Evidence map›Paper›PMID 38689245›Full record

ArticleBMC pulmonary medicine2024

Sildenafil Versus Placebo for Early Pulmonary Vascular Disease in Scleroderma (SEPVADIS): protocol for a randomized controlled trial.

Matthew R Lammi, Monica Mukherjee, Lesley Ann Saketkoo, Kyle Carey, Laura Hummers, Steven Hsu, Amita Krishnan, Marie Sandi, Ami A Shah, Stefan L Zimmerman and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC pulmonary medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04797286 (Sildenafil for Early Pulmonary Vascular Disease in Scleroderma), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 37% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04797286 phase2recruitingnot on this map

Sildenafil for Early Pulmonary Vascular Disease in Scleroderma

TypeinterventionalSponsorJohns Hopkins UniversityRan2021 to 2026Enrolled30ConditionsScleroderma, Mildly Elevated Pulmonary PressuresArmsSildenafil, Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 1 citations in OpenAlex.

  1. Management of pulmonary arterial hypertension in systemic sclerosis: from classical treatments to new horizons.European respiratory review : an official journal of the European Respiratory Society · 2026
    Pooled it
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 4 institutions in 1 country.

Matthew R LammiLouisiana State University Health Sciences, 1901 Perdido St, 70112, New Orleans, LA,, USA. mlammi2@jh.edu.
Monica MukherjeeDivision of Cardiology, Johns Hopkins University, Baltimore, USA.
Lesley Ann SaketkooNew Orleans Scleroderma and Sarcoidosis Patient Care and Research Center, New Orleans, USA.
Kyle CareyInstitute for Clinical and Translational Medicine, Johns Hopkins University, Baltimore, USA.
Laura HummersJohns Hopkins University, Division of Rheumatology, Baltimore, USA.
Steven HsuDivision of Cardiology, Johns Hopkins University, Baltimore, USA.
Amita KrishnanLouisiana State University Health Sciences, 1901 Perdido St, 70112, New Orleans, LA,, USA.
Marie SandiLouisiana State University Health Sciences, 1901 Perdido St, 70112, New Orleans, LA,, USA.
Ami A ShahJohns Hopkins University, Division of Rheumatology, Baltimore, USA.
Stefan L ZimmermanJohns Hopkins University, Department of Radiology and Radiological Science, Baltimore, USA.
Paul M HassounJohns Hopkins University, Division of Pulmonary and Critical Care Medicine, Baltimore, USA.
Steven C MathaiJohns Hopkins University, Division of Pulmonary and Critical Care Medicine, Baltimore, USA.
Johns Hopkins University · USLouisiana State University Health Sciences Center New Orleans · USPulmonary Hypertension Association · USTulane University · US

Funding

Myocyte Mechanics of Right Ventricular Contractile Failure in Pulmonary Hypertension due to Heart Failure with Reduced Ejection FractionR01HL172830 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI Steven Hsu · 2024 to 2026
$2.0M
Mechanisms and treatment of right ventricular sarcomere dysfunction in scleroderma-associated pulmonary arterial hypertensionK23HL146889 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI HSU, STEVEN · 2019 to 2023
$886k
NHLBI NIH HHS K23 HL146889NHLBI NIH HHS R01 HL172830
6 · The paper itself

Abstract

backgroundPulmonary hypertension (PH) is a leading cause of death in patients with systemic sclerosis (SSc). An important component of SSc patient management is early detection and treatment of PH. Recently the threshold for the diagnosis of PH has been lowered to a mean pulmonary artery pressure (mPAP) threshold of > 20 mmHg on right heart catheterization (RHC). However, it is unknown if PH-specific therapy is beneficial in SSc patients with mildly elevated pressure (SSc-MEP, mPAP 21-24 mmHg).

methodsThe SEPVADIS trial is a randomized, double-blind, placebo-controlled phase 2 trial of sildenafil in SSc-MEP patients with a target enrollment of 30 patients from two academic sites in the United States. The primary outcome is change in six-minute walk distance after 16 weeks of treatment. Secondary endpoints include change in pulmonary arterial compliance by RHC and right ventricular function by cardiac magnetic resonance imaging at 16 weeks. Echocardiography, serum N-terminal probrain natriuretic peptide, and health-related quality of life is being measured at 16 and 52 weeks. DISCUSSION: The SEPVADIS trial will be the first randomized study of sildenafil in SSc-MEP patients. The results of this trial will be used to inform a phase 3 study to investigate the efficacy of treating patients with mild elevations in mPAP.

trial registrationClinicalTrials.gov Identifier NCT04797286.

Indexed as

Hypertension, PulmonaryQuality of LifeScleroderma, SystemicSildenafil CitrateAdultCardiac CatheterizationClinical Trials, Phase II as TopicDouble-Blind MethodEchocardiographyFemaleHumansMaleMiddle AgedNatriuretic Peptide, BrainPeptide FragmentsPulmonary ArteryNatriuretic Peptide, BrainPeptide Fragmentspro-brain natriuretic peptide (1-76)Sildenafil CitrateVasodilator AgentsClinical trialPulmonary hypertensionSclerodermaSildenafilSystemic sclerosis

Identifiers

PMID38689245
PMCPMC11061972
OpenAlexW4396561354

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.