Pulmonary HypertensionNCT03039972
Changes in Renal Function and Body Composition in Pulmonary Hypertension
An observational study of Pulmonary Hypertension and Renal Function Abnormal, run by University of Giessen at 1 site in Germany.
Trial summary
Changes in renal function and body composition in patients with pulmonary hypertension Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Hypertension, Renal Function Abnormal
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 25 Jan 2017to 9 Jul 2020
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with suspected or pre-diagnosed pulmonary hypertension at pulmonary hypertension outpatient clinic, University Hospital Giessen and Marburg, Campus Giessen
Who may be able to join
- Subjects older than 18 years at pulmonary hypertension outpatient clinic
- Subjects who signed informed consent forms
Who cannot join
- Patients refusing to participate or withdraw consent during follow-up
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Clinic Giessen and Marburg - Campus Giessen
Giessen, Hesse, 35392
About this study
Official title: Prospective Evaluation of Changes in Renal Function and Body Composition in Patients With Pulmonary Hypertension
Changes in renal function and body composition in patients with pulmonary hypertension
Read the detailed description
This prospective single-center study is designed to analyze changes in renal function and body composition in patients with suspected or pre-diagnosed pulmonary hypertension at pulmonary hypertension outpatient clinic, University Hospital Giessen and Marburg, Campus Giessen.
- Conditions
- Pulmonary Hypertension, Renal Function Abnormal
- Being tested
- No intervention
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDiagnostic test
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Hypertension | Adult outpatients with suspected or prediagnosed pulmonary hypertension irrespective of subclass and all chronic kidney disease stages Receives: Diagnostic Test: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in renal function in patients with pulmonary hypertension
Estimated GFR based on Chronic Kidney Disease Epidemiology Collaboration-creatinine-cystatin C will be used to determine renal function at baseline and at 1 year follow-up
Measured: 1 year
Secondary outcomes (3)
Changes in hydration status in patients with pulmonary hypertension
Bioimpedance analysis will be used to determine hydration status at baseline and at 1 year follow-up
Measured: 1 year
Changes in nutritional status in patients with pulmonary hypertension
Bioimpedance analysis will be used to determine lean tissue and fat mass at baseline and at 1 year follow-up
Measured: 1 year
Prognostic value of baseline renal function, hydration and nutritional status on pulmonary hypertension-associated morbidity and mortality
pulmonary hypertension-associated morbidity and mortality (defined as escalation of pulmonary hypertension-specific therapy, unscheduled hospitalization and all-cause mortality) will be prospectively assessed during follow-up period
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start25 Jan 2017
- Primary completion7 Oct 2019
- Study completion9 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faeq Husain, University of Giessen
- Investigators
- Werner Seeger, MD, Study director, Department of Internal Medicine II, Division of Pulmonology, Nephrology and Critical Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039972
- Sponsor's protocol ID
- AZ 239/16
- Status last verified
- Dec 2020
- First submitted
- 29 Jan 2017
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Bellomo R, Prowle JR, Echeverri JE. Diuretic therapy in fluid-overloaded and heart failure patients. Contrib Nephrol. 2010;164:153-163. doi: 10.1159/000313728. Epub 2010 Apr 20.
PubMed 20428001Ronco C, Verger C, Crepaldi C, Pham J, De Los Rios T, Gauly A, Wabel P, Van Biesen W; IPOD-PD Study Group. Baseline hydration status in incident peritoneal dialysis patients: the initiative of patient outcomes in dialysis (IPOD-PD study)dagger. Nephrol Dial Transplant. 2015 May;30(5):849-58. doi: 10.1093/ndt/gfv013. Epub 2015 Mar 11.
PubMed 25762355Navaneethan SD, Wehbe E, Heresi GA, Gaur V, Minai OA, Arrigain S, Nally JV Jr, Schold JD, Rahman M, Dweik RA. Presence and outcomes of kidney disease in patients with pulmonary hypertension. Clin J Am Soc Nephrol. 2014 May;9(5):855-63. doi: 10.2215/CJN.10191013. Epub 2014 Feb 27.
