DyspneaMANPRONCT00143793

NT-proBNP and New Biomarkers in Patients With Dyspnea and/or Peripheral Edema

An observational study of Dyspnea and Peripheral Edema, run by Universitätsmedizin Mannheim at 1 site in Germany.

Completed

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

Trial summary

The objectives of this study are to: Evaluate the sensitivity and specificity of NT-proBNP (N-terminal prohormone brain natriuretic peptide) and new biomarker measurements for the diagnosis of heart failure in patients with acute dyspnea and/or edema. Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Dyspnea, Peripheral Edema
How many people: 400 participants
Where: 1 siteGermany
Study dates: Jun 2005to Dec 2019
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 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients suffering from dyspnea and peripheral edema

Who may be able to join

Age 18-90 years
Dyspnea or/and peripheral edema
Informed consent

Who cannot join

Renal insufficiency with creatinine > 2.8mg/dl
Anemia (hemoglobin < 8.0mg/dl)
Pregnancy

Trial locations and contacts

1 site in 1 country.

Germany1 site

Medical Faculty Mannheim, University of Heidelberg
Mannheim, Baden-Wurttemberg, 68167

Other trials in Germany

About this study

Official title: Mannheim NT-proBNP Study (MANPRO) Evaluating NT-proBNP and New Biomarkers in Patients Suffering From Dyspnea and/or Peripheral Edema for the Differential Diagnosis of Congestive Heart Failure

The objectives of this study are to:

Evaluate the sensitivity and specificity of NT-proBNP (N-terminal prohormone brain natriuretic peptide) and new biomarker measurements for the diagnosis of heart failure in patients with acute dyspnea and/or edema.
Determine the exact biomarker cut-off point(s) for the differentiation of healthy persons, patients with heart failure and patients with dyspnea of other origin.
Evaluate treatment costs in patients with dyspnea under special consideration of NT-proBNP measurement.

Read the detailed description

Primary endpoint:

Sensitivity and specificity of biomarker measurements for discrimination of heart failure from dyspnea of other origin.

Secondary endpoints:

Determination of Cut-off(s)
Discrimination of cardiac and non-cardiac diseases causing to dyspnea or peripheral edema
Determination of treatment costs of the initial hospital stay
Evaluation of resource savings when implementing NT-proBNP for determination of diagnosis.
Time to diagnosis.
Hospitalization rate /Intensive care treatment rate between day 1 and 28
Duration of initial hospital stay
30-day re-hospitalization rate
30 day mortality rate and adverse event rate
1 and 5 year mortality rates
1 and 5 year rehospitalization rates

Conditions: Dyspnea, Peripheral Edema
Keywords: natruretic peptides, NT-proBNP, new biomarkers, congestive heart failure, atrial fibrillation, acute myocardial infarction, lung embolism
Medical subject headings: Dyspnea, Heart Failure, Atrial Fibrillation, Pulmonary Embolism

Timeline

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

Jun 2005Dec 2019

First posted2 Sep 2005 (estimated)
Study startJun 2005
Primary completionDec 2018
Study completionDec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for DyspneaStudies 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: 400 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00143793
Sponsor's protocol ID: 80/05
Acronym: MANPRO
Status last verified: Aug 2020
First submitted: 31 Aug 2005
Last updated: 27 Aug 2020
Results posted: No
Data monitoring committee: No

Publications

Hoffmann U, Espeter F, Weiss C, Ahmad-Nejad P, Lang S, Brueckmann M, Akin I, Neumaier M, Borggrefe M, Behnes M. Ischemic biomarker heart-type fatty acid binding protein (hFABP) in acute heart failure - diagnostic and prognostic insights compared to NT-proBNP and troponin I. BMC Cardiovasc Disord. 2015 Jun 14;15:50. doi: 10.1186/s12872-015-0026-0.
PubMed 26072112
Behnes M, Brueckmann M, Lang S, Weiss C, Ahmad-Nejad P, Neumaier M, Borggrefe M, Hoffmann U. Connective tissue growth factor (CTGF/CCN2): diagnostic and prognostic value in acute heart failure. Clin Res Cardiol. 2014 Feb;103(2):107-16. doi: 10.1007/s00392-013-0626-6. Epub 2013 Oct 22.
PubMed 24146089
Behnes M, Brueckmann M, Lang S, Espeter F, Weiss C, Neumaier M, Ahmad-Nejad P, Borggrefe M, Hoffmann U. Diagnostic and prognostic value of osteopontin in patients with acute congestive heart failure. Eur J Heart Fail. 2013 Dec;15(12):1390-400. doi: 10.1093/eurjhf/hft112. Epub 2013 Jul 12.
PubMed 23851388

