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Trial record 5 of 12 for:    scleroderma, systemic sclerosis AND Arterial Hypertension | Recruiting, Not yet recruiting, Available Studies

Endothelial Function in Patients With Scleroderma or Cirrhosis With and Without Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT01729611
Recruitment Status : Recruiting
First Posted : November 20, 2012
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Adriano Tonelli, The Cleveland Clinic

Brief Summary:

Pulmonary arterial hypertension (PAH) is a condition characterized by an increased pulmonary vascular resistance that can lead to right heart failure and death. Several diseases are known etiologies of PAH including scleroderma and cirrhosis. The presence of PAH in the context of systemic sclerosis or cirrhosis has a dramatic impact on prognosis and survival of the connective tissue or liver disease.

Despite advances in the diagnosis of PAH, echocardiography remains a necessary test for screening PAH in patients with scleroderma or cirrhosis. However, echocardiography is less than ideal for diagnosing PAH and predicting treatment response. Thus, there is a pressing need to identify methodologies that can accurately and non-invasively recognize the presence of PAH in patients with scleroderma and cirrhosis.

Hypothesis:

  1. To measure endothelial function and exhaled gases in patients with scleroderma and cirrhosis. To assess whether they correlate with the presence or the development of PAH.
  2. The degree of local (forearm) capillary vasodilation during treprostinil iontophoresis identifies patients who will develop PAH and in those already diagnosed PAH predicts response to PAH-specific therapies.

Condition or disease
Pulmonary Hypertension

Detailed Description:

Patients with scleroderma are known to have endothelial dysfunction and limited data suggested an association between the degree of endothelial function in scleroderma and the presence of PAH. However, these data is preliminary and has not been used to predict response to PAH-specific therapy or the development of PAH. We will test patients with cirrhosis because they tend to have PAH in the context of a hyperdynamic instead of a hypodynamic state as observed in scleroderma and PAH.

Aims:

  1. To measure endothelial function and exhaled gases in patients with scleroderma or cirrhosis to assess whether they correlate with the presence or the development of PAH.
  2. To evaluate the degree of endothelial response to local treprostinil iontophoresis and determine if this test can predict the development of pulmonary hypertension or response to PAH-specific therapies.

Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endothelial Function in Patients With Scleroderma or Cirrhosis With and Without Pulmonary Hypertension
Study Start Date : December 2013
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018


Group/Cohort
Scleroderma
60 patients with scleroderma - 30 with and 30 without Pulmonary Arterial Hypertension
Cirrhosis
60 patients with cirrhosis - 30 with and 30 without Pulmonary Arteria Hypertension



Primary Outcome Measures :
  1. Base Line [ Time Frame: up to 3 months ]
    Baseline characteristics in patients with and without PAH will be compared using parametric (t-test) and non parametric (Mann-Whitney) tests for continuous data and Chi-square for categorical data.



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Ages Eligible for Study:   17 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with scleroderma or cirrhosis. These patients may or may not have known PAH or be on treatment of this condition.
Criteria

Inclusion Criteria:

  • Patients with scleroderma or cirrhosis.

Exclusion Criteria:

  • Exclusion criteria include individuals younger than 16, etiologies of PAH other than scleroderma or cirrhosis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01729611


Contacts
Contact: Adriano Tonelli, MD 216.444.0812 tonella@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Adriano Tonelli, MD The Cleveland Clinic

Responsible Party: Adriano Tonelli, Staff Physician, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01729611     History of Changes
Other Study ID Numbers: Tonella1
First Posted: November 20, 2012    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017

Keywords provided by Adriano Tonelli, The Cleveland Clinic:
Scleroderma
Cirrhosis

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Scleroderma, Systemic
Scleroderma, Diffuse
Fibrosis
Liver Cirrhosis
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Connective Tissue Diseases
Skin Diseases