. Number of hospital admissions caused by or related to heart failure in each patient

    Measured: 6 months

  6. Rate of progression/regression of tricuspid regurgitation by Doppler-echocardiography

    Measured: 3 & 6 Months

  7. Change on right ventricular (RV) dimensions and function assessed by Doppler echocardiography

    Measured: 3 & 6 months

  8. Change on RV volumes and function assessed by cardiac magnetic resonance

    Measured: 6 Months

  9. Change on the right catheterization hemodynamic parameters

    Measured: 6 Months

  10. Identify patients who are more likely to respond to therapy by pharmacogenetics analysis

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00862043
Sponsor's protocol ID
FIBHGM-SIOVAC
Other IDs
2007-007033-40, EC07-90772
Acronym
SIOVAC
Status last verified
Sep 2016
First submitted
13 Mar 2009
Last updated
23 Sep 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 33399006

  • 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.

    PubMed 29281101

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sildenafil Citrate in people with Pulmonary Hypertension and Valvular Heart Disease, run by Hospital General Universitario Gregorio Marañon at 18 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00862043, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2016.

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