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mannheim NT-proBNP Study (MANPRO) Evaluating NT-proBNP and New Biomarkers in Patients Suffering From Dyspnea and/or Peripheral Edema for the Differential Diagnosis of Congestive Heart Failure
ClinicalTrials.gov ID: NCT00143793
Acronym / sponsor ID: MANPRO / 80/05
Conditions: Dyspnea, Peripheral Edema
Keywords: natruretic peptides, NT-proBNP, new biomarkers, congestive heart failure, atrial fibrillation, acute myocardial infarction, lung embolism
Study type: Observational
Recruitment status: Completed
Enrolment: 400 participants (estimated)
Lead sponsor: Universitätsmedizin MannheimUniversity, hospital or other
Study start: Jun 2005 (actual)
Primary completion: Dec 2018 (actual)
Study completion: Dec 2019 (actual)
First posted: 2 Sep 2005 (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.

The objectives of this study are to:

Evaluate the sensitivity and specificity of NT-proBNP (N-terminal prohormone brain natriuretic peptide) and new biomarker measurements for the diagnosis of heart failure in patients with acute dyspnea and/or edema.
Determine the exact biomarker cut-off point(s) for the differentiation of healthy persons, patients with heart failure and patients with dyspnea of other origin.
Evaluate treatment costs in patients with dyspnea under special consideration of NT-proBNP measurement.

Detailed description

Primary endpoint:

Sensitivity and specificity of biomarker measurements for discrimination of heart failure from dyspnea of other origin.

Secondary endpoints:

Determination of Cut-off(s)
Discrimination of cardiac and non-cardiac diseases causing to dyspnea or peripheral edema
Determination of treatment costs of the initial hospital stay
Evaluation of resource savings when implementing NT-proBNP for determination of diagnosis.
Time to diagnosis.
Hospitalization rate /Intensive care treatment rate between day 1 and 28
Duration of initial hospital stay
30-day re-hospitalization rate
30 day mortality rate and adverse event rate
1 and 5 year mortality rates
1 and 5 year rehospitalization rates

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients suffering from dyspnea and peripheral edema

Key inclusion criteria (3 listed)

Age 18-90 years
Dyspnea or/and peripheral edema
Informed consent

Key exclusion criteria (3 listed)

Renal insufficiency with creatinine > 2.8mg/dl
Anemia (hemoglobin < 8.0mg/dl)
Pregnancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Not reported in the source record.

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 27 Aug 2020.
Derived from this study: PubMed 26072112Hoffmann U, Espeter F, Weiss C, Ahmad-Nejad P, Lang S, Brueckmann M, Akin I, Neumaier M, Borggrefe M, Behnes M. Ischemic biomarker heart-type fatty acid binding protein (hFABP) in acute heart failure - diagnostic and prognostic insights compared to NT-proBNP and troponin I. BMC Cardiovasc Disord. 2015 Jun 14;15:50. doi: 10.1186/s12872-015-0026-0.
Derived from this study: PubMed 24146089Behnes M, Brueckmann M, Lang S, Weiss C, Ahmad-Nejad P, Neumaier M, Borggrefe M, Hoffmann U. Connective tissue growth factor (CTGF/CCN2): diagnostic and prognostic value in acute heart failure. Clin Res Cardiol. 2014 Feb;103(2):107-16. doi: 10.1007/s00392-013-0626-6. Epub 2013 Oct 22.
Derived from this study: PubMed 23851388Behnes M, Brueckmann M, Lang S, Espeter F, Weiss C, Neumaier M, Ahmad-Nejad P, Borggrefe M, Hoffmann U. Diagnostic and prognostic value of osteopontin in patients with acute congestive heart failure. Eur J Heart Fail. 2013 Dec;15(12):1390-400. doi: 10.1093/eurjhf/hft112. Epub 2013 Jul 12.

Related trials for Dyspnea

Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruiting
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Recruiting
The Impact of Telemedicine, Using the Caller's Mobile Phone Camera, on the Quality of Care Provided to Adult Patients Contacting the 15 Centre for Acute Dyspnea
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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.

Martina Brueckmann, MD study chair

First Department of Medicine, University Medical Centre Mannheim

Martin Borggrefe, MD study chair

First Department of Medicine, University Medical Centre Mannheim

Michael Neumaier, MD principal investigator

Institute of Clinical Chemistry, University Medical Centre Mannheim

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 Dyspnea and Peripheral Edema, run by Universitätsmedizin Mannheim 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 3 inclusion and 3 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 27 Aug 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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00143793, which also lists 3 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 27 Aug 2020.