PubMed 24578332Damman K, van Deursen VM, Navis G, Voors AA, van Veldhuisen DJ, Hillege HL. Increased central venous pressure is associated with impaired renal function and mortality in a broad spectrum of patients with cardiovascular disease. J Am Coll Cardiol. 2009 Feb 17;53(7):582-588. doi: 10.1016/j.jacc.2008.08.080.
PubMed 19215832
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Changes in Renal Function and Body Composition in Patients With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT03039972
- Acronym / sponsor ID
- AZ 239/16
- Conditions
- Pulmonary Hypertension, Renal Function Abnormal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- 25 Jan 2017 (actual)
- Primary completion
- 7 Oct 2019 (actual)
- Study completion
- 9 Jul 2020 (actual)
- First posted
- 1 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Changes in renal function and body composition in patients with pulmonary hypertension
Detailed description
This prospective single-center study is designed to analyze changes in renal function and body composition in patients with suspected or pre-diagnosed pulmonary hypertension at pulmonary hypertension outpatient clinic, University Hospital Giessen and Marburg, Campus Giessen.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Hypertension | – | Diagnostic Test: No interventionAdult outpatients with suspected or prediagnosed pulmonary hypertension irrespective of subclass and all chronic kidney disease stages |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with suspected or pre-diagnosed pulmonary hypertension at pulmonary hypertension outpatient clinic, University Hospital Giessen and Marburg, Campus Giessen
Key inclusion criteria (2 listed)
- Subjects older than 18 years at pulmonary hypertension outpatient clinic
- Subjects who signed informed consent forms
Key exclusion criteria (1 listed)
- Patients refusing to participate or withdraw consent during follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Diagnostic test | Pulmonary Hypertension |
Primary outcome
Changes in renal function in patients with pulmonary hypertension
Time frame: 1 year
Estimated GFR based on Chronic Kidney Disease Epidemiology Collaboration-creatinine-cystatin C will be used to determine renal function at baseline and at 1 year follow-up
3 secondary outcomes
Changes in hydration status in patients with pulmonary hypertension
Time frame: 1 year
Changes in nutritional status in patients with pulmonary hypertension
Time frame: 1 year
Prognostic value of baseline renal function, hydration and nutritional status on pulmonary hypertension-associated morbidity and mortality
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Background: PubMed 20428001Bellomo R, Prowle JR, Echeverri JE. Diuretic therapy in fluid-overloaded and heart failure patients. Contrib Nephrol. 2010;164:153-163. doi: 10.1159/000313728. Epub 2010 Apr 20.
- Background: PubMed 25762355Ronco C, Verger C, Crepaldi C, Pham J, De Los Rios T, Gauly A, Wabel P, Van Biesen W; IPOD-PD Study Group. Baseline hydration status in incident peritoneal dialysis patients: the initiative of patient outcomes in dialysis (IPOD-PD study)dagger. Nephrol Dial Transplant. 2015 May;30(5):849-58. doi: 10.1093/ndt/gfv013. Epub 2015 Mar 11.
- Results publication: PubMed 24578332Navaneethan SD, Wehbe E, Heresi GA, Gaur V, Minai OA, Arrigain S, Nally JV Jr, Schold JD, Rahman M, Dweik RA. Presence and outcomes of kidney disease in patients with pulmonary hypertension. Clin J Am Soc Nephrol. 2014 May;9(5):855-63. doi: 10.2215/CJN.10191013. Epub 2014 Feb 27.
- Results publication: PubMed 19215832Damman K, van Deursen VM, Navis G, Voors AA, van Veldhuisen DJ, Hillege HL. Increased central venous pressure is associated with impaired renal function and mortality in a broad spectrum of patients with cardiovascular disease. J Am Coll Cardiol. 2009 Feb 17;53(7):582-588. doi: 10.1016/j.jacc.2008.08.080.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Werner Seeger, MD study director
Department of Internal Medicine II, Division of Pulmonology, Nephrology and Critical Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension and Renal Function Abnormal, run by University of Giessen at 1 site in Germany.
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 2 inclusion and 1 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 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Changes in renal function in patients with pulmonary hypertension (time frame: 1 year). 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 NCT03039972, which also lists 4 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 17 Dec 2020.